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The best-read anesthesiology publication in the United States


anesthesiologynewss • N o v e m b e r 2 0 1 3 • Volume 39 Number 11



Misconduct May Take Bloom Off β-Blocker Rx


he debate over usin ng β-blockers perioperaatively for non-cardiacc surgery patients continues with a new meta-analysis from British researchers indicating that starting thee drugs specifically for surgery can increase a patient’s risk for death h bby 27%. % Reporting in Heartt (doi:10.1136/heart-jnl-2013304262 [Epub ahead of print]), investigators from Imperial College, in London, reviewed nine studies of perioperative β-blocker use in 10,529 patients, and found that β-blockers caused a “statistically and clinically significant increase in mortality.” Analyzing six of the studies, the team found that β-blockers reduced the risk for non-fatal myocardial infarction (MI) (relative see β-blocker page 26

Propofol Dosing By Weight May Shortchange Obese Patients


linicians should use bispectral index values to guide propofol indduction in patients with morbid obesity, according to Canadian researchers who found that BIS values are better than boddy weight in this population. The randomized study, which com mpared the efficacy of propofol target induction doses calculated using lean boddy weight (LBW), found the doses based on LBW were consistently lower than those based on the BIS monitoring (Covidien) and resulted in insufficient depth of anesthesia in 60% of cases. Many anesthesiologists use LBW to determine propofol dosing in bariatric surgerr y. But see propofol pa age 30

Anesthesiologist-Designed Portable ICU Has Military and Civilian Uses Toronto—At a chance meeting in 2002, retired Master Chief Thomas Eagles, a highly decorated medic in the U.S. Marine Corps, approached Joseph Fisher, MD, a highly bookish anesthesiologist-turnedinnovator.r Mr. Eagles had heard of Dr. Fisher’s research on improving the efficiency of oxygen delivery, and wanted him to lower the number of oxygen tanks that medics had to carry into the field. “When he asked me, I said, ‘Oh, for sure I can reduce the number of oxygen tanks—possibly even eliminate them altogether,’” Dr. Fisherr recalled recently. “I have no idea why he would believe me, but he did.” There are some good reasons to eliminate oxygen tanks in the field, according to Dr. Fisher, founder

6 16 of and chief scientist at Thornhill Research, Inc., in Toronto, Canada, a technology transfer company affiliated with the University of Toronto, where he is professor of medicine. “Helicopter pilots don’t want to fly with them because they may explode if they are struck by a see portable page 11

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Adductor canal block bests femoral for early ambulation after TKA.

April 11-13, 2014

The Cosmopolitan of Las Vegas

Advanced Institute for Anesthesia Practice Management Securing the Future for Anesthesia Practices

The Advanced Institute for Anesthesia Practice Management (formerly the Anesthesia Billing & Practice Management Seminar) will be held April 11–13, 2014 at The Cosmopolitan of Las Vegas. The 2014 Advanced Institute for Anesthesia Practice Management will focus on practice management issues with the goal of enlightening attendees on broader group strategy issues, including numerous talks on billing, coding and compliance.

For full conference information and to register for the AIAPM Conference, please visit or email

20 CME Credits

Conference Speakers Frank Rosinia, MD Chairman, Department of Anesthesiology Tulane University School of Medicine, New Orleans, LA Michael Hicks, MD, MBA, FACHE President and Chairman, Pinnacle Anesthesia Consultants, PA, Dallas, TX Howard Greenfield, MD Principal, Enhance Healthcare, Aventura, FL Sonya Pease, MD, MBA Chief Medical Officer, TeamHealth Anesthesia, Palm Beach Gardens, FL Pam Upadya, MD Associate Director, Anesthesia Residency Program St. Joseph’s Regional Medical Center Compliance Officer, New Jersey Anesthesia Group, PA, Patterson, NJ

John Kirsner, Esq. Squire Sanders LLP, Washington, DC Neda Ryan, Esq. Clark Hill PLC, Birmingham, MI Marvel J. Hammer, RN, CPC, CCS-P, PCS, ACS-PM, CHCO MJH Consulting, Denver, CO Kelly Dennis, MBA, ACS-AN, CAN-PC, CHCA, CPC, CPC-I Perfect Office Solutions, Inc., Leesburg, FL Judy Wilson, CPC, CPC-H, CPCO, CPPM, CPC-P, CPC-I, CANPC Business Administrator, Anesthesia Specialists, Virginia Beach, VA

sav e

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Will Latham, MBA, CPA Latham Consulting Group, Chattanooga, TN David Queen, JD Queen Law Group, Pasadena, CA Mark F. Weiss, Esq. Advisory Law Group, Los Angeles, CA Bob Johnson, MBA Vice President – Hospital Based Physician Services Hospital Corporation of America (HCA), Baltimore, MD Amy Mowles President & CEO, Mowles Medical Practice Management, Edgewater, MD William Britton, MBA Co-Founder and Managing Director, Cross Keys Capital, LLC, Ft. Lauderdale, FL


Make An Educated Decision Information You Need To Be Informed and Stay Competitive Anesthesia Business Consultants (ABC) believes the more you know, the better the decisions you can make. ABC places the highest value on continuing education. As the health care world continues to evolve, offering new technological advances and business models, along with changing laws and regulations, it’s imperative to keep informed. We provide our clients and associates regular updates on what is happening in the world of anesthesiology through our weekly eAlerts. These Alerts highlight the very latest in developments, changing requirements and opportunities and are a complimentary service. If you are interested in receiving these Alerts just send your name, e-mail address, the name of your practice or company, city and state to ABC is also pleased to offer the Communiqué, our quarterly newsletter, to interested individuals. It is available electronically as well as in print. The Communiqué features articles written by industry leaders focusing on the latest hot topics in group management, compliance and future business models for anesthesiologists, nurse anesthetists, pain management specialists and anesthesia practice administrators. We look forward to providing you with many more years of practice management news through the Communiqué and our weekly Alerts. Please log on to ABC’s web site at and click on the “Publications” link to view the electronic version of the Communiqué online or to see copies of our previous Alerts. ABC does not share this list with any third parties nor use it for purposes other than distributing the Alerts, the quarterly Communiqués and the very occasional special announcement. If you have any questions or would like additional information please call 517-787-6440 x 4113, send an email to, or visit our website at This communication is for educational informational purposes only and is not intended or offered as legal advice.

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Heard Here First: The core

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2. End-Tidal Carbon Dioxide: The Most Vital of Vital Signs (Educational Review)


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means their pain is imaginary. It is a worry many patients carry. We try to make them understand that their pain is

3. Personal CPAP Machines in PACU of Uncertain Benefit 4. NPO: Never Precisely Originated, Not Prudently Ordered

absolutely real.

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Surfing the Bore Tide: a Surgeon’s Take On America’s Changing Health Care System


hen I lived in Alaska, everyone knew preparation for this (which, by the way, is so critical someone who had died, whether seasoned and yet so unexamined among surgeons) is not necoutdoorsman or novice. Extreme weather, essarily what prepares us to see beyond one patient solitude and the wilderness are part of the allure of or to be trusting of, well, anyone. We are trained to Alaska, but even small mistakes can have big conse- be accountable for every aspect of the perioperative quences there. Exposure. Capsized boats. Floatplane patient’s care. Their outcome, our reputation, and crashes. Lost footing on a trail. Animal encounters. our sense of well-beingg and worthiness beyond what others think, depend on our shouldering responsibilEven bad divorces. But some stories grip the imagination and are told ity for the operation. On the other hand, we have been the cats who over and over again. One such apocryphal tale is of an obese woman fishing alone in her boat who swish our tails and lick our paws, looking on with cast anchor before turning in for the night but mis- disdain at any attempts to herd us. Could a group gauged the bay’s depth and the speed of the incom- of surgeons in a community hospital or an academic ing tide. As the tide rushed in, the anchored end of department agree to meet and negotiate contracts the boat tilted, ice-cold sea water rushed over the for operating room equipment? Could it ever hapdeck and the cabin door at the aft end submerged pen that the robustly experienced robotic urologic before she awakened to discover the crisis. By then, surgeon would cede his suite or compromise in any the cabin door could not be opened, and she was too measure to ease the way for a less-experienced robotic large to escape through a cabin window. Her plight surgeon? Could laparoscopic surgeons evaluate stais haunting: trapped not just in her boat but in her pling devices and assess the needs of a group, sifting body, waiting to die as minutes filled hours, hoping through preferences, data and critical requirements for hypothermia to numb the senses before the inevi- to make unified purchasing recommendations? It’s table drowning. hard to imagine. We are seen as thoughtless spendPerhaps this story is a kind of cautionary tale. Like thrifts who are swayed by sales reps like children in the bore tide in Cook Inlet which can flood at up to a candy store. We commonly step on one another to 15 mph, the incoming tide of legislation and corpo- assert our own needs and establish our place. In the ratization of surgical practice seems insurmountable, wake of our disputes, we leave the distinct impresf servingg prima donnas who are and we are like the obese fisherwoman, sleeping in sion that we are selfher cabin. There is no doubt in my mind that we have best governed by more altruistic nurses and adminiscontributed to our own potential professional demise trators. Such stubbornness and lack of insight pit us by failing to reckon with the changing circumstances— against one another and seal our fate to drown in the cultural and financial—in which we work. cabin of our small boats. A colleague was recently censured for exclaimOn the one hand, a kind of fierce autonomy is necessary to function as a surgeon. “Trust no one.” This ing, “F@#%!” in a challenging case. An instrument is a dictum of training and practice. A poem purport- he routinely used for this procedure was missing. edly composed by a surgeon was recited to me in medical school by an increduIn the allegorical wilderness of the lous internist: Row upon serried row, they sit. All masters to the rule. But there is only one, my friend, Who has to fight the bull.

operating room, seemingly small divergences can have big consequences.

Medicine doctors, it counsels, can sit in the tiered bleachers of the historical operating theater, arguing about the differential diagnosis, its workk up and subsequent treatment; but in surgery, one person has to perform the operation. One person stands in the arena and “fights the bull.” To be sure, this is not at all the same as working alone. This task is never performed in complete isolation, but one person has made an operative plan with the patient and must not only see that patient through the implementation of the plan but also technically execute the plan. One person makes the incision and gains entrance to the inner sanctum of To appreciate the bore tide (pictured above), another human body. The psychological visit:

Several efforts to locate it were unsuccessful, and he tried four alternatives before he could complete the procedure. His stress level mounted as succes- Lauren Kosinski, MD sive alternatives proved to be inadequate substitutions. Perhaps he would have had difficulty even with the standard instrument, but his frustration was amplified by the absence of the familiar and dependable tool. It can be very lonely in the operating room—no one else could solve the problem for him; all they could do was bring what he needed, and even that wasn’t working, which can leave the surgeon feeling even more strained. Underlying this is always the anxiety of failing the patient, of being inadequate to a task that has high stakes. Every surgeon knows the frustration of the incorrect preference card. Each time we ask for something particular (a stouter 7-inch needle driver to close the fascia, a right angle with a finer tip to facilitate delicate dissection, or undyed 4-0 vicryl on a PS-2 not a PS-3), or when we are disgruntled about a substitution (Demerol must be used instead of fentanyl for colonoscopies today), we are seen as temperamental. Yet it is a hallmark of expertise to appreciate the differences between instruments, to know the nuances of each and to select it precisely. Every circulator loves the surgeon who makes do with what’s already on the back table, but every scrub tech wants the surgeon to be quite specific about what instrument to place in an outstretched hand. Chaos ensues when a surgeon is incapable of specifying what she or he needs. In the allegorical wilderness of the operating room, seemingly small divergences can have big consequences. A 1 or 2 cm displacement of a suprapubic port can make the difference between successful and unsuccessful stapled transection of the rectum in an ultra-low w laparoscopic proctectomy. Similarly sized endostaplers from different vendors may have identical performance parameters, but they will still not handle or behave identically. The discriminating surgeon will recognize these differences and learn to make adjustments, but the period of adjustment can have deleterious consequences for patients. The surgeon’s stress level is higher during the transition, as it should be. In addition to the patient’s well-being, the surgeon’s stature and selff worth—and potentially referrals and reimbursement—depend on achieving good operative outcomes. No one else in the operating room or the hospital bears that burden more vividly. Clinical decisions, material and instrument substitutions are sometimes relatively inconsequential or are made to realize the benefits of new technology, but the assessment of the magnitude of that impact and strategies for overcoming it cannot be made by administrators who do not use and depend on the performance of those supplies and equipment. My colleague’s behavior was not tolerated. Whether reported as merely temperamental or more see tide page 8

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seriously as disruptive, he depended on the resourcefulness of staff who had less visible and personal investment in the outcome than he did. After the report of his behavior, the instrument he needed was found 10 feet from the operating room in which he struggled. Where do we begin? How can we set anchor more thoughtfully and be more fit and flexible? How do we surf the bore tide rather than be swamped by it? Perhaps we can begin by taking small steps, by finding more effective ways to communicate our endeavor that more successfully draw team members into the solution. Paradoxically, at a time when it seems there is pressure to diminish the relative contribution of the surgeon to the performance of a successful operation, it actually may be critical to clarify it. This may require that we surgeons overcome maladaptive behaviors for reckoning with the psychological task of cutting another person open and hurting them to help them. We can minimize our awareness of this monumental event in a number of ways, one of which is to obscure just how remarkable it is. We make it mundane. We also tend to exteriorize or project outside of ourselves uncertainty and risk. We cultivate our own mythology that we have almost superhuman powers: We don’t need to sleep; we don’t need to eat; we don’t need to wear coats in cold weather or seatbelts in cars (Cult Med Psychiatry 1987;11:229-249). Like epiphytes that appear to live on air alone, we subsist on a steady diet of surgery, research and consultations. We may need to recognize our vulnerability, not in an angry and victimized way but rather as a matter of fact. We simply need the very best help we can get in the operating room and clinic. The environment must support our relaxed concentration. Every other person in the room can more easily take a break or Advertisement


be replaced. The surgeon cannot leave the job unfinished. We may need to admit that a little juju helps achieve this state of mind. We make choices because we have to, and then we wed ourselves to those choices because when we make as much of an operation as routine as possible, when we work out the little kinks and establish a mental template for what things ought to look like at every step of the procedure, things go more smoothly. We cannot settle for letting these positive adaptations be characterized negatively. “Master,” “expert,” “hero” and “heroine” are synonyms for prima donna. So, how do we reverse the tide? Perhaps we can’t reverse the tide, but we can adapt to changing needs and help shape expectations. We can ask for help. I may still be a bit naive, but I continue to believe that most people who work in health care were drawn to this work because they actually want to help. I also still believe that regardless of the skill level, every person derives satisfaction from a job they do well and basks in appreciation and the feeling that he or she

counts. We all want to be on a winning team. By asking for help and admitting exactly what we need and why, we let our team members know how much they matter. It’s possible, then, that instead of resenting what seems to be our demanding, dismissive attitude and healthier income, they might want to help protect our time and support our performance. We do not, despite our professional mythology, have endless private resources to draw on. Finally, by doing a better job of expressing our needs and limitations, our humanity, we might better account for what we can and cannot do and more faithfully take a seat at the table to help shape the decisions that affect us so profoundly. We can ride the tide more gracefully, in full cognition of our original intention and help chart the course, one step at a time, one conversation at a time, one honest moment of reflection at a time. —Lauren Kosinski, MD Dr. Kosinski is assistant professor of surgery at the Medical College of Wisconsin, in Milwaukee.

