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NCT05494385 · ClinicalTrials.gov registry record · Phase 4
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
NCT05494385: Completed Phase 4 study, sponsored by Indiana University.
NCT05494385 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 114 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05494385, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
Primary Outcome
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Interventions
- DRUG Preoperative Gabapentin/Postoperative Placebo
- DRUG Preoperative Gabapentin/Postoperative Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 4 |
What the finished NCT05494385 record still lists
NCT05494385 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Preoperative Gabapentin/Postoperative Placebo is the first listed.
NCT05494385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05494385 about?
NCT05494385 is a clinical study titled "Effect of Perioperative Gabapentin on Postoperative Opioid Requirements". The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
What is the current status of trial NCT05494385?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2021-07-27. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT05494385?
The interventions under investigation include: Preoperative Gabapentin/Postoperative Placebo (DRUG), Preoperative Gabapentin/Postoperative Gabapentin (DRUG).
Who is sponsoring clinical trial NCT05494385?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05494385's enrollment target sits among peer trials
114 720th of 2000 higher than 1,278 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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