Epidural Steroid Injection Paralyzes Woman at Denver ASC
OFF-LABEL USE The FDA warned against using Kenalog for epidurals in 2011.

The case of a 60-year-old woman paralyzed from the waist down after receiving an epidural injection of Kenalog at a Denver surgical center has reignited the debate over the off label use of corticosteroids.

Epidural steroid injections are the most common procedure doctors perform for low back pain — done nearly 9 million times a year. But the FDA has never approved epidural steroid injections for spinal use (they're approved for muscles and joints). The agency warns that the "off label" use of corticosteroids — which the agency considers "part of the practice of medicine and not regulated by FDA" — may result in rare but serious adverse events, including loss of vision, stroke, paralysis and death.

Robin Smith walked into The Surgery Center at Lone Tree in Denver, Colo., on Sept. 9, 2013, for an epidural steroid injection to treat a balky back in time for her son's wedding. She was wheeled out a few hours later, paralyzed from the waist down after a Kenalog injection resulted in spinal cord infarction. A jury this month awarded Ms. Smith $14.9 million, the second largest medical negligence verdict in Colorado history.

Ms. Smith, 60, received 4 injections on the right side of vertebrae L1 and L2, according to her attorney, Bruce Braley. Soon after the final injection, in the recovery area, Ms. Smith lost motor function and complete sensation from the waist down, he says. She was rushed to a local hospital for testing and was eventually transferred to a long-term rehabilitation center. Ms. Smith never made it to her son's wedding.

Bristol Myers changed Kenalog's label, packaging and insert in 2011 to warn against using the corticosteroid for epidurals. The label change also warned of potential related complications, including spinal cord infarction, paraplegia, quadriplegia and cortica. Ms. Smith's care team did not alert her about the potential adverse reactions, says Mr. Braley.

"The surgery center's policy requires members of the nursing staff to read a medication label 4 times before administering the agent," says Mr. Braley. "Based on the number of cases the center hosts per year, they would have read Kenalog's warning more than 20,000 times since the label change."

Spine One, a Denver-based management firm, owns The Surgery Center at Lone Tree. Mr. Braley says Perry Haney, MD, the medical director at Spine One, testified at the trial and said he was not aware of the label change and that the company does not dictate how physicians practice on a daily basis.

"This case sends a strong message to surgery centers that there are specific regulations they need to follow and have the responsibility to oversee how medical procedures are performed and the drugs used," says Mr. Braley. "They can't ignore the reality of a changing clinical environment as research evolves and concerns about specific medications are made public."

In 2014, the FDA mandated that all injectable glucocorticoid product labels carry a label warning of "serious neurologic events" associated with the epidural injection of corticosteroids and that the agents have not been approved for this use, according to a report in the December 2015 issue of the New England Journal of Medicine. The authors note, "We believe that it is important to warn patients and practitioners about the risk of these serious, albeit rare, adverse events and to remind providers that epidural injection is an off-label use of glucocorticoids."

Kevin Kuhn, the attorney for The Surgery Center at Lone Tree, declined to comment.

Daniel Cook

A Pharmaceutical Cure for Hypothermia?
HOT STORY Early research suggests the benefits of a TRPV1 antagonist may include quicker recovery times and wound healing, as well as less post-operative pain without the use of opioids.

Researchers believe a pharmaceutical agent originally intended to target pain may hold the key to preventing anesthesia-induced hypothermia.

TRPV1 is a pain receptor in the human body activated by "dangerous" outside stimuli, such as hot temperatures. Pharmaceutical companies first saw potential in TRPV1 antagonists to be used as analgesics, but those plans were scuttled when the drugs produced fever-like symptoms in patients. Researchers from the University of Arizona College of Medicine in Tucson and St. Joseph's Hospital and Medical Center in Phoenix now say TRPV1 antagonists may help to revolutionize the way ORs treat the effects of hypothermia.

"Here's a drug which is potentially pain medication, but which also reverses body temperature, which is dropped under anesthesia," Dr. Patwardhan, an anesthesiologist and assistant professor of pharmacology and anesthesiology at the University of Arizona in Tucson, told The Daily Wildcat. "In one hand you can get 2 results, both of which are highly desirable under anesthesia."