Fiction Showing Anesthesiologists Little Love


hen it comes to the portrayal of anesthesiCalling those traits “inaccurate,” they wrote, ology in literature, the specialty, like Rodney “[T]hese distortions fail to distinguish the importance Dangerfield, might be in search of a little respect. of the anesthesiologist’s role in patient safety.” A new study of novels and short stories in which That’s not to say all fictionalized anesthesiologists anesthesiologists have appeared found them to be are shiftless wastes of scrub suits. The main characservile, bumbling, lazy and generally less competent ter in Paris Twilight, t a new novel by Russ Rymer, for and charismatic than their colleagues holding the example, is a prominent cardiovascular anesthesioloscalpels. gist called to France to assist in a mysterious surgery. Yvon Yvon, MD, of Wake Forest University School But the study authors suggest that the misrepof Medicine, in Winston-Salem, N.C., and a colresentation of anesthesiologists in fiction reflects a league, Molly Perini, reviewed nine works of fiction lack of familiarity with the specialty. “Anesthesiolobetween 1962 and 1998. Five of the authors were gists should clear up the confusion by either writing physicians—but none was an anesthesiologist. Even their own fiction or pointing out the errors in fiction,” so (or, perhaps because of that), anesthesiology as they wrote. a profession was depicted in a much less flattering The researchers presented their findings at the light than surgery. 2013 annual meeting of the American Society of “Five themes characterizing anesthesiologists Anesthesiologists (abstract 3224). emerged in the literature: inferiority, error prone, lazy, —Adam Marcus cowardly and servile,” the researchers reported.

Table. Anesthesiologists in Fiction Anesthesia Circuit Kits, From Dräger Medical, Inc. Dräger’s Anesthesia Circuit Kits offer exceptional value by combining our high-quality anesthesia consumables into one complete solution. Depending on your kit’s configuration, key components are preassembled—making them out-of-bag ready for your anesthesia device. A clutter-free workspace helps you focus on your patient and prepare for the next case with less effort.

Year Published



Anesthesiologist Character

Surgeon/Other Character

Attributes of Anesthesiologists


“The Interns”

Richard Frede

Dr. Jay Fishbein




“A Case of Need”

Michael Crichton

Dr. Herbert Landsman

Dr. Frank Conway

Error prone


“Kingsley’s Touch”

John Collee

Dr. Richard Short

Dr. Alistair Kingsley



Bleeders Come First, t in “The Houseman’s Trilogy”

Colin Douglas (geriatrics)

Dr. Bill

Dr. David Campbell

Lazy, error prone


The Greatest Breakthrough Since Lunchtime, in “The Houseman’s Trilogy”

Colin Douglas (geriatrics)

Dr. Baird-Brown

Dr. Orr




Neil Ravin (endocrinology)

Dr. Jose Cruz

Dr. McIlheny


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Honk if You Are Jesus

Peter Goldsworthy (family medicine)

Dr. Max Henning

Dr. Mara Fox

Servile, inferior


Open Heart

A.B. Yehoshua

Dr. Nakash

Dr. Rubin

Error prone


Sarcophagus, in “The Doctor Stories”

Richard Selzer (surgeon)

Dr. David


Servile, cowardly



Medication Adherence in the Palm of Your Hand “The smartphone will see you now.”


hat, declared noted cardiologist and technology guru Eric Topol, MD, might well be the motto for the next generation of health care. In a wide-rangingg keynote address at the Armada Specialty Pharmacy Summit, Dr. Topol, chief of innovative medicine at Scripps Research Institute, La Jolla, Calif., described an array of new remote monitoring and diagnostic options that are either already available or coming soon to a smartphone, tablet or computer near you, including apps that measure and track lung function, blood sugar, heart rate and blood pressure, and can even perform an electrocardiogram. Such personalized digital intervention (PDI) tools enable health care providers to tailor care more specifically for individual patients, noted Al Babbington, CEO of PrescribeWellness, a company that provides cloud-based provider-to-patient communications. Such PDI “technologies must be more effectively leveraged to provide patients the support necessary to improve outcomes,” Mr. Babbington said during the Centers for Disease Control and Prevention’s recent Conference on Health Communication, Marketing and Media.

Remote monitoring by smartphone and other technologies is likely to transform the practice of pharmacy within the next few years, and holds particular promise for solving—or at least mitigating—a challenge that has long confounded pharmacists: patient nonadherence. One example: eMedonline, a “medication adherence telehealth platform” that already has secured multiple rounds of National Institutes of Health funding. It works on multiple platforms— smartphones, BlackBerry, and for patients without such devices, a basic Internet appliance from the company. This tool gives “the patient a reminder on their phone or their device when it’s time to take a specific dose of medication,” said Kevin Clauson, PharmD, associate professor of pharmacy practice at Nova Southeastern University, in Fort Lauderdale, Fla. “Then, they have to use the camera on their phone or a scanning app to scan the specific bottle or pill that they’re taking. The program then confirms that they’re getting the right drug, at the right dose, at the right time.” In some cases, the patient is then prompted to answer a few questions about the medication via text, such as “how do you feel this drug is working for you?” and “what side effects have you noticed? noticed?” The data can be ussed to do predictive moddeling, Dr. Clauson saaid. “For example, if the daata shows that your patieent is usually taking all of their doses correcctly,

‘With a biosensor, you know where and when the patient takes the drug. ... That’s not a proxy, that’s [evidence of] actual adherence.’ —Kevin Clauson, PharmD but on Tuesday afternoons they often miss a dose, you can pinpoint what might be happening then. The patient might realize, ‘Oh, that’s when I take Ella to soccer, and there’s so much going on that I forget.’ So, you can develop nonpharmacologic interventions to help the pharmacologic piece.” AdhereTech’s patented “smart bottles” approach compliance from another direction. Somewhat akin to scales at f checkout lane the grocery store selfthat notice if you’ve pulled that twoounce magazine back out of your bag, these vials measure the exact amount of pills or liquid in a bottle in real time and wirelessly send the information to a system that reminds patients to take their medication via automated phone calls or text messages. “If you don’t take the medication after that, the prompts become more insistent. They’ll text, then they’ll call, then maybe they’ll call your mom,” joked Dr. Clauson. “You can control how much you want that to escalate.” AdhereTech recently received funding from Pilot Health NYC, a project of the New York City Economic Development Corporation and Health 2.0, for a trial at Weill Cornell Medical Center, where it will be used to assess patient adherence to an HIV drug regimen over a 12-weekk period and compare it with the usual standard of care. Perhaps the most promising—and the most controversial—drug adherence technology is Helius, the longawaited ingestible biosensor from Proteus Digital Health, which got the green light from the FDA last year after four years of wrangling over exactly how the agency would oversee it. (It was ultimately approved as a de novo medical device because there is no comparable technology on the market.) An “ingestible event monitor” is embedded within a pill a patient takes; that monitor then communicates with a patch worn on the patient’s stomach. “The other devices are proxies—strong proxies, but still proxies,” Dr. Clauson said. “But with a biosensor, you know where and when the patient takes the drug; it also transmits basic

physiologic data as well as drug disposition information. That’s not a proxy, that’s [evidence of ] actual adherence.” Dr. Clauson noted that when the sensor was rolled out in the United Kingdom, it wasn’t piloted through clinics or hospitals. “They partnered with Lloyds, a pharmacy chain, to introduce Helius.” Some pharmacies are working to develop their own remote monitoring tools. Diplomat Specialty Pharmacy, the largest privately owned specialty pharmacy in the United States, is developing an interactive texting tool that uses decision-tree technology to allow automated two-way conversations based on the patient’s responses. Describing how the texting tool works, Gary Rice, RPh, Diplomat’s vice president of clinical services, said, “If you want to validate that a patient took their medication today, you can send them a text asking if they took it. If they did [take it], then you’re done, and the system records that the patient has acknowledged taking their medication. If they say no, they’ll get another text message asking which of five reasons describes why they haven’t taken it.” If, for example, the patient selects “side effects,” the system will ask, “Which of the following side effects are you experiencing?” At some point, the patient can ask to be transferred to a live pharmacist for education on managing that particular side effect; or if the side effects described are severe enough, they may be transferred directly to their physician’s office. Mr. Rice said Diplomat plans to implement this program over the next year “to enhance [their] patient care management program.” The transition of the health care system from a fee-for-service to a “fee-foroutcomes” model, the participatory medicine movement and quantum-leap style advances in technology are converging to jump-start remote monitoring, Dr. Clauson said. “It’s not a wave of the future. It’s quickly becoming a wave of the present.” —Gina Shaw

10 I



Low-Current Brain Stimulation Safe and Effective for Relief of Chronic Pain markets this low-current brain stimulator to video gamers New Orleans—Transcranial direct “These patients had several types of of Medicine, New York City, and a hoping to gain an edge on their current stimulation (tDCS), a noninva- neuropathic and nociceptive pain that co-author of the poster that was pre- opponents. sive technique that is sometimes called failed to be controlled on conserva- sented at the 2013 annual meeting “low-current brain stimulation therapy,” tive therapy and were referred to our of the American Pain Society. “This The study reviewed the experience of is effective in various types of intractable center by pain specialists,” said Zach- retrospective study was conducted 100 patients (45 men and 55 women) chronic pain, according to a review of ary Leuschner, MD, anesthesiology to elucidate patient experience with treated at the Institute for Non-Invasive patient experiences. Brain Stimulation at Beth Israel Medical resident at Albert Einstein College tDCS.” Center in New York City. The institute is one of the few centers in the United States that offer tDCS for the treatment of chronic pain. The institute was established in 2008 within the Department of Pain Medicine and Palliative Care at Beth Israel. Patients in the study were treated with tDCS using either anodal (stimulatory: main electrode placed over the motor cortex) or cathodal (inhibitory: main electrode placed over the somatosensory cortex) between November 2008 and September 2010. Treatment was delivered on five consecutive days in 20-minute sessions. The etiology of chronic pain was neuropathic in 59 patients, nociceptive/somatic in 28 patients, central in six patients, headache in six patients and nociceptive/visceral in one patient. The most common side effect was burning at the electrode site, occurring in 15% of the group treated with anodal tDCS and 20% of those treated with cathodal tDCS. Clinically meaningful pain relief was defined as at least a 30% reduction in a pain score on a numeric pain rating scale from 0 to 10, with 10 being the most severe pain. Overall, after the anodal tDCS treatment, 78% of patients reported pain reduction of more than 30%, and 60% of patients achieved pain relief of greater than 50%. The cathodal tDCS treatment led to pain relief of more than 30% in nearly two-thirds (64%) of patients and pain relief of more than 50% in more than half (53%) of patients. At least 30% pain relief was reported by 44 of 59 patients (76%) in the neuropathic pain group. Among the patients with neuropathic pain, the best responders to tDCS were those with postherpetic neuralgia or complex regional pain syndrome. The effects of pain relief on other parameters were variable. Some patients reduced their use of pain medications; some had improved moods and improved mobility; some had more energy; and some were more tired during initial tDCS sessions.

NOVEMBER 2013 I 11


gases, temperature, non-invasive blood pressure and invasive pressures, and can bullet,” he said. “The insurgents fight to function for at least four hours with acquire them to supplement their blasts. two hot-swappable batteries,” he said. All in all, more people on all sides get The device was designed for the U.S. killed simply as a result of deploying Marine Corps, but Dr. Fisherr said it also these oxygen tanks.” can be used for civilian patient transport More than 10 years of work since his and as a backk up in the ICU in case of a meeting with Mr. Eagles has resulted in surge in demand. the MOVES portable life support sysBradford Winters, PhD, MD, who tem. The 52-pound device requires no has a research interest in patient safety external oxygen source and retains all in the ICU and who was not involved in the critical care and diagnostic func- the development of the new technology, tions of the 180 to 200 pounds of equipment currently used to support and evacuate critically injured patients. Thanks to several gas-conserving strategies, the technology can deliver up to 90% inspired oxygen concentration using only a single internal concentrator. One such approach is a process that Dr. Fisher developed, called sequential rebreathing. “Sequential rebreathing provides an oxygen-rich mix in the initial part of the breath, which is directed to the alveoli, but provides previously exhaled gas in the latter part of the breath, which is distributed predominantly to the gasconductingg tubes that don’t participate in gas exchange,” Dr. Fisher said. The strategy is applied to both spontaneous and mechanical ventilation by an onboard ICU ventilator. “MOVES provides suctioning and full critical care monitoring, including electrocardiography, SpO2, end-tidal CONTINUED FROM PAGE 1

said inter- and intra-hospitall transport “is one of the greatest threats to critically ill patients. MOVES ““seems like a great idea and system,” he said. “On face validity, this device and similar integrated devices would likely improve outcomes and be easier and more effective to carry than two separate ICU devices, but face validity is often wrong when put to the test,” said Dr. Winters, associate professor of anesthesiology and critical care medicine at Johns Hopkins University, in Baltimore.

Dr. Fisher said MOVES underwent human factors, animal and ruggedness tests as well testing in critically ill and postoperative patients, prior to receiving approval from the FDA and the European Union, in 2011. He said Thornhill Research is now filling orders for the Marine Corps and the Singapore Army, and the company is in negotiations with a dozen militaries and rescue organizations for MOVES purchases. —David Wild


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The duration of pain relief also varied, Dr. Leuschner said. “There was interindividual variability over the long term. Some patients reported transient, very short periods of relief, whereas some reported pain relief up to 12 weeks,” he said. Randomized controlled trials of tDCS are currently under way for pain, including postoperative pain, said Roger B. Fillingim, PhD, director of the Pain Research and Intervention Center of Excellence at the University of Florida, in Gainesville, and president of the American Pain Society. A search on the website showed that 18 trials of tDCS in various pain conditions are recruiting, under way or completed. “tDCS is a great example of a pain modality that should be studied [for the] relief of chronic pain. It causes minimal harm, is relatively inexpensive and seems like a feasible approach. [However] reimbursement may be an issue,” Dr. Fillingim said. —Alice Goodman

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12 I



Most Outcomes in Meta-Analysis Favor Off-Pump CABG Miami Beach, Fla.—For patients requiring coronary artery bypass grafts, offf pump surgery may reduce the risk for stroke, renal failure and atrial fibrillation compared with an on-pump procedure, a recent study has found. The meta-analysis of 87 previous randomized controlled trials (RCTs) uncovered no significant differences between the two approaches in rates of all-cause

mortality, myocardial infarction or cardiac reintervention at one year. “However, offf pump bypass surgery instead of conventional bypass surgery may increase the risk for revascularization, especially over the longer term,” said study leader Janet Martin, PharmD, assistant professor of evidence-based medicine and health technology assessment, in the Department of Anesthesia

and Perioperative Medicine, at the University of Western Ontario in London, Ontario, Canada. “And we wonder about an increased risk for mortality over time—and need more evidence to sort that out. “In recent years, there has been f pump bypass renewed interest in offsurgery,” Dr. Martin added. “Purportedly, if we can perform cardiac surgery





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with smaller incisions and less exposure to the coronary pulmonary bypass pump, we should have less invasive surgery and the blood should remain more normal. However, the question is whether or not the evidence supports this.” To find out, she and her associates evaluated 87 relevant RCTs published in the literature, an update to their 2005 systematic review on the same topic (Semin Cardiothorac Vasc Anesth 2005;9:105-111). The new meta-analysis not only included more trials and patients overall (>18,000), but data for high-risk patients, as well. “Thankfully, even in just the past two or three years, we have a number of large randomized controlled trials, and not only in low-riskk patients,” said Dr. Martin, who presented the findings at the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists. The researchers found no significant difference in rates of all-cause mortality between the two forms of bypass: 5.5% with offf pump coronary artery bypass (OPCAB) versus 5.4% for conventional coronary artery bypass (CCAB). “When we look only at midterm to long-term outcome studies, one to eight years, again we find no significant difference in all-cause mortality,” Dr. Martin said. “There was also no material difference between low-risk and high-risk patients [odds ratio (OR), 1.08],” she added. In contrast, patients who underwent OPCAB had a much lower rate of stroke than those who underwent CCAB: 1.9% versus 2.5%, respectively (OR, 0.77). “This is a new finding, and this one really did surprise me,” Dr. Martin said. She found a greater risk for stroke associated with coronary artery bypass graft procedures with fewer grafts. “The stroke [risk] reduction seems to go away in the trials where surgeons performed a lower number of grafts,” she noted. OPCAB also was associated with significantly lower rates of acute renal failure than CCAB (2.1% vs. 2.8%, respectively; OR, 0.78) and need for transfusions (44% vs. 54%, respectively). The researchers also found significantly lower rates of atrial fibrillation associated with OPCAB. Dr. Martin said “for every 37 patients f pump versus on-pump undergoing offbypass, we have one fewer case of postoperative atrial fibrillation.”

