At a glance
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A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty
In Brief
A Phase 2 clinical trial evaluating pregabalin and Placebo for CRPS. Completed, enrolled 240 participants.
Detailed Summary
The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA) is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor, including sweating; and movement disorders and dystrophy, including decreased range of motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
Study Details
Timeline
Interventions
PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.