drugset / Trial / NCT03123861

Gabapentin for Postop Pain After SSLF

NCT03123861

Phase 4 Completed 45 enrolled University of North Carolina, Chapel Hill
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and gluteal pain at 7 days after vaginal sacrospinous ligament suspension for apical pelvic organ prolapse. Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent procedures can be performed except total vaginal hysterectomy, colpocleisis, anal sphincteroplasty, fistula surgery, or urethral diverticulectomy Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both groups. Patients will be followed for 6 weeks post-operatively.

Timeline

Start
2017-06-01
Primary completion
2020-07-25
Completion
2020-07-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule 300 mg

Indications