NOVEMBER 2013 I 13

PR N In contrast, the rate of repeat revascularizations was higher with offf pump procedures. “Only a few trials report repeat revascularization beyond one year,” Dr. Martin said. “When we looked at them together, there was a significant increase in the risk for revascularization—2.2% versus 1.4% with CCAB.” This means, she added, that for every 125 patients treated offf pump versus on-pump, there will be one more patient who requires revascularization. At this point, it’s not clear whether higher-riskk patients benefit more from offf pump bypass surgery than low-risk patients, Dr. Martin said. “To me that was a surprise,” she said. “It suggests benefits and risks may be equivalent regardless of risk as long as the same number of grafts is performed.” Cost-Effectiveness f pump “We actually found that offbypass surgery—with all the evidence in to balance benefit versus risk—seems to improve patient outcomes as well as reduce overall costs,” Dr. Martin said. She and her colleagues calculated the cost for each complication explored in the meta-analysis based on lifetime probability. “There is some uncertainty around these cost estimates, but the estimates suggest that change in qualityadjusted life-years is a small but positive one and the cost savings are around $76,000 over a lifetime. In our center, in particular, it would be cost-effective if we did more patients using the offf pump approach.” Andrew S. Weisinger, MD, a cardiovascular anesthesiologist at Providence Hospital in Columbia, S.C., suggested the researchers might want to include a third group of patients in future analyses: those who undergo a beating heart surgery without the cross-clamp bypass. For patients in Dr. Weisinger’s practice with poor heart function, the beating heart approach offers multiple advantages, including a “safety net.” For example, because the beating heart patients are already on pump, it is easier to transfer them to a fully on-pump procedure compared with the “crashing on to the heart-lungg machine” required for patients who start out off pump and become ischemic or develop other serious problems. An on-pump strategy also carries advantages for the anesthesia team. “Offf pump surgery is much harder for us and the nurse anesthetists,” Dr. Weisinger told Anesthesiology News. In contrast to a relatively stable onpump bypass in which a phlebotomist f pump monitors blood pressure, an off-

case requires the anesthesia team to more closely monitor blood pressure, ischemia and other clinical parameters, he said. Dr. Weisinger said the surgeon generally chooses the approach for each patient. However, anesthesiologists assist when a surgeon

wants to gauge how well a patient might tolerate the hybrid beating heart/on pump strategy. For example, before committing to a beating heart approach, the surgeon might hold up the heart, position it and ask the anesthesiologist to predict how much intervention will be needed to maintain blood pressure throughout bypass. Assessment of beating heart

surgery to see if aortic manipulation alters these outcomes is worthwhile, Dr. Martin said. “Here’s the catch. A number of studies reported insufficient procedural details, so we could not assign the type of technique they used.” In the future, Dr. Martin said she hopes to expand the meta-analysis to include nonrandomized data and to stratify patients by risk group to facilitate more sophisticated risk factor analysis. —Damian McNamara


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14 I



FDA Makes Opioid Labeling Changes, Requires More Postmarketing Data; REMS Next


he FDA has modified the safety labeling for extended-release (ER) and long-actingg (LA) opioid analgesics, as well as required manufacturers of the agents to conduct more postmarketing studies. Many of the changes reflect requests made in a

petition from Physicians for Responsible Opioid Prescribing (PROP) to limit the prescribing and use of opioids for safety reasons. The drug labeling sections affected by the changes include Dosage and Administration, Warnings and

Precautions, Drug Interactions, Use in Specific Populations and Patient Counseling Information, as well as the Medication Guide. “The labeling changes demonstrate the FDA’s resolve to reduce the serious risks of long-actingg and

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extended-release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,” FDA Commissioner Margaret A. Hamburg, MD, said in a statement. Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said the new labels “describe more clearly the risks and safety concerns associated with ER/ LA opioids and will encourage better, more appropriate prescribing, monitoring and patient counseling practices involving these drugs.” Chief among PROP’s requests was language stating that opioids should not be prescribed for moderate pain. The updated labeling states that ER/LA opioids are indicated “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” In a statement on its website, the FDA stressed the need for individualized treatment for patients with chronic pain, and that the new labeling is designed to help health care professionals reach these goals with each of their patients. “The updated indication further clarifies that, because of the risks of addiction, abuse and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief,” wrote the FDA in the statement. Lynn Webster, MD, president of the American Academy of Pain Medicine, said the reworked indication from moderate to severe pain to pain “severe enough to warrant opioids is more appropriate, as it will take into account factors other than a pain scale score that should be considered when prescribing opioids.” Neonatal Warning Another major addition to the labeling is the inclusion of a boxed warning on the risk for neonatal opioid

NOVEMBER 2013 I 15

PA IN M E D ICIN E More Research, Changes to REMS In addition to the labeling changes, the FDA announced new postmarketing clinical study requirements focusing on “the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.” Dr. Webster called the FDA’s requirement for manufacturers of opioids to conduct long-term safety and efficacy studies “long overdue.” After final labeling is in place, the FDA

PROP Requests Left on Table Andrew Kolodny, MD, president of PROP, tempered his happiness about the labeling changes with frustration regarding changes that were nott made. “We were pleased, but we feel that FDA should have gone much further,” he said. “Their decision to exclude immediate-release opioids is baffling, because all the risks are the same. “We’re disappointed that they didn’t add a suggested maximum duration of use of 90 days and a maximum dosage of 100 mg morphine equivalents. We wanted use beyond these parameters to remain an option for physicians and patients, but we wanted it to be offf label because risks of long-term and high-dose use are likely to outweigh benefits for most chronic pain patients.” Dr. Webster said the labeling changes marked “a good day for people in pain who find opioids helpful. “The FDA did a careful and thoughtful review of the petition presented by PROP and decided there was not enough evidence to support most of the arguments made in the petition,” he said.

intends to revisit the ER/LA opioid analgesics’ Risk Evaluation and Mitigation Strategies (REMS) program that was approved in 2012, “to reflect the updated information.” The current REMS mandates that the manufacturers of ER and LA opioid analgesics provide training for health care professionals who prescribe these agents, as well as educational materials for the health care professionals and for their patients that explain how to safely use the medications. —Donald M. Pizzi


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withdrawal syndrome, associated with chronic use during pregnancy. Dr. Webster praised the FDA’s inclusion of a boxed warning on neonatal opioid withdrawal syndrome, but pointed out a common misconception. “An important positive development was adding a boxed warning that babies born to mothers on opioids may experience opioid withdrawal,” he said. “However, it should be noted that the media has often mischaracterized the withdrawal as a sign the babies are addicted. This is not correct. Babies become physically dependent through their mothers and have to be treated for withdrawal like adults who experience withdrawal. Of course, this is very stressful and a miserable experience for an infant.”  

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16 I



Washington State Pain Clinic Instills ‘Don’t Give Up’ Attitude


ach week, the Rehabilitation Institute of Washington (RIW) pain management team hears patients graduating from its program, say, “Why didn’t I do this years ago?” That’s because many of them, after battling chronic pain for years, have overcome its physical limitations and are doing things they thought they’d never do again. “We see many patients who have completely lost hope that they can improve,” said James Moore, PhD, RIW’s co-founder. “Within a week in our program, they’re more active than they have been in years. This is what keeps us doing what we do.” For more than two decades, RIW’s dedicated team has used an interdisciplinary functional rehabilitation approach to help people with chronic pain restore the physical, emotional, occupational, recreational and social aspects of their lives. “Our experience has been that functional rehabilitation yields better and more lasting changes because patients learn to manage pain and maintain active lifestyles,” Dr. Moore said. Because of its success in treating chronic pain, the Seattle-based, 2011 American Pain Society Clinical Center of Excellence award winner also has become an established Washington State resource on pain and its treatments. Members of the RIW team actively train other physicians, chiropractors, physical therapists (PTs), occupational therapists (OTs), vocational rehabilitation counselors and psychologists, as well as residents, medical students and therapists at the University of Washington and other educational institutions, on how to treat chronic pain. They serve on medical advisory committees for Washington State’s Department of Labor and Industries regarding best practices for managing pain. RIW helped design the state’s pain rehabilitation guidelines and collaborated on developing treatment protocols for complex regional pain syndrome, the use of opioids and detoxifying opioid-dependent patients.

RIW’s current facility is nearly 26,000 square feet, and incorporates an open floor plan. It has three gymnasiums, up-to-date exercise and therapy equipment, the latest computer capabilities and a variety of occupational workstations. “Our new space is not only larger than our old space,” Dr. Kroll said, “but it is laid out in a more efficient way that really maximizes all aspects of patient care.” Becoming an independent clinic also has given RIW much more control over its program. “As part of a large medical center, we had multiple layers of administration, and [the administration] held the decision-makingg power,” Dr. Moore said. “As a freestanding clinic, we’ve been able to expand (three expansions in seven years), design the space to better suit our needs, acquire new equipment, develop new programs, and control the number and composition of our staff. We’ve also given team members more control and decision-makingg power, which in turn has improved morale and provided a sense of ownership of the program.”

Striking Out on Its Own RIW originally was part of a large academic medical center in Seattle. Heather Kroll, MD, RIW’s other co-founder, said the medical center “looked at its finances and goals and what kind of services it wanted to provide, and decided it didn’t want to provide this service.” With encouragement from referring physicians and patients, RIW struck out on its own in 2005, becoming a freestanding pain management clinic and eventually moving into its current location in the uptown, “Lower Queen Anne” section of Seattle. Since then, RIW has nearly tripled its business to almost 700 patients annually. The move proved that the old business axiom about “location, location, location” is true. “The neighborhood we’re in now is less intimidating to patients than the heart of downtown, where the medical center is located,” Dr. Moore explained. “We have plenty of parking and are very accessible to public transportation. Since many patients come from elsewhere in the state, as well as other states, we’ve acquired a nearby apartment building to house patients.”

Getting People Back to Work The bulk of RIW’s patients are injured workers referred for treatment through the state’s workers’ compensation system. “Private health insurance typically doesn’t pay for comprehensive rehabilitation for complex chronic pain problems,” Dr. Moore explained. “Workers’ compensation insurance covers effective treatment because, otherwise, it will end up paying disability for years.” Dealing with Washington’s workers’ compensation system can be challenging, but RIW has learned to navigate it effectively. “We have patient coordinators who take care of getting authorization for treatments and, if necessary, housing and transportation for the workers,” Dr. Kroll said. “Our vocational counselors provide one-on-one counseling on workers’ compensation regulations and help injured workers understand the services to which they are entitled. Our physicians also deal directly with state case managers on the medical issues. It works smoothly because we all have the same priority—getting a person back on the job as quickly as possible.”

RIW physical therapists help patients become stronger, more flexible and more confident so they can resume daily activities.

RIW patients perform job-specific tasks in the institute’s new “work-hardening” program, which simulates the kinds of work activities they might do in their jobs. RIW focuses on active, exercise-based physical therapy to improve strength, endurance, flexibility, posture and body mechanics. The program stresses occupational therapy to advance physical activity and daily function; psychological counseling to promote coping strategies and the emotional sequelae of pain; medical management to educate patients about pain and minimize the use of harmful or dependencecausingg medications; and vocational counseling to help patients return to productive employment. The institute also provides nutrition counseling and drug detoxification services. A patient arriving at RIW will undergo an intenf dayy evaluation with a physician, pain psysive halfchologist and vocational rehabilitation counselor. On entering RIW’s program, patients spend the next 20 days, Monday through Friday, from 9 a.m. to 4 p.m., working with rehabilitation specialists to restore function, improve cardiovascular health and learn proper body mechanics and coping strategies. Physical therapy may include gait training, flexibility exercises, spinal stabilization exercises, postural exercises, neuromuscular retraining, strength training, cardiovascular exercise and more. Occupational therapy focuses on job-specific work, home or leisure activities, such as how to sit and

NOVEMBER 2013 I 17


Increased Risk for SSI Seen in Patients With Myelopathy or Spinal Cord Injury Mont Tremblant, Quebec— Patients who have myelopathy or a spinal cord injury are much more likely to develop a surgical site infection (SSI), according to an administrative database study of posterior cervical spine surgery. Patients who are aged 50 years or older also are associated with a small but significantly elevated risk for an SSI. The researchers extracted data from the Nationwide Inpatient Sample on inpatients who underwent surgery between 2000 and 2009, and compared groups with radiculopathy with or without myelopathy, and traumatic cervical injury with or without a neurologic injury. The team, from Vancouver, Canada, and Philadelphia, presented the results at the Canadian Spine Society’s 2013 annual meeting. “The thought is that when looking at rates of concurrent neurologic dysfunction in such a large cohort, the effect

is probably real rather than confounding,” said lead investigator Ravi Ghag, MD, a fifth-year orthopedics resident at the University of British Columbia, in Vancouver. He and his co-investigators identified 1,762,277 patients, of whom 1,389,763 had radiculopathy and 52,979 had a traumatic cervical injury. Among the radiculopathy patients, 372,514 (26.8%) had concurrent myelopathy, and 15,034 (28.4%) of the traumatic patients had concurrent neurologic injury. Patients with concurrent myelopathy and those with concurrent neurologic injury were significantly older, and more were men, than the other patients in their respective groups (P<0.001 for both). Furthermore, there was a higher proportion of black, Asian and Hispanic individuals in the myelopathy group.

