CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03123861
NCT03123861Phase 4Completed

Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse

University of North Carolina, Chapel Hill·interventional·Posted Apr 21, 2017·Updated Oct 26, 2020

In Brief

A Phase 4 clinical trial evaluating Gabapentin and Placebo oral capsule for Pelvic Organ Prolapse. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartJun 1, 2017
Primary CompletionJul 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.2 years ago

Interventions

Gabapentindrug

Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.

Placebo oral capsuledrug

Patients randomized to this arm will receive 2 weeks of placebo post-operatively..