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Studies Assess Impact Of Valdecoxib For Post-Bunionectomy Pain

By Brian McCurdy, Senior Editor
November 2006

     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.

Can Nerve Decompression Provide Pain Relief From Neuropathy?

By Brian McCurdy, Senior Editor Podiatric surgeons have increasingly used peripheral nerve decompression surgery to treat manage painful peripheral neuropathy. Presented as a poster at the American Podiatric Medical Association (APMA) Annual Scientific Meeting, a retrospective study of this procedure concluded that patients experienced relief from pain and the authors feel patients will continue to improve.     Researchers assessed 22 limbs in 16 patients for surgical decompression and neurolysis of the lower extremity. The average follow-up was three to 12 months. Researchers used the Pressure Specified Sensory Device (PSSD, Sensory Management) for neurosensory testing of neuropathy.     Subjective pain scores, as measured by the Visual Analogue Score (VAS), were improved in all patients, according to the study. Authors say patients demonstrated post-op improvements in one-point and two-point static pressure and stance scores. There was also an improvement in two-point static distance postoperatively, according to the study. Emphasizing the importance of this measurement, the study authors say if patients with diabetic neuropathy can significantly decrease the amount of space necessary for cutaneous pressure threshold, they have a significantly decreased chance of developing an ulcer.     The authors say no other study measures the results of decompression in the deep peroneal nerve. They feel the study patients will continue to improve.     In the short term, Stephen Barrett, DPM, says his patients have responded “extremely well” to decompression surgery and in the long term, patient responses have been “absolutely incredible.” Dr. Barrett says nerve surgery comprises about 90 percent of his practice.      “We are very pleased,” notes Dr. Barrett. “Most people who have (the peripheral nerve decompression surgery) done have the other side done.” One disadvantage Dr. Barrett notes is the possibility of improper patient selection for the surgery as this can lead to less than optimal results.

Below The Ankle Frame: A New Option For Calcaneal Fractures?

By Brian McCurdy, Senior Editor Can a below the ankle circular Ilizarov frame adequately treat displaced calcaneal fractures? A recent study in the Journal of Foot and Ankle Surgery examines the effects of the new type of frame. Study authors say combining these frames with minimally invasive fragment reduction techniques may help reduce and stabilize calcaneal fractures.     In the study, authors note that their proposed frame is lightweight and its two rings are confined to the foot. They have thus far treated 19 patients with the below-the-ankle frame and claim the frames achieved and maintained reduction in all patients except one. They note a satisfactory early clinical outcome and say no patients exhibited restriction of ankle joint movement.     The ring mount hangs from a 5/8 reference ring at the level of the talus, notes the study. The authors say three olive wires through the talus and midfoot improve stability of the reference ring. A foot plate attached to the tuberosity with two wires serves as a reduction platform. As the authors point out, placing the rings parallel will correct gross displacement. The study says an olive wire attached to the reference ring holds the reduced articular surface.     Gary Jolly, DPM, says “there may be some real value to not involving the ankle in the construct and allowing it to move during the patient’s convalescence.” However, Dr. Jolly cautions that podiatric surgeons can only use such frames in states where the scope of practice limits conventional frame usage. He also notes that bench top testing is needed in order to clarify the sturdiness of the below ankle frame.      “While traditional frames may be walked on, those which do not include the lower leg have no scientific validity,” says Dr. Jolly, a Fellow and Past President of the American College of Foot and Ankle Surgeons.

DPM Faces Close Call In Beirut Bombings

By Brian McCurdy, Senior Editor A trip to Lebanon turned into a scary experience for one U.S. podiatrist, who found himself caught in the middle of Lebanon’s conflict with Israel. Ali Safiedine, DPM, left in July to visit his wife’s ill grandmother in Beirut. When Dr. Safiedine and his family arrived, the conflict had begun with Israeli bombings in retaliation for the kidnapping of two soldiers.      “Everyone was a little scared but thought that, ‘It’s no big deal. It happens all the time,’” says Dr. Safiedine, who practices in Michigan.     However, during the bombing, he did have to evacuate to the northern end of Beirut, which was supposed to be safer. At 4 a.m., the military again bombed the area in which his mother and sister remained. Dr. Safiedine saw a Lebanon port blown up.      “It was a very scary sight. I was holding my one-year-old daughter,” he recalls. “It was probably the scariest thing I have ever seen in my life.” He and his family gradually made their way back to the United States with help from United Nations employees and a 27-hour bus ride to the Dead Sea in Jordan, a trip that normally lasts five hours.      “I felt worse for them than for us,” he says of his family in America. “Everyone here was just glued to their TVs.”