Bivariate analysis revealed that 0.58% of patients with radiculopathy without myelopathy developed SSIs, compared with 1.35% among those with radiculopathy and myelopathy (P<0.001) (Table). Multivariate regression analysis revealed that patients with radiculopathy and myelopathy were 1.82 times more likely to develop an SSI than were patients without myelopathy (P<0.001). Patients with a traumatic cervical injury and concomitant neurologic injury were 1.33 more likely to have an SSI than were those without a neurologic injury (P=0.07). Fusion of two or three vertebral levels among patients with trauma was protective compared with fusion of four to eight vertebral levels (odds ratio [OR], 0.49; P<0.001). Older patients with radiculopathy had a higher risk for SSI than younger

Table. Bivariate Analysis of Outcome Variablesa Parameter

Radiculopathy Without Myelopathy

Radiculopathy With Myelopathy

Trauma Without Spinal Cord Injury

Trauma With Spinal Cord Injury

SSIs, %





Mean length of stay, days (interquartile range)

1 (1-2)

2 (2-4)

6 (3-10)

9 (9-15)

Unadjusted cost in 2010 US$ (interquartile range)

$27,840 ($18,900-$34,970)

$36,680 ($23,650-$49,920)

$66,730 ($40,430-$118,500)

$84,370 ($49,110-$158,100)

SSIs, surgical site infections a

Comparisons Co pa p so s bet between ee radiculopathy ad cu opat p y without t outt myelopathy yye opat p y and a d with t myelopathy, yye opat p y, and a d between beet ee trauma t au a without t out spinal spp a cord co d injury jju y and a d with t sp spinal p a co cordd injury; jju y; P value a ue PP<0.001 <0 00 for o bot both.

patients (OR, 1.03; P<0.001), whereas female gender was protective against SSI (OR, 0.61; P<0.001). The investigators said using an administrative database resulted in underestimating the rate of complications in all patients. This method also did not allow analysis of factors known to affect the rate of SSIs, such as diabetes, intraoperative irrigation, duration of surgery, patient age, body mass index, smoking history, length of preoperative hospital stay and antimicrobial prophylaxis. “I have used several administrative databases myself for research and also find that complications tend to be underreported,” said Keith Baldwin, MD, MSPT, MPH, assistant professor of orthopedic surgery at the Children’s Hospital of Philadelphia, who was not involved in the study. “Also, the followup for these databases is generally too short to determine the true rate and cost of infections, and as such the true infection rate is likely higher than reported. But there is no reason to suspect that the data are differentially biased with respect to neurologic damP values are likely to age. As such their P be correct, even if their exact percentages and odds ratios are not.” —Rosemary Frei Dr. Baldwin is a consultant for Synthes Trauma and a stockholder in Pfizer.


stand comfortably, lift and carry things, walk, climb stairs, and use arms and hands. The program puts a strong emphasis on the nonphysical or psychological aspects of the pain experience. “The core psychological focus is to help patients understand that their pain might not be dangerous, and it should not affect daily activities,” said David Fordyce, PhD, an RIW psychologist. “We also deal with the myth that seeing a psychologist means their pain is imaginary. It is a worry many patients carry. We try to make them understand that their pain is absolutely real.” Dr. Fordyce estimated that nearly 80% of RIW’s patients are dealing with psychological issues. Their biggest concern: fear of their pain and an almost phobic anxiety that it will get worse, or they will reinjure themselves if they try to do something. To help patients overcome these fears, RIW’s pain psychologists not only offer cognitive and behavioral coping skills for managing fear, depression, anger and other emotional consequences of pain, but help patients understand the very nature of chronic pain and how it affects them and their families.

Dr. Fordyce pointed out that the psychological component of the program does not act independently of the physical and occupational rehabilitation, but rather is complementary. “The psychology is kind of the icing on a cake that supports our physical rehab,” he said. “Our PTs and OTs are often our strongest psychologists, because their job is to stand next to a patient who is very fearful, anxious and frustrated at being asked to do something physical in the face of his or her pain. So, from the moment a person walks in the door, the PTs and OTs tell them they know it will be difficult and scary, but they are going to support the patients in slowly moving their bodies. It will be OK.” Although the PTs and OTs spend the most oneon-one time with patients, RIW’s physicians and psychologists are frequently in the gyms, helping patients overcome any anxiety about what’s happening to their bodies. According to Dr. Kroll, this kind of teamwork and concern for patients, along with the experience see RIW page 21


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18 I



Ondansetron May Inhibit Analgesic Effect of Acetaminophen


ndansetron may inhibit the analgesic effect of acetaminophen when the two drugs are co-administered, Canadian researchers have found. The recent study looked at children who received either ondansetron or droperidol in conjunction with acetaminophen during tonsillectomy surgery. â&#x20AC;&#x153;Children who received the two drugs together needed more morphine in the recovery room after the operation,â&#x20AC;? said Pierre Beaulieu, MD, PhD, associate professor of anesthesiology and pharmacology at the University of Montreal. â&#x20AC;&#x153;Based on our findings, we think the coadministration of these two drugs is deleterious for pain relief.â&#x20AC;? The researchers were scheduled to present their findings at the 2013 annual meeting of the Canadian Anesthesiologistsâ&#x20AC;&#x2122; Society (abstract 1652406), but the conference was cancelled because of severe flooding. Dr. Beaulieu said his study confirms that acetaminophen and ondansetron engage the same serotonin (5-HT3) receptor. â&#x20AC;&#x153;Because acetaminophen and ondansetron are working on the same receptor, when they are administered together, there is a decrease in pain relief,â&#x20AC;? he said. Previous research demonstrated the inhibitory effect of ondansetron on acetaminophen in animal and human volunteer studies, but relevant clinical trials in humans had failed to show an effect. Dr. Beaulieu and his colleagues designed a double-blind parallel group study of 69 children, ages 2 to 7, who underwent elective tonsillectomy and received acetaminophen as an analgesic. The researchers randomly assigned the patients to receive either ondansetron (n=35) or droperidol (n=34) as an antiemetic. The investigators assessed the childrenâ&#x20AC;&#x2122;s pain and morphine consumption for 48 hours after surgery. There was no difference in postoperative nausea and vomiting (PONV) between the two groups, and the primary end pointâ&#x20AC;&#x201D;postoperative painâ&#x20AC;&#x201D; did not differ significantly between the two groups during the first 24 hours. Children who received ondansetron, however, were 2.8 times more likely to require morphine (57.1% vs. 20.6%). The amount of morphine administered to the ondansetron group was nearly three times more (279.5 vs. 97.6 mcg) than to children who received droperidol (Figure).

Dr. Beaulieuâ&#x20AC;&#x2122;s conclusions, however, are controversial. Sergio Bergese, MD, chief of neuroanesthesia at Ohio State University, in Columbus, and Suren Soghomonyan, MD, PhD, a research scientist at Ohio State, noted that the study did not include factorial controls, and therefore could not demonstrate a clear interaction. â&#x20AC;&#x153;Increasing numbers of patients receive acetaminophen

and ondansetron in combination postoperatively to treat pain and reduce the incidence of PONV. Undoubtedly, clinically important interaction between those drugs, if any, would deserve further research and might have impact on clinical practice,â&#x20AC;? Dr. Bergese said. â&#x20AC;&#x153;However, in vitro, in vivo and clinical studies specifically designed to test the hypothesis of drug


interaction are mandatory before making any conclusions. Any single clinical trial, especially when underpowered in regard of the specific objective, will be inconclusive.â&#x20AC;? Furthermore, he stated, droperidol is a sedative and increases opioid effects, which would decrease total opioid consumption. The study may have been further complicated by the





NOVEMBER 2013 I 19

nursesâ&#x20AC;&#x2122; interpretation of the patientsâ&#x20AC;&#x2122; need for additional morphine. â&#x20AC;&#x153;The sedative effect of droperidol could easily influence the nursesâ&#x20AC;&#x2122; perception of patient pain,â&#x20AC;? he said. Dr. Bergese also pointed out that acetaminophen may act on the 5-HT mechanisms primarily via the 5-HT7 receptors, whereas ondansetron is a selective

On Off

Morphone titration (in Îźg)




500 279 250 97.6 0

Ondansetron group

Droperidol group

Figure. Morphine titration in the recovery room expressed as median and interquartile range (box) (P= P 0.01)

5-HT3 antagonist. In addition, endocannabinoid and opioid systems are major components of the antinociceptive activity of acetaminophenâ&#x20AC;&#x201D;and these systems are not engaged by ondansetron. â&#x20AC;&#x153;The overall picture in a clinical setting is more complex,â&#x20AC;? Dr. Bergese said. â&#x20AC;&#x153;Attempts to explain the cumulative effects of two drugs based on the assumption that these

when you want it. when you donâ&#x20AC;&#x2122;t.

Anesthesia providers identiďŹ ed more than 150 procedures for Remi*.1 Providers interviewed recommend Remi for more than 150 procedures.1 Where could Remi beneďŹ t your practice?







Remi gives you predictable control of depth and duration of analgesia when you need it most2 t Rapid onset of 1 to 2 minutes2 t Rapid response to dose adjustment within 5 to 10 minutes2 t Rapid offset within 5 to 10 minutes results in rapid dissipation of effect and rapid recovery2 t Unique organ-independent metabolism provides rapid elimination with no accumulation2

Visit to see where Remi could work for you. Please see Indications and Important Risk Information below and accompanying brief summary of Prescribing Information on next page for all precautions, warnings, contraindications, and adverse events.


%VFUPUIFQSFTFODFPGHMZDJOFJOUIFGPSNVMBUJPO ULTIVA is contraindicated for FQJEVSBMPSJOUSBUIFDBMBENJOJTUSBUJPO6-5*7"JTBMTPDPOUSBJOEJDBUFEJOQBUJFOUT XJUILOPXOIZQFSTFOTJUJWJUZUPGFOUBOZMBOBMPHT 6-5*7"4)06-%#&64&%*/5)&$"3&'6--:.0/*503&%4&55*/(#: 41&$*'*$"--:53"*/&%1&340/4/05*/70-7&%*/5)&463(*$"-03 %*"(/045*$130$&%63&09:(&/4"563"5*0/*450#&$0/5*/6064-: .0/*503&%3&464$*5"5*7&"/%*/56#"5*0/&26*1.&/5 09:(&/  "/%"/01*0*%"/5"(0/*45.645#&3&"%*-:"7"*-"#-& 3FNJGFOUBOJMJTDPNNPOMZSFGFSSFEUPBT3FNJCZBOFTUIFTJBQSPWJEFST References: 1. Data on ďŹ le. Canonsburg, PA: Mylan Institutional; 2012. 2. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.

drugs interact on a single receptor level is over-simplification.â&#x20AC;? For Dr. Beaulieu, the question is not settled. â&#x20AC;&#x153;We now need to design a large-scale study, ideally multicenter, to determine whether there is an interaction in a larger population,â&#x20AC;? he said. â&#x20AC;&#x153;If we confirm the interaction, we should change our practice and not give the two drugs together, and that will affect millions of people around the world undergoing surgery.â&#x20AC;? â&#x20AC;&#x201D;Keely Savoie

20 I



Health Care Practitioners Benefit From Using Opioid Rx Guidelines Fort Lauderdale, Fla.—When prescribing opioids, pain physicians and nurse practitioners may need further education to meet a state’s guidelines. For example, researchers have suggested that these health care providers review their panel of patients to

ULTIVA® for Injection

ensure polypharmacy is appropriate. “In Utah, our medical examiner raised concerns that the state had a high rate of opioid-related deaths,” said Brian C. Sauer, PhD, MS, assistant professor of internal medicine at the University of Utah School of Medicine,

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits

in Salt Lake City. “Initial epidemiological analysis led by Christy Porucznik, PhD, confirmed the medical examiner’s concerns. As a result, Robert Rolfs, MD, the state epidemiologist, led the development of the Utah clinical guidelines on prescribing opioids,”

and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045

Dr. Sauer said. Drs. Sauer, Porucznik and Rolfs received funding to examine the effect of opioid prescribing guidelines on practice, the rate of guideline violations by clinical specialty and the effects of an intensive educational intervention on those violations. To quantify the extent to which clinical specialty affects the proportion of chronic opioid users who experienced unsafe prescribing (as outlined in the Utah Opioid Prescribing Guidelines), Dr. Sauer and his colleagues used the Utah Controlled Substances Database for patient- and provider-level prescribing data. The researchers flagged the dual use of long-actingg opioids (LAOs) and combined use of benzodiazepines and LAOs. Opioid use was categorized as acute, intermittent, chronic or palliative. Records were analyzed for a 12-month period between April 2009 and March 2010. Speaking at the 2013 annual meeting of the American Academy of Pain Medicine (abstract 165), Dr. Sauer said that 36,364 patients who were classified as chronic users received opioids during the study period. LAOs were dispensed for 16,618 of these patients. Providers were involved in 953 long-acting polypharmacy flags and 8,198 LAOs and benzodiazepine flags. Pain medicine physicians (12%) and nurse practitioners (11%) had the highest proportion of chronic pain patients with LAOs flags. “As it turns out, the group you would most likely expect to see potentially difficult patients—the pain physicians— had a higher rate for some of these flags,” Dr. Sauerr said. “Nurse practitioners, too, since they can prescribe without oversight of a physician in the state of Utah.” Dr. Sauer found such prescribing violations could be curbed with educational interventions. “We went around the state and educated providers on how to use the guidelines and the tools for making use of them,” he said. “And we showed that when a state puts a lot of energy into educating physicians, there’s a change in these prescribing habits,” he added. “When we looked at the groups that went to at least one intensive educational session versus those who didn’t, we saw that the groups that went to the intervention had improvements in a couple of areas of possible prescribing violations,” Dr. Sauer said. A decrease in opioid-related deaths also was observed in practitioners who participated in educational initiatives. Practitioners’ efforts to curb prescribing violations also were boosted

NOVEMBER 2013 I 21



the team has acquired over the years, makes the program successful. “Many of our patients have had lots of physical therapy, and it hasn’t helped,” she said. “Our staff reassures them it is safe to move, and [explains to them the] kind of symptoms they should pay attention to and which ones to ignore. Our team is very good at handling questions and negotiating a patient’s fear.” Measurable Improvements Since becoming a freestanding pain clinic, RIW has posted impressive outcomes. For example, for patients who completed the program in 2010, more than 72% returned to work by one-year follow-up, and another 12% were in retraining, according to the clinic. Patients improved in all measures— reported pain, pain worry, fear avoidance beliefs, depression, selff reported

by the support of professional organizations, Dr. Sauer said. “I think that having state- and professional organization–sponsored guidelines on how to use opioids for chronic pain management provides support and a reference for physicians to communicate and justify their decisions when patients request therapies or combinations the provider may not be comfortable using,” Dr. Sauer said. Leonard J. Paulozzi, MD, MPH, a medical epidemiologist with the Centers for Disease Control and Prevention, in Atlanta, said a number of epidemiologic studies have shown similar results. And although guidelines certainly help practitioners to prescribe responsibly, prescription drug monitoring programs (PDMPs) have made it more challenging for patients who know how to work the system. “Particularly in modern health care in the U.S.—where a patient might see a family physician for one thing, a specialist for another and a psychiatrist for something else—people may have access to multiple prescriptions from multiple providers,” Dr. Paulozzi said. “We don’t have a national health system where a physician can look up a patient’s health claims and see all their prescriptions, so we need some other source of information that will offer a person’s history with controlled substances,” Dr. Paulozzi added. “And that’s what PDMPs are designed to do.” —Michael Vlessides

function and objective measures of function. Patients also had reduced use of opiates, sedatives, alcohol and tobacco. And they reported that after leaving the program, their newly learned coping strategies keep them more active and independent at home. RIW’s newest initiative is its “workk hardening” facility, where patients can simulate the kind of work they might do in a job, such as moving freight, running power tools or climbing ladders.

