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NCT03123861 · ClinicalTrials.gov registry record · Phase 4
Gabapentin for Postop Pain After SSLF
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT03123861: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT03123861 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123861, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study 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.
Primary Outcome
Post-operative pain at week 1 will be measured by item 2 of the surgical pain scale (SPS). This item asks for the average amount of pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain.
Interventions
- DRUG Placebo oral capsule
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-07-25 |
| Phase | Phase 4 |
What the finished NCT03123861 record still lists
NCT03123861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03123861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03123861 about?
NCT03123861 is a clinical study titled "Gabapentin for Postop Pain After SSLF". 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 ...
What is the current status of trial NCT03123861?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2017-06-01. Estimated completion is 2020-07-25.
What interventions are being tested in trial NCT03123861?
The interventions under investigation include: Placebo oral capsule (DRUG), Gabapentin (DRUG).
Who is sponsoring clinical trial NCT03123861?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123861's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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