Although an TRPV1 antagonist has been tested only on rats so far, it could have "big advantages" for human patients, said Dr. Porreca, a professor of anesthesiology and pharmacology at UA — namely, quicker recovery times, more efficient wound healing and minimized pain without the use of opioids, all while mitigating the potentially dangerous effects of hypothermia.

Through their new start-up, Catalina Pharma, the researchers are now working on getting clinical trials underway.

Bill Donahue

Prehabbing Produces Better Surgical Outcomes
ON THE MOVE Light walking improves blood flow and speeds healing.

Patients who walk an hour a day in the weeks leading up to surgery recover from surgery faster and help lower overall healthcare costs, according to University of Michigan researchers, who say convincing patients to adopt healthy lifestyles should be given the same priority as other pre-op protocols.

The researchers recently assessed the outcomes of 641 patients who underwent elective procedures after participating in the Michigan Surgical and Health Optimization Program (MSHOP), a home-based program created at the University of Michigan to help patients become physically and mentally stronger before undergoing surgery. Patients were asked to complete light physical activity, eat healthy, reduce their stress levels, complete breathing exercises and quit smoking. The program reduced length of post-op hospitalizations by 2 days and sliced a third off the cost of care, according to the study.

Patients received daily positive reminders via text or automated phone calls to complete the walking regimens. The intervention contributed to 82% of the patients being actively engaged in the program, meaning they recorded physical activity at least 3 times per week, according to the researchers.

Physical and mental strength dictates how well patients recover from the controlled injury of surgery, according to Stewart Wang, MD, PhD, FACS, one of the creators of MSHOP and co-author of the study. But despite the positive impact that prehabbing has on post-op results, concerns about the amount of work it takes to implement the regimen have prevented more surgeons from embracing the concept. That hasn't deterred the Michigan researchers, who say MSHOP is scalable and could be tailored to address the prehab needs of individual patients undergoing specific procedures such as joint replacement surgery.

"Expected complications or recovery difficulties could be addressed in advance with targeted training," says Dr. Wang. "This is just the beginning."

Daniel Cook

InstaPoll: Separate Consent Forms for Surgery and Anesthesia?

Tell us in this week's InstaPoll if you have separate informed consent forms for surgery and anesthesia or if a single form covers both.

Nearly 4 out of 5 (79%) of the 315 respondents to last week's InstaPoll feel that U.S. lawmakers should make surgical smoke evacuation mandatory. The results:

Should U.S. lawmakers make surgical smoke evacuation mandatory?

  • strongly agree 63%
  • agree 16%
  • neutral 8%
  • disagree 7%
  • strongly disagree 6%

Dan O'Connor

News & Notes
  • OR Excellence free book offer Best-selling author and internationally renowned speaker Kathleen Bartholomew, RN, MN, returns to OR Excellence in October to dare you to be bold, intrepid and courageous when advocating for your patients. The next 50 people to register for OR Excellence will receive a complimentary signed copy of Ms. Bartholomew's book, The Dauntless Nurse: Communication Confidence Builder. Ms. Bartholomew is also the author of Speak Your Truth: Proven Strategies for Effective RN-MD Communication and the bestselling Ending Nurse-to-Nurse Hostility.
  • Is single-dose IV acetaminophen effective for managing post-op pain? In an observational study of 229 children undergoing outpatient ENT procedures, single-dose IV acetaminophen had limited efficacy in decreasing patients' perioperative or post-operative pain. The study, which was conducted by researchers from University of Michigan Medical School in Ann Arbor, found that 43.7% of patients who received a single dose of IV acetaminophen required analgesic intervention in the PACU. Also, patients who received IV acetaminophen had significantly higher rates of intraoperative opioid use (98%) compared with those who received multimodal analgesia.
  • Reduce SSIs in colon and rectal surgeries Combining oral antibiotics the day before surgery with perioperative administration of IV antibiotics reduced the risk of open-space surgical site infections in both colon and rectal surgeries, according to a new study in Antimicrobial Resistance and Infection Control. The researchers say performing the surgeries laparoscopically also lowers risk of post-op infection.