“We hope to grow this program to help injured workers return to jobs that require the performance of specific work tasks and high levels of fitness and endurance,” Dr. Moore said. The institute strives to help physicians understand that its program is effective for treating anyone with chronic pain, excessive medication use and prolonged disability. “We’d like to be able to treat patients sooner, before they undergo unnecessary surgery, become dependent on

medications, or become depressed and hopeless about returning to work,” Dr. Moore continued. “We have an evidence-based treatment approach that is as effective as more invasive treatments, but less costly and less likely to result in medical complications. We hope to educate physicians about the availability of this approach, and thus provide effective care to a larger group of people with chronic pain.” —Tom McDonough

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22 I



ASA Cuts Ties With Subspecialty Groups

is over, everyone has to run to their own homes. “I don’t think anything will be difoverwhelmingly in favor—thought an ferent, except perhaps a more positive Weaning process proves tough for some, boon for others intact but dysfunctional family was relationship with the subspecialties,” he American Society of AnesSeveral people affected by the deci- better than a split one. Dr. Zerwas said. The decision to sever thesiologists admits that one sion likened it to a change in the famJohn Zerwas, MD, immediate past- administrative ties “was better. The task it doesn’t handle very well ily situation: a divorce, a parent urging president of the ASA, said the organi- subspecialty societies were often is managing the affairs of its several a grown child to leave home and make zation still can and will team up with unhappy with the service that the ASA subspecialty organizations. So earlier it on his own, or a child insisting he the satellite groups, as is expected at was providing.” The weaning has been painful this year, the ASA decided to give up still needs the nurturing that can only Anesthesiology 2013, which in this the job, forcing the groups to scramble be found in the ASA nest. The few case is the profession’s Thanksgiving. for some subspecialty groups, but opponents of the move—the vote was It’s just that after the family gathering some feel they may be better off. to outsource their management. Dr. Zerwas said the ASA had been managing many of the subspecialty organizations since the early 1990s, maintaining crucial housekeeping activities like updating their membership databases, arranging meetings, publishing newsletters and collecting fees.


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Frayed Family Ties Yet, few were happy with the ASA’s performance. “Most of what it does, it does very well,” said Barbara Scavone, MD, president of the Society for Obstetric Anesthesia and Perinatology. But she added, “The ASA was not a very good management company. I think they were trying to do it in a very cost-effective way, but you get what you pay for. They weren’t giving us the service we needed. They knew it; we knew it.” “The ASA is a very clunky organization,” said Nancy L. Glass, MD, president of the Society for Pediatric Anesthesia. Dr. Zerwas pleaded guilty to Dr. Scavone’s charge. However, he added that the ASA’s core mission is to advance the science and practice of anesthesia, both in general and for specialists. “The thing we really wanted to nurture and develop was being compromised by this constant sort of dissatisfaction with various money issues and management issues,” Dr. Zerwas said. “The ASA was unable to retain quality staff to do this work. We found ourselves in a constant manpower turnover situation.” The decision to cut off managing the subspecialties came as no surprise. The ASA’s board of directors had been mulling it for the past two years, said Scott Groudine, MD, a board member from Albany, N.Y. Dr. Groudine was one of the few dissidents regarding the move. “I didn’t want a divorce,” he said. “I wanted to stay married to them.” Some of the larger, more established subspecialties were already managing themselves. His fear was that the smaller subspecialties

NOVEMBER 2013 I 23

POL ICY & M A N A G E ME N T the added expense of cost was 50% lower—and the group ASA benefits from having subspecialty would suffer from the change, and that memfarming out the duties gets more attention. But Dr. Eappen, groups, as well as vice versa. But leaving to outside manage- like others, wonders whether the tran- the ASA’s “complex” financial accountbership would dwindle ment firms, including sition will affect the group’s relation- ing system “in some ways, might be libbefore they could get established themselves. Ruggles Services Corp., ship with the mother association. “Is erating for smaller societies.” The basis for the based in Richmond, the ASA going to hear our voice?” he Dr. Eappen said he fears a declining decision was in large Va. The company did asked. “We worry about that.” relationship between the satellite socipart financial, as man-not respond to a request n The transition “has been pain- eties and the ASA with the new managing the subspecialtiies forr comment. ful,” said Alan Marco, MD, president agement system. “I think that we lost cost “well into the six figures,” However, Sunil Eappen, MD, of the Society for Ambulatory Anes- something when we lost that connecDr. Groudine said. president of the 225-member Asso- thesia, but “our group is faring quite tion,” he said. “The ASA was collectively subsidiz- ciation of Anesthesia Clinical Direc- well.” Dr. Marco said he does not —John Dillon ing the subspecialties at a significant tors, said that much to his surprise, the expect any change in fees. He said the level,” Dr. Zerwas said. “To add more people to continue to provide the service would have been a cost borne by the entirety of the ASA.” ® But Dr. Groudine said the ASA could afford to keep the smaller subMake Your Video Laryngoscope a System! specialties afloat. “There are a lot of teenagers who could use a little subA Single Instrument is not Airway Management sidy,” he said. “Nobody’s born an adult. It seemed like the ASA was a good incubator.” Dr. Groudine predicted that the membership fees would rise for individual subspecialty groups because of


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Limited-Calorie Diet May Have Same Benefits as Eucaloric in IC


new study suggests that a limited-calorie diet may offer just as much benefit as the standard eucaloric diet to patients requiring nutritional support in a surgical intensive care unit (SICU). A handful of small studies have shown that some critically ill patients, including obese patients and those with multiple traumas, may benefit from permissive underfeeding (Ann ( Surg 1992;215:503-511). The latest study is the first randomized controlled trial to examine the benefits of low-calorie feeding in SICU patients. The research, presented at the 2013 annual meeting of the Surgical Infection Society, found that the eucaloric diet was no better at preventing infections, reducing patients’ lenghts of stay (LOS) in the ICU or hospital or maintaining glucose control than hypocaloric feeding in SICU patients. The study also demonstrated no

survival benefit for the eucaloric diet. Lead author Eric Charles, MD, a general surgery resident at the University of Virginia, in Charlottesville, said the study suggests the eucaloric diet, the current gold standard for SICU patients, might not be ideal for critically ill patients. “In fact, less may be better. If not better, then patients are likely not harmed if they do not receive their full daily calculated amount of calories,” said Dr. Charles. The randomized, single-institution study was conducted at the University of Virginia. Investigators randomized 84 adult patients to receive a eucaloric diet of 25 to 30 kcal/kg per day (n=42) or a hypocaloric diet of 12.5 to 15 kcal/kg per day (n=42). Patients on both diets received 1.5 g/kg of protein each day. All patients were admitted to the SICU and deemed appropriate for nutritional support.




The primary outcomes of the study were the presence of infection, the number of infections per patient, the infection site and the causative organism. Secondary outcomes included a measurement at 6 a.m. of blood glucose levels, insulin requirements, ICU and hospital LOS, and in-hospital mortality. Analysis revealed no difference in any of the primary or secondary outcomes. The study did not examine the potential economic advantages or time-savingg benefits for either diet. Current guidelines call for critically ill patients to receive 25 to 30 kcal/kg per day with 1.5 g/kg of protein. Nutrition should be initiated 24 to 48 hours from admission with the goal of providing at least 50% to 65% of calories to achieve clinical benefit. But results from this study suggest otherwise. “Maybe the goal should be different,” said William G. Cheadle, MD, professor of surgery at the University of Louisville, in Kentucky. When patients receive nutritional feeding, they are at increased risk for

aspiration of tube feeds feeds; diarrhea for enteral feeds; and infection, fluid overload, hyperglycemia and central line complications for parenteral nutrition, he said. “These risks are lessened if the amount of calories needed were less than the traditional amounts. Thus, this study shows that feeding less in the ICU may be better, as overall morbidity was the same,” Dr. Cheadle said. The study could not identify optimal caloric amounts for patients in the SICU, Dr. Charles stressed. The researchers are currently setting up a large multicenter randomized trial to compare the two diets. “Right now, we have data that show there is no benefit or risk to hypocaloric feeding. There are no advantages that we know of at this time for patients receiving as many calories as they do,” Dr. Charles said. “We have shown no difference between standard amounts and 50% of that value.” —Christina Frangou

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Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer. Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery. This activity is jointly sponsored by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade. Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next? 2. What potential postoperative risks does this patient face?

Access this activity at

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risk [RR], 0.73; P=0.001) but increased the risk for stroke (RR, 1.73; P=0.05) and hypotension (RR, 1.51; P<0.00001). Meanwhile, U.S. and European cardiology guidelines released in 2009 recommend this therapy, and the study authors say it’s time for an update. Those guidelines were based largely on the series of DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) studies that reported various cardiac benefits from the use of perioperative β-blockers. DECREASE I found that perioperative bisoprolol reduced short- and long-term cardiac death and MI; a follow-up DECREASE IV found that bisoprolol also significantly reduced 30-day cardiac death and MI in intermediate-riskk patients. Then, in 2011, the studies’ principal investigator, Don Poldermans, MD, PhD, was fired from Erasmus Medical Center in Rotterdam, after an investigation found him guilty of scientific misconduct, including failure to obtain patient consent and logging results that did not match patient medical records. A medical center investigation found that the events in DECREASE IV did not match patients’ medical records, and at least one of the DECREASE trials reported almost entirely fictitious data, according to Darrel P. Francis, MD, professor of cardiology at Imperial College’s National Heart and Lung Institute and the senior author of the new study. Dr. Poldermans resigned from the European Society of Cardiology’s (ESC) Committee for Practice Guidelines. But because the papers have not been retracted from medical journals, the guidelines have remained, leaving clinicians confused about what to do. “I used to feel so reassured recommending perioperative β-blockade,” Dr. Francis said. “It seemed a fantastic solution to a difficult problem.” But now Dr. Francis recommends the therapy mainly for patients with a high risk for MI who must undergo surgery. He suggested that other clinicians review the paper and guidelines to make an informed decision. Earlier Signs of Trouble The benefits of perioperative β-blocker therapy have been questioned in previous studies, such as the PeriOperative ISchemic Evaluation (POISE) trial and another meta-analysis by researchers at Brigham and Women’s Hospital, in Boston, both published in the Lancet in 2008 (371:1839-1847; 1962-1976). But it was the POISE study—included in the current study’s analysis—that served as perhaps the strongest initial salvo against perioperative β-blocker therapy. The study compared extended-release metoprolol with placebo in 8,351 patients with atherosclerosis or at risk for the condition. Patients were given the drug between two and four hours before surgery and took it for 30 days after their operations. As expected, fewer patients who received metoprolol had an MI during the study period (4.2% vs. 5.7%; P=0.0017). However, patients given the β-blocker were significantly more likely to have a stroke (41 vs. 19; P=0.0053) or to die (129 vs. 97; P=0.0317) during the 30 days of follow-up. The bottom line, according to the researchers: For every 1,000 patients given metoprolol for noncardiac surgery, 15 would avoid an MI but five would

0.98 have a stroke and eight would 0.97 die. In addition, although 0.96 β-blocker therapy would pre0.95 vent some cases of atrial 0.94 fibrillation and cardiac revas0.93 cularization, it would lead to 0.92 nearly 100 cases of clinically 0.91 relevant hypotension and bra0.90 dycardia for every 1,000 people 0.89 who received the drug. 0 5 10 15 20 25 30 POISE co-principal investigaTime to Major Cardiovascular Complication (days) tor Homer Yang, MD, professor N Number b at risk: i k 3,571 3,530 3,515 3,506 3,500 3,494 and former chair of anesthesiol- — 3,736 ogy at the University of Ottawa, — 438 401 397 393 391 390 389 in Canada, said the new study — 3,729 3,606 3,572 3,558 3,550 3,539 3,533 findings are consistent with — 407 401 398 395 393 392 440 POISE. “Even in our paper, we stated that people need to be Figure. Event-free survival curves for cardiac complications by careful with patients and not surgical urgency and treatment assignment. use β-blockers as ‘holy water’ for Reprinted with permission from Homer Yang, MD. everyone,” he said. Dr. Yangg said including anemia, blood transfusion, emergent surgery he still recommends ß-blockers in the perioperative setting, “but not in the low-risk and pre-existingg cerebrovascular disease. “It is imporpatient population—that’s where the risk–benefit ratio tant for us to figure out how to use these drugs safely. comes in. Irrespective of starting β-blockers anew, as was done “We have always taken a balanced approach,” he in these studies, 20% to 40% of surgical patients are added. “We don’t want to [characterize] β-blockers as chronically taking β-blockers. Recent evidence sugevil or permanently condemned. Medicine just isn’t gests that these patients also have [an] increased numlike that.” ber of strokes.” POISE used “industrial dosages of β-blockers that Dr. Yangg and others are trying to tease out which most of us would never use,” said Kim Eagle, MD, the patients might benefit—or be harmed—the most A. Walter Hewlett Professor of Internal Medicine and from perioperative β-blocker therapy. One hypothedirector of the Cardiovascular Center at the Univer- sis is that patients treated during emergency surgery sity of Michigan, in Ann Arbor, but the current study might not benefit as much as those with sched“does call into question how much value versus harm” uled surgeries. “Emergency surgery has always been they offer. Dr. Yangg replied that the seemingly high known to be a higher-risk setting,” Dr. Yangg said. (100 mg) doses of slow-release, once-dailyy metopro- “In a subgroup analysis [of POISE] … the survival lol metabolize in the body was similar to thrice-daily curves of patients getting metoprolol versus controls lower doses (25 mg) of immediate-release metoprolol. in emergency surgery do not separate as nicely as the The current meta-analysis also explained that, stating elective cases.” “the POISE trial was therefore not high-dose.” He also speculated that “emergent cases possibly are already bleeding more or already have more hypotenA Balanced Approach sion, which was identified in our POISE study as risk Other physicians also continue to use β-blockers factors for worse outcomes. Additionally, β-blockers for perioperative purposes but are doing so more judi- reduce the reserve in cardiac output responses, and so ciously. Dr. Eagle said β-blockers are indicated “for those risk factors in emergency surgery may be exacpatients with established coronary artery disease and erbated by the use of β-blockers. That’s a hypothesis— ischemia based on symptoms or non-invasive testing, we can’t prove it yet.” Thus, more clinical trials focusing on β-blocker for whom no contraindications exist, and where the dose is carefully titrated so as to avoid undue brady- safety are “urgently required,” Dr. Yangg added. One cardia and or hypotension. They would be especially early clue has already emerged: A study he was schedindicated for patients having major vascular surgery.” If uled to present at the Canadian Anesthesiologists’ they are used, they should be started at low doses “and Society meeting this summer—the meeting was cannever pushed to the expense of low blood pressure,” he celled because of flooding—showed no significant difsaid. “We have to be circumspect in how we dose the ference between the two groups of patients. He said he medicines because they can cause harm.” is still analyzing those data (abstract 1653709; Figure). The American College of Cardiology, the AmerW. Scott Beattie, MD, PhD, the R. Fraser Elliott Chair in Cardiac Anesthesia at the University Health ican Heart Association and the ESC are all in the Network in Toronto, Ontario, Canada, said the cur- process of completing updated guidelines for perirent findings are similar to previous meta-analyses. operative cardiac management, according to a state“Lost in the ‘controversy’ is that β-blockers do exactly ment on ESC’s website. “In the interim, our current what we thought they would—reduce periopera- joint position is that the initiation of β-blockers tive MI,” he said. “We need to ask: If the risk of heart in patients who will undergo non-cardiac surgery attack, the leading cause of postoperative mortality, is should not be considered routine, but should be conlowered, why are more patients dying?” The POISE sidered carefully by each patient’s treating physician data, Dr. Beattie noted, identified potential safety on a case-by-case basis.” issues that may be contributing to that excess mortality, —Karen Blum

Event-free Survival


— Elective Surgery + Placebo — Emergent Surgery + Placebo — Elective Surgery + Metoprolol — Emergent Surgery + Metoprolol

