Is perioperative use of a combination of pregabalin and naproxen superior to naproxen only in reducing pain in ankle fractures? A prospective, randomized, multicenter study

Abstract

Purpose: To compare the analgesic efficacy, adverse effects, and long-term functional outcomes of perioperative naproxen alone versus naproxen with pregabalin for treating pain in ankle fractures.

Methods: This study included 70 patients who underwent operative fixation of rotatory ankle fractures. Group A received naproxen 500 mg only, and Group B received naproxen 500 mg with pregabalin 75 mg 2-hour before surgery and 12 hourly for 14 days thereafter. The minimal clinically important difference of the visual analog scale (VAS) for pain was set at 1.8 out of 10. VAS for pain, opioid consumption, and any adverse effects were recorded for 3 days postoperatively. VAS for pain was checked at 2- and 6-weeks and 3- and 6-months, and functional outcomes were measured at 3- and 6-months postoperatively.

Results: Sixty-three patients (33 and 30 in groups A and B, respectively) completed the 6-month follow-up. Demographic data were similar between groups. VAS for pain did not significantly differ between the groups at any timepoint up to 6 months (P ≥ 0.520), with 95% confidence intervals consistently within 1.8. No significant differences were observed between groups in opioid consumption and functional outcomes (P ≥ 0.211). In group B, dizziness at 48-hour and somnolence at 72-hour were significantly predominant (P ≤ 0.05).

Conclusion: Our study demonstrated comparable pain reduction between two groups following operative fixation of rotatory ankle fractures. However, side effects, including dizziness and somnolence, were predominant in Group B between 48 and 72 h.