Randomized Clinical Trial of Gabapentin Versus Placebo for Pain After Sacrospinous Ligament Fixation

Abstract

Given the risk of postoperative pain and specifically neuropathic gluteal pain after a sacrospinous ligament suspension, we conducted a randomized trial to compare a 2-week course of gabapentin versus placebo on postoperative pain after a sacrospinous ligament fixation. This double-blinded, randomized, placebo-controlled trial compared 2 weeks of gabapentin (300 mg nightly for 3 days and then 300 mg twice a day for 11 days) versus identical-appearing placebo after a sacrospinous ligament fixation procedure. The primary outcome was participant-reported average pain during normal activity in the past 24 hours (score 0-10 on the validated Surgical Pain Scale) assessed on postoperative day (POD) 7. We also assessed average pain at rest and gluteal (buttocks) pain (score 0-10). We needed 17 participants per group to detect a 2.5-point difference in Surgical Pain Scale score with an SD of 2.6 (α = 0.05; power, 80%). The final intention-to-treat analysis compared 19 (49%) in the gabapentin group versus 20 (51%) in the placebo group. Between the gabapentin and placebo groups, average pain (2.0 ± 2.0 vs 3.4 ± 2.8, P = 0.09, respectively) and gluteal pain (2.1 ± 2.0 vs 3.4 ± 2.4, P = 0.09) during normal activity on POD 7 were not significantly different. However, average pain at rest on POD 7 was lower with gabapentin (1.6 ± 1.5 vs 3.2 ± 2.6, P = 0.04). Although a 2-week course of gabapentin did not significantly decrease overall pain with normal activity after a sacrospinous ligament fixation procedure, pain at rest was lower with gabapentin compared with placebo.