NOVEMBER 2013 I 27


Walk This Way: Adductor Block After TKA Aids Ambulation Boston—Compared with continuous femoral nerve blocks, continuous adductor canal blocks may allow patients to walk greater distances immediately after knee replacement surgery, new research suggests. The case–control study, of 45 patients undergoing total knee arthroplasty (TKA), found that those who received continuous adductor canal blocks walked an average of four times as far as those who received continuous femoral nerve blocks. “We did not identify any reduction in analgesia or increased opioids,” said Justin Workman, MD, regional anesthesia and acute pain medicine fellow at Stanford University School of Medicine, in California. He presented the findings at the 2013 spring meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA; abstract 57). The two groups had similar lengths of stay in the hospital. Although commonly used after TKA, femoral nerve blocks can cause quadriceps weakness that can increase the incidence of patient falls and hinder physical therapy. Several nerves that innervate the knee traverse the adductor canal, and blocking this canal involves little motor activity. This canal, therefore, offers a more distal site for insertion of a perineural catheter, and may help spare motor function of the quadriceps muscle without reducing pain relief. Previous research demonstrated that adductor canal blocks are effective at providing analgesia after knee surgery (Anesthesiology 2013;118:409-415). Little is known, however, about the effects of continuous adductor canal blocks on functional outcomes. To fill this gap, researchers retrospectively reviewed the records of all patients who had a primary TKA at the Palo Alto VA. In March 2012, the VA replaced femoral nerve catheters with adductor canal catheters as part of a clinical pathway, making it standard procedure. The investigators compared

outcomes in patients six months before and six months after the institution made this change. Other aspects of the clinical pathway, including PT, nursing care and use of analgesics, remained the same. The investigators excluded patients who had additional, significant surgeries. After further narrowing the patient groups by including only cases

that were performed by one surgeon and patients who were admitted to the primary surgical ward postoperatively, 21 patients comprised the group that received femoral nerve blocks and 24 patients were in the group that received adductor canal blocks. Baseline characteristics including age, sex, American Society of Anesthesiologists physical status, height, weight and

body mass index were identical or similar in the two study arms. The median maximum ambulation distance on the day after surgery, the primary outcome, was greater in patients receiving the adductor canal blocks (24 vs. 6 meters; P=0.023). The average length of stay in the hospital (three days), pain scores and opioid see adductor page 28

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High Incidence of Residual Paralysis Found in Canadian Study


ore than half of patients undergoing abdominal surgery frequently have residual paralysis at extubation, despite monitoring and the use of reversal agents, Canadian researchers have found. The findings, from the RECITE

(REsidual Curarization and its Incidence at Tracheal Extubation) study, confirm preliminary results showing a surprisingly high rate of residual neuromuscular blockade (NMB) in these patients. The researchers were scheduled to present their results at the

2013 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1653570) in Calgary, Alberta, but the conference was cancelled because of flooding. Postoperative residual paralysis is associated with increased


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morbidity and critical respiratory events. RECITE enrolled 302 adults who underwent open or laparoscopic abdominal surgery at eight Canadian hospitals. The goal of the study was to investigate the incidence and severity of residual NMB immediately before extubation and on arrival in the postanesthesia care unit (PACU). Patients received at least one dose of a nondepolarizing neuromuscular blocking agent (rocuronium) for endotracheal intubation or maintenance of blockade. Acceleromyography was used to determine neuromuscular function, but the anesthesiologist was blinded to train-off four results. Neostigmine was used for NMB reversal in 74% of patients. The incidence of residual paralysis was 56% (95% confidence interval [CI], 49.7%-62.3%) at tracheal extubation and 44% (95% CI, 37.7%-50.2%) on arrival in the PACU. Among patients who received neostigmine, the incidence of residual paralysis at tracheal extubation (58.4% vs. 49.2%) and at arrival in the PACU (47.7% vs. 34.5%) was higher, although the differences were not statistically significant.



consumption were similar in the two groups. “Patients in the adductor canal group walked farther at three of the four physical therapy time points,” Dr. Workman said. Physical therapy was evaluated in the morning and afternoon on postoperative days 1 and 2. Asokumar Buvanendran, MD, director of orthopedic anesthesia and professor of anesthesiology at Rush University Medical Center, in Chicago, said the study adds to the emerging evidence demonstrating that adductor canal blocks are useful for TKA. A second study presented at the ASRA meeting (abstract 53) by researchers from Oschner Medical Center, in New Orleans, tested a single-shot adductor canal block under ultrasound guidance in TKA patients. The researchers demonstrated that this technique can provide analgesia equivalent to that from a continuous femoral nerve catheter. “We need to do prospective randomized controlled trials, but just looking at the clinical data and the anatomy and physiology, adductor canal blocks make a lot of sense,” Dr. Buvanendran said. —Kate O’Rourke

NOVEMBER 2013 I 29

CL IN ICA L A N E STH E SIOL OG Y No statistically significant difference in the incidence of residual paralysis was found between study sites. Similarly, the researchers found no difference associated with sex, age, body mass index, patient physical status, type of surgery or comorbidities. Louis-Philippe Fortier, MD, chief of staff at Maisonneuve-Rosemont Hospital in Montreal, Canada, who led the study, called the results “staggering.” “We knew from other studies that there is a high percentage of patients … who would have residual neuromuscular blockade. What is surprising about our result is that it comes from a study of different hospital settings—university hospitals and regional hospitals,” Dr. Fortier said. The Canadian group said the findings underscore the need for more effective detection and management of residual paralysis. “Since we are doing such a poor job in this particular field and there are new molecules available, the next logical step is to try to compare what’s newly available with what we’ve been doing in the last 20 years and see if it makes a difference,” Dr. Fortierr said. “We are very

concerned about the result that we got, and we’re trying to find a way to correct that. We want to find new ways to make managing neuromuscular blockade during surgery more efficient.” Sorin J. Brull, MD, professor of anesthesiology at Mayo Clinic in Jacksonville, Fla., was not surprised by the results. “We have known that postoperative residual paralysis occurs in the PACU for at least 50 years. It’s a major patient safety issue, and we have not really addressed it.” According to Dr. Brull, “Most clinicians assess subjectively the readiness for extubation. This is a major fallacy that has been perpetuated for a very long time—that they are able to detect residual block or readiness for tracheal extubation. Clearly, the results show that clinicians might as well toss a coin when making the decision when to extubate because they can’t tell subjectively. Clinicians should use objective means of evaluation.” The study was funded by Merck, maker of sugammadex, a reversal agent available in Europe and Asia but not yet available in the United States. —Mandy Armitage, MD

Opioid Prodrugs Aim To Reduce Likelihood of Abuse esearchers at the pharmaceutical company Signature Therapeutics have developed opioid prodrugs that may decrease the potential for abuse. Prodrugs of hydrocodone, oxycodone and hydromorphone released their parent opioids when given orally but were inactive following IV administration in rats. “This represents a molecular approach” to abuse-deterrent opioids, said Steven Shafer, MD, professor in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University Medical Center, in Stanford, Calif., and a founder of Signature Therapeutics. Existing approaches to abuse deterrence rely on the drug formulation, which Dr. Shafer said is “fairly easy to defeat” through chemical extraction. To ensure activity only during oral administration, researchers created extended-release and immediate-release prodrugs that require molecular cleavage by trypsin in the digestive system. In rats, IV prodrugs had less than 2% of the penetration across the blood–brain barrier than did the parent opioids, suggesting they would be less than 0.1% as potent. A randomized, blinded study of healthy volunteers compared the bioavailability of


extended-release hydromorphone with that of the hydromorphone prodrug. Participants received hydromorphone (n=12, 0.5-24 mg) or the hydromorphone prodrug (n=39, 1-48 mg) orally. Both groups showed linear increases of plasma hydromorphone levels, with a peak at one hour for hydromorphone and between three and four hours for the prodrug. The researchers also subjected the oxycodone and hydromorphone prodrugs to a battery of “kitchen chemistry” tests, which included boiling with olive oil, vinegar, 190-proof Everclear, baking soda, Coca-Cola and water. None of these conditions released oxycodone, and hydromorphone was released only when boiled for one hour in baking soda or Coca-Cola, extracting less than 2% of the drug. Dr. Shafer is in talks with potential partners in the pharmaceutical industry, and he expects the prodrugs will move to Phase III trials within three years once a partnership is established. He presented this work at the 2013 PAINWeek Conference in Las Vegas (abstracts 144, 145, 146 and 147). —Ben Guarino

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Waleed Riad Soliman, MD, PhD, a perioperative fellow in the Department of Anesthesia at Toronto Western Hospital in Ontario, Canada, said his clinical experience suggested this approach was inadequate. “I observed that patients were not adequately anesthetized and developed tachycardia and hypertension in response to intubation,” Dr. Soliman said. Dr. Soliman and several colleagues randomized 60 patients undergoing bariatric surgery with a body mass index of at least 40 kg/m2 to receive propofol induction based on their LBW or to be directed according to BIS values. All participants received fentanyl dosed at 3 mcg/kg of LBW and propofol at an infusion rate of 100 mg/kg per hour. In the LBW group, patients received a precalculated

propofol dose of 2.6 mg/kg LBW, an approach Dr. Soliman borrowed from a recommendation published in 2011 (Best Pract Res Clin Anaesthesiol 2011;25:27-39). In the BIS-monitored group, propofol infusion was stopped once BIS dropped to 50. In both groups, anesthesiologists rated the patients’ level of consciousness using the Observer’s Assessment Alertness/Sedation Scale (OAA/S). The study was not blinded. According to Dr. Soliman, the mean LBWW basedd precalculated propofol dose was 163.5 mg compared with a mean 225.4 mg propofol required for deep sedation in the BIS group (P<0.05). The mean OAA/S score achieved in those patients with a full propofol dose calculated using LBW was 1 (range 0-3), indicating inadequate sedation. In the BIS group, mean OAA/S scores were 0 (P<0.05 for LBW vs. BIS).

Dr. Soliman said 60% of patients (18 of 30) in the LBW group required additional propofol for induction to achieve deep sedation compared with 3.3% (one of 30) of the BIS patients who required more propofol beyond the dose administered at a BIS value of 50 (P<0.05). Total induction doses administered in the two groups did not differ significantly; the researchers found a mean 204 mg in the LBW group and 228 mg in the BIS group. There also were no differences in heart rate between the two groups during intubation. However, mean arterial pressure was significantly higher in the LBW group following intubation and through to five minutes after intubation. Daniel I. Sessler, MD, Michael Cudahy Professor and chair of the Department of Outcomes Research at the Cleveland Clinic, in Ohio, said

using total body weight rather than LBW to calculate propofol induction dosing is probably a better strategy in obese patients. Dr. Sessler, who was not involved in the study, pointed to a 1993 publication that supported this view ((Anesthesiology 1993;78:657-665). “The pharmacokinetics of propofol in the obese from those results were clear,” Dr. Sessler said. “Volume of distribution and clearance both increased linearly with body weight, and there was thus no accumulation of the drug. The authors therefore concluded that ‘dosing schemes expressed in mg/kg are the same as those in normal patients.’” Dr. Soliman’s findings were to be presented at the Canadian Anesthesiologists’ Society’s 2013 annual meeting (abstract 1625814) in Calgary, Alberta. The meeting was canceled because of flooding. —David Wild

Commentary by Jerry Ingrande, MD, MS


Weight, kg

have read with great interest the study by Soli200 TWB man et al, exploring titration of propofol to loss Servin of consciousness (LOC) using the bispectral index LBW (BIS, Covidien) versus lean body weight (LBW) in morbidly obese patients. However, I find their 150 conclusion—titration to BIS being superior to LBW—questionable. There is significant hysteresis between processed electroencephalogram (EEG) and drug 100 effect. The lag time between LOC and BIS values will result in administration of excess propofol. Unless the authors analyzed the raw EEG output, the occurrence of this hysteresis can50 not be avoided, resulting in a drug overdose. The 20 30 40 50 60 decreased incidence of hypertension and administration of rescue propofol in the BIS group likely BMI is secondary to drug overdose resulting from the A schematic of body mass index to total body weight (TBW), hysteresis between BIS values and LOC. Servin et al’s corrected weight (Servin), and lean body weight The authors state that dosing to LBW provides (LBW), as calculated by Janmahasatian’s equation,5 for a an inadequate amount of propofol. This simply is standardized height. not true. A recent study examining dosing scalars for the induction dose of propofol in obese maintenance dosing) were similar in both obese and individuals found that LBW was the most approprinon-obese participants.2 They concluded that proate weight-based scalar.1 The study used an infupofol can be administered to the obese on a mg/kg sion of 100 mg/kg per hour, but allowed the infusion scale similar to normal-weight individuals. However, to continue until the LOC end point was reached.1 during induction of anesthesia, doses are determined Mean dose requirement for propofol was 2.76 mg/kg by a drug’s front-end kinetics. The front-end kinetof LBW. In the study by Soliman et al, the induction ics describe the early distribution of drug after it is dose for the LBW group was predetermined (2.5 mg/ administered.3 Early distribution kinetics are governed kg). The authors did not try other doses, nor did they by cardiac output. administer the drug until a conclusive marker of LOC Servin et al’s findings show that although clearance was reached. A more appropriate conclusion, then, and volume of distribution at steady state increase would be that titration to BIS may be superior to a with weight, initial volume of distribution was not fixed d dose of 2.5 mg/kg LBW. different compared with normal-weight individuals. In one of the first studies examining propofol pharPhysiologically and pharmacologically, there is no reamacokinetics in the obese, Servin et al demonstrated son to account for the increased fat mass found in that clearance and volume of distribution at steady obese individuals when administering a loading dose. state (factors important to back-end kinetics and It is interesting to note that in Servin et al’s study,

a modified weightbased dosing scalar that closely approximates LBW was used for propofol administration (Figure). Because the frontend kinetics govern induction dose, cardiac output should Jerry Ingrande, MD, MS be taken into account before administering an induction dose. Cardiac output has been shown to strongly correlate with LBW.4 Propofol induction doses in morbidly obese individuals correlate with both cardiac output and LBW.1 The use of LBW as a dosing scalar for propofol in the obese population is based on the physiologic changes occurring in these patients, and thus is a rational method for determining induction dose. Dr. Ingrande is instructor and head of Bariatric Anesthesia in the Department of Anesthesia at Stanford University School of Medicine in Stanford, Calif.

References 1. Ingrande J, Brodsky JB, Lemmens HJ. Lean body weight scalar for the anesthetic induction dose of propofol in morbidly obese subjects. Anesth Analgg 2011;113:57-62. 2. Servin F, Farinotti R, Haberer JP, et al. Propofol infusion for maintenance of anesthesia in morbidly obese patients receiving nitrous oxide. A clinical and pharmacokinetic study. Anesthesiology 1993;78:657-665. 3. Krejcie TC, Avram MJ. What determines anesthetic induction dose? It’s the front-end kinetics, doctor! Anesth Analgg 1999;89:541-544. 4. Collis T, Devereux RB, Roman MJ, et al. Relations of stroke volume and cardiac output to body composition: the strong heart study. Circulationn 2001;103:820-825. 5. Janmahasatian S, Duffull SB, Ash S, et al. Quantification of lean bodyweight. Clin Pharmacokinett 2005;44:1051-1065.

THE ULTIMATE ANESTHESIA INFORMATION MANAGEMENT SYSTEM Discover the Power of Anesthesia TouchTM Plexus Information Systems, Inc. (Plexus IS), a subsidiary of Plexus Management Group, Inc., presents Anesthesia Touch™, a functionally rich AIMS that offers the most adaptability and scalability in the industry. Anesthesia Touch is the only AIMS solution to offer direct integration with all EMRs in the U.S.A. Anesthesia Touch gives anesthesia providers the power to manage information electronically from single providers to the largest IDNs on one simple interface from multiple platforms and locations.

