Studies Assess Impact Of Valdecoxib For Post-Bunionectomy Pain
When patients have pain after a bunionectomy procedure, what are the best options for providing pain relief? Two randomized, double-blind, placebo-controlled studies, recently published in the Journal of the American Podiatric Medical Association, note that patients who took valdecoxib (Bextra, Pfizer) following bunionectomies experienced pain relief. In the first study, researchers evaluated 374 bunionectomy patients. On the first post-op day, one group took 40 mg of valdecoxib followed one to 12 hours later by 20 mg of the drug. The second group took 40 mg of valdecoxib followed by placebo. The third group only took a placebo. The second study assessed 478 patients on post-op days two through five. One group took 20 mg of valdecoxib twice a day. The second group took 20 mg of valdecoxib once a day. The third group only took a placebo. Researchers concluded that valdecoxib provided “significant pain relief,” higher patient satisfaction and lowered the use of opioid rescue medicine. The authors completed the studies before Pfizer suspended U.S. sales of Bextra in May 2005. Co-author Richard M. Jay, DPM, says the team presented the information at the American Society of Anesthesiologists Annual Meeting just as the news broke about Bextra. At that time, the FDA recommended placing a black box warning on all nonsteroidal antiinflammatory drugs (NSAIDs) that noted “a potential increased risk of serious adverse cardiovascular events.”
What Have DPMs Experienced When Using Valdecoxib?
How does valdecoxib compare to other drugs as far as analgesic effect? Although Jeffrey Boberg, DPM, has used valdecoxib in the past, he says it would be difficult to gauge the drug’s effectiveness, noting that some patients have a lot of post-op pain and some have little pain. He also notes difficulty in comparing valdecoxib to other drugs because most patients undergo different or multiple procedures. “Aside from QD or BID dosage, I am not sure that Bextra has much of an advantage over any other NSAID,” opines Dr. Boberg, the Director of Residency Training at the Forest Park Hospital in St. Louis. Dr. Boberg believes there was a push to create a niche for Bextra as a post-op analgesic. He says it would have been interesting for a study to compare valdecoxib to naprosyn rather than to a placebo. However, Dr. Boberg does note the well-documented effects of antiinflammatory medicines in reducing post-op pain. He notes the documented positive effects of injected cortisone, ketorolac tromethamine (Toradol, Roche U.S. Pharmaceuticals) and adds that naproxen (Aleve, Naprosyn) has shown similar analgesic potency to Tylenol with codeine. He has had the best results with Toradol, which one can give IV during surgery and PO in the post-op period. As Dr. Boberg says, narcotics alter mood, have a potential for drug interaction and can cause dependency, while NSAIDS, including COX-2 inhibitors, may have some deleterious effects on bone healing. Patrick DeHeer, DPM, does not routinely use any type of NSAID with hallux abducto valgus surgery, saying he has “not seen the need to do so.” He believes NSAIDs may be of more help for patients who undergo larger rearfoot procedures as they may have more pain and swelling. “I have not used this (valdecoxib) much in my practice,” says Dr. DeHeer, a Fellow of the American College of Foot and Ankle Surgeons. “It has been my experience with postoperative pain that most patients respond better to a narcotic type of pain medication compared to non-narcotic pain medications.” “I continued to use Bextra postoperatively and found that my use in clinical practice mirrored the efficacy as determined by the study,” says Dr. Jay, a Professor of Foot and Ankle Orthopedics at the Temple University School of Podiatric Medicine.