An NSAID Pain Protocol Provides Adequate Pain Relief in Ankle Fractures Treated Operatively

Rationale: Opioid abuse is rampant, can have bad consequences, and is a source of many individual and societal problems. Although its use fulfills a role in pain control, this investigation seeks to find a pain control alternative with the potential for fewer adverse consequences for patient undergoing surgery for ankle fracture.

Hypothesis: A structured regimen of NSAIDs (drugs such as ibuprofen or naproxen) during and after ankle fracture surgery will provide adequate pain relief and cause patients to take fewer doses of opioid drugs.

Methods: This will be a prospective, randomized, double-blinded, placebo controlled study of patients with ankle fractures who require surgical treatment by several NSLIJ orthopaedic surgeons at North Shore University Hospital and Long Island Jewish Medical Center. There will be two groups of patients: one getting NSAIDs to take at regularly scheduled times plus a traditional prescription for opioid medication and one receiving the traditional prescription for opioid medication and a placebo. Patients will be assigned to a group from a computer-generated program. Neither the patients nor their doctors or nurses will know what group they are in, only the pharmacist will have that information. Patients in both groups will have the opportunity to take opioid medications if the pain becomes unmanageable. We are evaluating whether patients in the NSAIDs group will a) have no more pain than patients who are prescribed opioid pain killers for the same surgery and b) if the amount of opioid pain killers can be reduced by having patients take scheduled doses of NSAIDs. We will also describe how well or poorly patients heal, looking at several timepoints after surgery, using Xrays to evaluate formation of new bone.

The test (experimental) group will be given a dose of IV (intravenous) ketorolac, which is an NSAID, during surgery, and will be given naproxen 500mg orally two times per day to take on a regular basis after surgery for four weeks. This group will be given percocet 5/325 (an opioid medication) 1-2 pills orally every 4 hours to take as pain medication if the naproxen is not providing adequate pain relief.

The control group will be administered a saline dose during surgery as an equivalent to the IV ketorolac. These patients will take placebo pain pills on a regular basis two times per day for four weeks, and will take percocet for pain relief. This is equivalent to the common pain protocol that is given to patients after ankle fracture surgery, where they are given percocet to be taken on an as-needed basis.