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REPORT Infiltration of the Transversus Abdominis Plane With EXPAREL for Postsurgical Pain Management Postsurgical Pain Continues To Impact Patients and Hospitals Alike Despite new technologies and surgical techniques, postsurgical pain remains a common phenomenon and can have a significant effect on patient recovery. It is increasingly important due to the rising numbers of both inpatient and outpatient surgeries. The latest Centers for Disease Control and Prevention estimates show that 51.4 million inpatient procedures are performed each year,1 in addition to 53.3 million ambulatory surgeries.2 As these figures increase, there is a growing need to adequately manage postsurgical pain. Unfortunately, research has found that postsurgical pain remains undermanaged in the majority of patients.

In 2003, Apfelbaum and colleagues conducted a survey of 250 surgical patients, which found that 82% experienced some pain for up to 2 weeks following surgery and 76% of all surgical patients required analgesic medication after discharge.3 Of the patients experiencing pain, 86% reported moderate, severe, or extreme pain.3 It should be noted that 23% of patients who were prescribed pain medications experienced adverse events (AEs).3 In order to determine if there were any changes since Apfelbaumâ&#x20AC;&#x2122;s study, in 2012 Gan and colleagues assessed postsurgical pain and subsequent pain medication prescriptions in a cohort of 300 patients.4 Unfortunately, there was no apparent change, as more than 86% of patients reported experiencing pain after surgery with

Faculty Sabry Ayad, MD

Jeffrey J. Gonzales, MD

Raghavender Thunga, MD

Chairman, Department of Anesthesiology and Pain Management Fairview Hospital, Cleveland Clinic Cleveland, Ohio

Assistant Professor Director of Clinical Spine Services Division of Orthopedic and Plastic Surgery Department of Anesthesiology Duke University Medical Center Durham, North Carolina

Chief Medical Officer, LIG Global Foundation President, Lake County Anesthesiologists Ltd Division of Midwest Anesthesia Partners Ltd. Libertyville, Illinois

Supported by


45 40%

Patients Reporting Moderate to Severe Pain, %

40 35 30 24%

25 20


15 10 5 0 POD 1



Figure 1. Time course of moderate to severe pain after ambulatory surgery in a cohort of 89 patients. Data taken from Beauregard, et al. 1998. POD, postoperative day

more than 75% of these patients reporting moderate, severe, or extreme pain.4 Analgesic medications were prescribed to 88% of patients, with the majority of prescriptions being for opioids.4 Of the patients receiving analgesics, 80% reported AEs with most of the described AEs attributable to opioids.4 One reason for the undermanagement of postsurgical pain may be related to its protracted time course. Beauregard and colleagues assessed pain levels after ambulatory surgery and reported that 40% of patients had moderate to severe pain during the first 24 hours after discharge.5 Although this pain decreased with time, patients continued to report pain up to postoperative day (POD) 7 (Figure 1), at which time 44% of patients reported that their pain was still severe enough to interfere with daily activities.5 Similarly, Lynch and colleagues assessed pain after elective noncardiac surgery and reported that pain levels had decreased only slightly by POD 3.6 Inadequately controlled postsurgical pain can result in a variety of adverse outcomes for the patient.7 In addition to needless suffering, the undertreatment of postsurgical pain may


result in an extended surgical recovery time that may include unanticipated hospital readmission and a stay in the intensive care unit.7 Furthermore, patients with extended periods of postsurgical pain may develop chronic pain and impaired quality of life during their recovery.7 Undermanaged postsurgical pain not only affects the patient, it also impacts overall health care costs by increasing the rate of readmission and requiring extended hospital lengths of stay (LOS). In a retrospective study involving more than 20,000 patients who underwent outpatient surgery, Coley and colleagues identified all nonelective return hospital visits within 30 days of surgery and categorized the reasons for returns.8 Investigators found that 5.7% of patients had an unplanned admission either directly after surgery or within the first 30 days; 38% of these patients cited pain as the reason for their admission.8 Of the patients readmitted for pain, 68% were admitted within the first 7 days,8 a time course that coincides with the highest incidence of pain. 5 The average LOS for patients with pain was 2 days, which incurred an average charge of $1,869 per patient.8


In addition to increasing overall health care costs, undermanaged postsurgical pain directly correlates with patient satisfaction. In turn, patient satisfaction has recently been tied to hospital reimbursements provided by the Centers for Medicare & Medicaid Services (CMS).9 A post-hospitalization survey conducted by the hospitals on behalf of CMS assesses overall patient satisfaction with their hospital care and includes several questions about pain management.10 The results of this survey are used to calculate up to 30% of the reimbursement offered by the CMS for services rendered by the hospital to the patient.9 Therefore, pain management is becoming an increasingly crucial factor for overall health care costs. Despite the growing awareness of the value of multimodal pain management plans, opioid monotherapy remains the gold standard to treat postsurgical pain. As described in this monograph, an alternative to opioid monotherapy that includes new agents and techniques such as EXPAREL® (bupivacaine liposome injectable suspension) and transversus abdominis plane (TAP) infiltrations should be incorporated into multimodal pain management plans in order to reduce reliance on opioids.

Postsurgical Pain Management With Opioid Monotherapy Has Limited Benefits Opioids remain widely used for postsurgical analgesia because they are highly effective and available in a wide variety of formulations. However, opioids exhibit various dose-limiting side effects that can vary from patient to patient and range from bothersome to life-threatening including, but not limited to nausea, vomiting, constipation, oversedation, somnolence, and respiratory depression.11-13 In fact, according to a Sentinel Event Alert issued by the Joint Commission, opioids rank among the drugs most frequently associated with AEs, particularly in patients ranging from the elderly and sleep apneic to the obese and smokers—all of whom are at an increased risk for developing severe AEs such as oversedation and respiratory depression.13 A recent study by Oderda and colleagues used a large, national hospital database to assess the effects of opioid-related AEs (ORAEs) in 319,898 surgical patients.14 These researchers found that approximately 12% of patients experienced an ORAE and that the occurrence of ORAEs coincided with a 3.3-day increase in LOS and a $4,707 increase in hospitalization costs.14 The patients experiencing ORAEs also were more likely to be readmitted to the hospital within 30 days of their surgeries (15.8% vs 9.4%).14 Kessler and colleagues performed a similar analysis of more than 37,000 surgical patient records among 26 hospitals in the Southeast.15 In this study, the authors reported that 13.6% of patients receiving opioids experienced an ORAE that resulted in hospital LOS being lengthened by an average of 3.4 days or 55%.15 In addition, patients experiencing ORAEs

had 36% higher hospital readmission rates at 30 days.15 These more frequent and longer hospitalizations translated into higher health care costs; the cost per patient increased by $6,721 when they experienced an ORAE.15 Finally, ORAEs were associated with a 3.4-fold increased risk for inpatient mortality.15 The limitations of opioid therapy combined with the evidence of undertreatment of postsurgical pain have led several medical organizations to issue guidelines urging clinicians to take a multimodal approach to manage postsurgical pain. The American Society of Anesthesiologists (ASA)7 and Veterans Health Administration that is part of the US Department of Defense (VHA/DoD)16 both stress the need to design an individualized multimodal pain management plan in order to reduce the reliance on opioids and to minimize the incidence of ORAEs.

The Multimodal Approach to Postsurgical Pain Management The ASA defines the multimodal approach to pain management as the “administration of two or more drugs that act by different mechanism for providing analgesia.”7 Among the recommendations from the ASA and others is the inclusion of an around-the-clock regimen of acetaminophen, cyclooxygenase2-selective nonsteroidal anti-inflammatory drugs (NSAIDs), or nonselective NSAIDs as well as regional blocks with local anesthetics,7,16 which impede the transmission of nociceptive signal by blocking sodium channels in neurons and are associated with a low incidence of AEs.17,18 Studies also have found that the use of local anesthetics decreases the need for opioids and thereby decreases the incidence of ORAEs while simultaneously increasing patient satisfaction and decreasing hospital LOS.18,19 Despite their efficacy, the main concern regarding the use of local anesthetics is the short duration of analgesia since they typically last no longer than 6 to 8 hours.19 One method to extend analgesia is to implant a catheter attached to an elastomeric pump that continuously infuses the surgical site with local analgesics.17,20 However, both the FDA 21 and the Institute for Safe Medication Practices (ISMP) 22 have raised concerns about the safety of elastomeric pumps. These concerns led the ISMP to issue a warning that the devices are filled outside of the pharmacy, typically in the operating room, which may compromise accurate filling, labeling, and documentation of the administered medication.22 Another concern raised by the ISMP is the variability in infusion rates; elastomeric pumps typically operate within 15% of the set flow rate, and it is important to avoid overfilling or underfilling of the reservoirs.22 An alternative to continuous infusion of local anesthetics is to perform a single-dose infiltration to the site as a field block before incision, during surgery, during the final stages of the surgical procedure, or sometimes in the postanesthesia care unit (PACU).17,23 One such approach that can be used during abdominal/pelvic surgeries is to infiltrate the transversus abdominis



External oblique Internal oblique Transversus abdominis

Figure 2. Needle and probe placement to perform infiltrations of the TAP under ultrasound guidance. Inset image courtesy of Dr. Ayad. TAP, transversus abdominis plane

plane (TAP), which contains a substantial number of nerves.24 Despite the fact that single-dose infiltration of the surgical site eliminates the risk for known catheter-related AEs20 and complications,17 the length of analgesic efficacy is largely dependent on the duration of the local anesthetic used.23 Therefore, the following article shows how the analgesic efficacy of TAP infiltrations can be extended through the use of innovative local anesthetic formulations such as EXPAREL that slowly releases bupivacaine into the surgical site over time.25

Transversus Abdominis Plane Infiltration As a Component of Multimodal Analgesia In Surgical Patients First described by Rafi in 2001 as an anatomic landmarkguided field block for abdominal surgeries, TAP infiltrations with


local anesthetics provide analgesic coverage to the intercostal nerves T7 to T11, the T12 subcostal nerve, and the ilioinguinal nerve and iliohypogastric nerve (L1-L2).24 TAP infiltration delivers a local anesthetic to the space between the internal oblique and transversus abdominis muscles before the surgical incision or just before wound closure (Figure 2).24 More recently, TAP infiltration is performed under ultrasound guidance, thereby allowing the anesthesiologist to reliably and accurately place the tip of the needle into the TAP space under direct, real-time visualization. Due to the ease of administration and efficacy, TAP infiltration also has been successfully used in the immediate postsurgical period—for example, in the PACU—as “rescue” analgesic to replace the use of additional opioids. 26,27 To date, there have been 2 reported significant postoperative complications, in particular liver trauma, with the ultrasound-guided TAP


infiltration; these cases involved excessive needle penetration resulting from either poor ultrasound visualization28 or a lack of liver palpation.29 It should be noted that the ASA recommendations for a multimodal approach to pain management cites regional blockades with local anesthetics, an approach that encompasses TAP infiltration.7 The TAP infiltration approach to analgesia in surgical patients is an increasingly popular option, with numerous training programs and congresses focusing on expanding its use. Despite the fact that this procedure was developed only a little over a decade ago, there is a large and growing body of evidence to support its use. Indeed, as can be seen in the studies described here, TAP infiltration has been successfully performed in a variety of settings that involve the lower abdominal wall. As such, TAP infiltration can be clinically useful in bowel surgery, appendectomy, hernia repair, umbilical surgery, and gynecological surgery.30 A substantial quantity of safety and efficacy data has allowed comprehensive meta-analyses of this approach. For example, Champaneria and colleagues performed a meta-analysis of randomized controlled trials (RCTs) of TAP infiltration on 255 patients undergoing gynecological surgery whose results were published in 5 studies.31 When compared with placebo, TAP infiltration was associated with significantly less postsurgical pain both during movement and at rest during the first 2 hours postsurgery.31 However, any difference in pain levels between the treatment groups disappeared by 24 hours postsurgery.31 During the first 24 hours after surgery, the patients who received TAP infiltration also required a decreased amount of morphine compared with the placebo group, but, once again, this effect was ameliorated within 48 hours postsurgery.31 In a similar meta-analysis of RCTs (4 studies with 174 participants), Siddiqui and colleagues found that TAP infiltration reduced the need for opioids and subsequent ORAEs, while also observing an increased time to the first request for additional analgesia.32 A meta-analysis of RCTs (9 studies with 413 participants) performed by Johns and colleagues found that morphine consumption was decreased by more than 20 mg in the first 24 hours, which contributed to a decrease in the cumulative morphine consumption over 48 hours postoperatively.33 This was also the first analysis to find an association between TAP infiltration and reduced postoperative nausea and vomiting (PONV). 33 Finally, a comprehensive Cochrane analysis of 8 RCTs with 358 participants found that for the first 24 hours after abdominal surgery, TAP infiltration resulted in both reduced opioid consumption and reduced pain scores.34 The use of TAP infiltration in the ambulatory surgery setting also has been examined. For example, De Oliveira and colleagues performed a prospective, randomized, double-blind study to survey 70 patients undergoing outpatient laparoscopy who received either a TAP infiltration with ropivacaine or a placebo.35 TAP infiltration resulted in patients being

discharged 30 minutes earlier with reduced pain scores and reduced opioid usage for 24 hours after surgery.35 Patients receiving a TAP infiltration also reported an improved quality of recovery compared with those patients who received a saline injection.35

EXPAREL: An Innovative, Long-Acting Formulation of Bupivacaine Local anesthetics with a longer duration of action are preferred to maximize the duration of analgesia in postsurgical patients. In that regard, bupivacaine hydrochloride (HCl) is particularly effective in reducing postsurgical pain because it is known to have a rapid onset of analgesia with a significantly longer, analgesic durationâ&#x20AC;&#x201D;up to approximately 8 hoursâ&#x20AC;&#x201D; as compared with other commonly used local anesthetics.36 When compared with ropivacaine, bupivacaine provides analgesia that is extended by an average of 4 hours.37 However, even the extended analgesia provided by bupivacaine remains insufficient to match the duration of postsurgical pain.5,6 EXPAREL was approved by the FDA in 2011 as a novel liposomal formulation of bupivacaine that provides up to 72 hours of postsurgical analgesia with reduced opioid requirements indicated for single-dose administration into the surgical site. 25 EXPAREL is supplied in ready-to-use 20 mL vials with a bupivacaine concentration of 13.3 mg/mL (total dose, 266 mg). 25 The bupivacaine in EXPAREL is encapsulated within multivesicular liposomes (DepoFoamÂŽ) that slowly break down and release the anesthetic over time (Figure 3).25,38,39 The lipid membranes of the multivesicular liposomes are composed of naturally occurring or close analogues of endogenous lipids that are well tolerated and cleared through normal metabolic pathways.38 Furthermore, the liposomes are suspended in an aqueous solution composed of normal saline and therefore can be further expanded to a total volume of 300 mL with preservative-free normal saline, as necessary, to accommodate administration into a larger surgical site without affecting analgesic efficacy.25 In addition to the encapsulated bupivacaine, EXPAREL also contains a small amount of free bupivacaine that can be immediately absorbed, thereby creating an early analgesic effect.38,39 Systemic plasma levels of bupivacaine have been detected as soon as 15 minutes after injection.38,39 The bupivacaine contained within the liposomes is then slowly released to provide therapeutic levels of analgesia for up to 72 hours, which more closely matches the time course of the most intense postsurgical pain.38 The safety and efficacy of EXPAREL in wound infiltration was demonstrated in 2 pivotal, randomized, double-blind, placebo-controlled, parallel-group Phase III trials involving soft tissue and orthopedic surgical models; these trials served as the basis of the FDA approval. Golf and colleagues performed a Phase III trial with patients undergoing bunionectomy who received placebo or 106 mg of EXPAREL.40 EXPAREL


