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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 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03123861
The ClinicalTrials.gov registry entry for NCT03123861 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03123861 reports 0 study locations.
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.
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