Plasma Bupivacaine Concentration, ng/mL


Inguinal hernia – 266 mg Hemorrhoidectomy – 266 mg Bunionectomy – 106 mg

900 800 700 600 500 400 300 200 100 0 0













Time, h Figure 3. Absorption profile of EXPAREL following local infiltration during soft tissue and orthopedic surgeries. Based on reference 38. (Inguinal hernia repair, n=12; hemorrhoidectomy, n=25; bunionectomy, n=26)

decreased pain scores and the need for rescue medication, as well as significantly reducing the time to first opioid use and total amount of opioids used.40 The authors further found that the use of EXPAREL did not affect wound healing and that the majority of reported AEs were mild to moderate; the most commonly reported AEs were nausea, vomiting, dizziness, headache, and general pruritus.40 The second pivotal, randomized, double-blind, placebocontrolled, parallel-group Phase III trial was conducted by Gorfine and colleagues, who randomized 189 patients undergoing 2- to 3-column excisional Milligan-Morgan hemorrhoidectomy to receive either a single dose (266 mg) of EXPAREL (n=95) or saline placebo (n=94), administered intraoperatively via wound infiltration.41 Patients in the EXPAREL group reported a statistically significant 30% reduction in cumulative pain scores and a 45% reduction in opioid consumption through


72 hours following surgery.41 Furthermore, more patients in the EXPAREL group remained opioid-free from 12 hours (59% vs 14%) to 72 hours (28% vs 10%) after surgery compared with patients who received placebo.41 The median time to first opioid use was 14.3 hours in the EXPAREL group versus 1.2 hours in the placebo group.41 The authors also found that EXPAREL did not affect wound healing and that the reported AEs were mild, with the most frequently reported being anal hemorrhage and painful defecation.41 The safety of EXPAREL has been evaluated in multiple studies throughout the clinical development program. Viscusi and colleagues pooled safety data from 10 double-blind RCTs that included more than 800 patients who received EXPAREL administered via infiltration into the surgical site.42 More than 90% of the AEs were classified as mild or moderate and the most common AEs in the EXPAREL arms were nausea (3.3%), constipation



Mean (SD) NRS Score





0 0










Hours After Surgery

Figure 4. Pain intensity scores over 5 days following TAP infiltration using EXPAREL in 13 patients undergoing open abdominal hernia repairs. Based on reference 43. NRS, numeric rating scale; SD, standard deviation; TAP, transversus abdominis plane

(2.0%), and vomiting (1.3%).42 Serious AEs were reported in 2.7% of patients receiving EXPAREL versus 5.4% and 1.1% of those receiving bupivacaine HCl and placebo, respectively. There was one reported death that was deemed to be unrelated to the drug.42 The authors reported that some AEs involved the cardiac (6.4%) and nervous (14.5%) systems, but all were classified as mild to moderate with a rate of occurrence similar to that seen in patients treated with bupivacaine HCl (5.8% and 14.6%, respectively).42

EXPAREL Is Gaining Usage in TAP Infiltration Early results from single-center open-label, historically controlled clinical studies 43,44 using EXPAREL in TAP infiltration have found that its unique formulation safely extends

postsurgical pain management up to 72 hours; in comparison, when other local anesthetics are used in TAP infiltration, analgesia typically only lasts for up to 24 hours.34 At the 2013 Annual Meeting of the International Anesthesia Research Society, Feierman and colleagues presented their experience with EXPAREL for TAP infiltration in 13 patients undergoing open abdominal hernia repair under general anesthesia.43 The authors reported that the average patient-reported pain score (based on an 11-point numeric rating scale [NRS], with 0 being no pain and 10 being worst possible pain) was 0.6 before the surgery was performed and after surgery, patient pain scores remained below 3 through POD 5 (Figure 4).43 Average pain scores were 0.9 by POD 5 and decreased to 0.4 by POD 10.43 The median time to first use of supplemental analgesia postoperatively was 11 hours (range <1 to 71 hours).43 Furthermore, there were no AEs, with most patients



reporting that they were either satisfied or extremely satisfied with postsurgical pain control at discharge and POD 10.43 Sternlicht and colleagues presented similar results regarding their experience with EXPAREL in TAP infiltration during robotic prostatectomy surgeries at the American Society of Regional Anesthesia and Pain Medicineâ&#x20AC;&#x2122;s Annual Fall Pain Meeting in 2012.44 These investigators found that patients (N =24) receiving TAP infiltration required an average of 0.7 oxycodone/acetaminophen (APAP) tablets per day from discharge until POD 10.44 This resulted in a cumulative average oxycodone/APAP (5/325 mg) dose of approximately 6 pills.44 Furthermore, there were no patientreported pain scores (based on an 11-point NRS, with 0 being no pain and 10 being worst possible pain) higher than 3 at any time after 2 hours postsurgery.44 This likely translated into the high rates of patient satisfaction with postsurgical pain control at all time points assessed; 100% of patients reported being either satisfied or extremely satisfied at 72 hours and POD 10.44 No treatment-related AEs occurred in any of the patients.44

Conclusion Postsurgical pain is a common phenomenon that contributes to worse patient outcomes and higher health care costs. Additionally, most postsurgical pain is managed through the use of opioids, despite their increased risk for potential AEs. Therefore, there is increasing awareness


that multimodal pain management regimens are effective in adequately managing postsurgical pain and reducing the reliance on opioids. Current ASA guidelines recommend that multimodal analgesia should incorporate a combination of analgesics that act through a variety of mechanisms, including regional blockade with local anesthetics. One such regional blockade technique that is increasingly popular is the ultrasound-guided infiltration of local anesthetics within the TAP. However, the pharmacokinetics of most local anesthetics does not match the time course of intense postsurgical pain. A pivotal, randomized, double-blind, placebo-controlled, parallel-group Phase III trial conducted in a soft tissue surgical model has demonstrated that wound infiltration with EXPAREL is effective at reducing postsurgical pain and opioid requirements through 72 hours, while 2 small, openlabel, historically controlled single-center studies recently presented at national anesthesia meetings have also shown that EXPAREL can be used for TAP infiltration. This treatment combination should be considered by surgeons and anesthesiologists as part of multimodal pain management plans with the goal of extending postsurgical pain management and reducing the need for opioids. As can be seen in the accompanying case studies and anecdotal report, because of the many benefits of using EXPAREL in TAP infiltrations, anesthesiologists are rapidly adopting this enhanced pain management strategy.


Case Study 1 61-year-old man undergoing radical robotic retropubic prostatectomy, lysis of adhesions, and bilateral pelvic lymph node dissection Sabry Ayad, MD


he patientâ&#x20AC;&#x2122;s medical history included a 4.3-cm ascending thoracic aortic aneurysm, aortic valve regurgitation, hiatal hernia, gastroesophageal reflux disease, chronic obstructive pulmonary disease, anemia, and prostate cancer. He was taking cyclobenzaprine 10 mg, tadalafil 5 mg, alprostadil 20 mcg injection, albuterol sulfate, omeprazole 20 mg, ferrous sulfate 325 mg, and a multivitamin. His preoperative vital signs and physical examination were within normal limits, and laboratory investigations found no abnormalities. Following the standard basic anesthesia monitoring protocols as recommended by the ASA, general anesthesia with endotracheal intubation was performed using sevoflurane as the inhalational agent. The patient also was given IV 2 mg midazolam, 20 mg etomidate, 100 mcg fentanyl, 8 mg of morphine sulfate, 8 mg of dexamethasone, 1 g APAP, 4 mg ondansetron, and 30 mg ketorolac. Invasive lines were a left radial arterial line and a right internal jugular triple-lumen central venous catheter. During the procedure, the patient was placed in the lithotomy position. The overall length of the procedure was 6 hours and 33 minutes, during which time the patient received 2 L of 0.9% normal saline. His urine output was 350 mL and his estimated blood loss was 350 mL. Both procedure and anesthesia management were uneventful.


Immediately before extubating the patient, ultrasoundguided bilateral TAP infiltrations were successfully performed using a 22-gauge Tuohy needle (Figure 5). One 20 mL vial of EXPAREL (266 mg) was diluted in 20 mL of preservative-free sterile normal saline and divided into equal volumes (20 mL) in order to perform TAP infiltration on each side. The patient emerged uneventfully from anesthesia and at emergence reported a pain score of 1 out of 10 on the numeric rating (NRS) with 0 being no pain and 10 being worst possible pain. After emergence, the patient was placed on an analgesia regimen of patient-controlled, on-demand only IV morphine sulfate and 1 g of APAP every 6 hours. The patient first requested pain medication 13 hours postoperatively. On POD 1, he used 10 mg of morphine sulfate. That usage declined to 7 mg on POD 2. The patient was discharged home on POD 3. Adjuvant analgesia provided in-hospital consisted of 3 doses of IV APAP and 2 doses of 30 mg IV ketorolac. On POD 1, the patient reported his pain as 1 on the pain scale, and by POD 2, his pain was between 2 and 3 on the pain scale. By discharge, the patientâ&#x20AC;&#x2122;s pain was reduced to a pain score of 1 at rest and 3 during movement. The patient reported no AEs such as nausea or vomiting and was extremely satisfied with his pain management.


Figure 5. TAP infiltration being performed under ultrasound guidance. (A) Negative aspiration and distention of fascial plane. (B) Post injection of EXPAREL. Images courtesy of Dr. Ayad. TAP, transversus abdominis plane



Case Study 2 37-year-old woman scheduled for supraumbilical ventral hernia repair Jeffrey J. Gonzales, MD


he patient presented with ulcerative colitis and suffers from chronic abdominal pain that is managed with opioids; she currently takes 7.5 mg methadone and 50 mg pregabalin every 8 hours. She normally functions at between 4 to 6 out of 10 on the pain scale. The initial anesthesia plan called for general anesthesia and an epidural for postoperative pain management. Her operation was scheduled as the first case of the day, so she was instructed to take her usual methadone and pregabalin doses the morning of the surgery. The plan was to discharge the patient on POD 2. During preoperative discussions, the patient declined the epidural due to failures during previous surgeries. At that point, the anesthesia plan was modified with the patientâ&#x20AC;&#x2122;s approval to include bilateral TAP infiltrations for postoperative pain management. The patient was induced with propofol, fentanyl, lidocaine, and succinylcholine. Before the operation began, bilateral ultrasound-guided TAP infiltrations were initiated with 10 mL of 0.25% bupivacaine HCl to determine the correct location for TAP infiltration. One 20 mL vial of EXPAREL (266 mg) was diluted with 30 mL of preservative-free normal (0.9%) sterile saline for a total volume of 50 mL, which was split into two 25 mL aliquots and administered bilaterally into the TAP space. Intraoperatively, the patient received a bolus of 0.5 mg/kg of IV ketamine and 1 mg of IV hydromorphone. Her hemodynamics were stable throughout the procedure. Of note, 2 mg of vecuronium was used after the initial succinylcholine dose wore off; the surgeon did not request another dose of vecuronium, thereby suggesting that her abdominal wall was sufficiently relaxed from the initial dose. After the surgical procedure and extubation, which were both uneventful, the patient recovered in the PACU for 50 minutes. Her initial pain score was 4 out of 10 on the pain scale. In


the PACU, she received a total dose of 1.0 mg of IV hydromorphone, 15 mg IV ketorolac and 1,000 g of IV acetaminophen for postoperative pain management. She was discharged to the floor, as her pain score remained at 4 out of 10 and she was able to rest comfortably. On the surgical ward, the patient was given 7.5 mg methadone every 8 hours, 50 mg pregabalin every 8 hours, and 15 mg IV ketorolac every 6 hours for 24 hours. She also was prescribed 5- to 15-mg oxycodone to take depending on her reported pain score and resulted in her receiving 3 doses totaling 20 mg. She received 10 mg of oxycodone 6 hours after her procedure when she reported her pain to be 6 out of 10 on the pain scale. The next morning, she was given another 5 mg of oxycodone when her pain score was 4 out of 10. In the evening of POD 1, she was given another 5 mg of oxycodone when her pain score was 3 out of 10. During POD 1, she reported her highest pain score as 6 out of 10, which was within her normal daily pain threshold. Continuing to follow the preoperative plan, she was discharged the afternoon of POD 2 when she reported a pain score of 3. Her IV ketorolac was changed to a standing order for ibuprofen to be used concomitantly with her existing prescriptions for methadone and pregabalin. The patient was also given 18 oxycodone pills to take every 4 hours (5-10 mg) to manage any acute pain. After 3 days she followed up with her general surgeon and reported that she had taken only 3 pills for a total dose of 15 mg. During this time, she continued her methadone and pregabalin doses. Overall, the patient reported being very satisfied with the multimodal pain management employed during her operation and denied any PONV. This case report demonstrates the potential of using long-acting local anesthetics such as EXPAREL in TAP infiltration in a patient requiring chronic narcotics for long-standing pain management.


An Anesthesiologist’s Experience of Using EXPAREL in TAP Infiltration Across Several General Surgical and Gynecological Procedures Raghavender Thunga, MD


revious experience with TAP infiltrations performed with bupivacaine HCl had shown that analgesia was short-lived. However, the innovative formulation of EXPAREL was known to extend analgesia beyond that of bupivacaine HCl. Therefore, a pain management plan was designed that included the use of EXPAREL in TAP infiltration in order to reduce the need for opioids. All of the patients were prescreened, with the majority of them being relatively healthy and falling into ASA categories 1 or 2. Some patients had undiagnosed hypertension and mild obesity, which were not significant enough to postpone the required procedures. In total, EXPAREL was given as infiltration into the TAP under ultrasound guidance in 13 surgical procedures: 5 umbilical/ventral hernia repairs, 5 total abdominal hysterectomies, and 3 oophorectomies. Perioperatively, either spinal or combined spinal/epidural anesthesia was used. To manage postsurgical pain, all of the patients underwent ultrasound-guided TAP infiltrations while in the recovery room when the spinal anesthesia was still in effect. Depending on the surgical procedure, a 20 mL vial of 1.3% EXPAREL was

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL.

diluted in 0.9% preservative-free sterile normal saline up to a maximum volume of 60 mL, and up to 30 mL of the diluted EXPAREL was infiltrated on each side. The hysterectomy patients reported some breakthrough pain (BTP) that was described as a vague cramping pain; rescue medication was provided to them through the epidural with intermittent doses of a local anesthetic. Two of the ventral hernia patients reported a similar type of BTP and were given ketorolac, to good effect. All patients were allowed to have hydromorphone up to every 4 hours throughout the night, as needed for BTP. All of the patients were able to ambulate at least once in the evening after the procedure; by the next morning, all were easily ambulating and encouraged to start eating. Most required no hydromorphone, and none required more than a total dose of 1 mg. The next morning, after supplying any additional needed rescue medicine, those patients with epidurals had them removed. In summary, TAP infiltration with EXPAREL as the foundation of a multimodal pain management pathway allowed prolonged relief of the often intense pain experienced by these patients. Overall, the multimodal pain management strategy that included using EXPAREL in TAP infiltrations provided analgesia with a low need for opioids.

Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Please see the full Prescribing Information for EXPAREL.

Dr. Thunga has no financial disclosures to reveal. Dr. Gonzales serves as a consultant for Pacira Pharmaceuticals and SonoSite Inc. Dr. Ayad reported that he has received research support from Abbott Laboratories, Cumberland Pharmaceuticals, and Pacira Pharmaceuticals. He has also served on the speaker’s bureaus at Cadence Pharmaceuticals, Merck & Co., and Pacira Pharmaceuticals. Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Pacira Pharmaceuticals, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form. AP-EXP-031 10-13



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November 2013