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NCT05658887 · ClinicalTrials.gov registry record · Phase 4
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
A Phase 4 study of Pelvic Organ Prolapse and Perioperative/Postoperative Complications, sponsored by Joseph Kowalski.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT05658887: Completed Phase 4 study of Pelvic Organ Prolapse and Perioperative/Postoperative Complications, sponsored by Joseph Kowalski.
NCT05658887 is a Phase 4 study of Pelvic Organ Prolapse and Perioperative/Postoperative Complications that has completed, run by Joseph Kowalski. The registered enrollment target is 110 participants, below the 142-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05658887, a Phase 4 study of Pelvic Organ Prolapse and Perioperative/Postoperative Complications, has completed, sponsored by Joseph Kowalski.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.
Primary Outcome
Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)
Conditions Studied
Interventions
- DRUG Gabapentin
- DRUG Gabapentin Placebo
Study Locations (1)
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
What the finished NCT05658887 record still lists
NCT05658887 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (23% lower).
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Gabapentin is the first listed.
NCT05658887 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT05658887 about?
NCT05658887 is a clinical study titled "Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery". This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperati...
What is the current status of trial NCT05658887?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2023-01-01. Estimated completion is 2024-12-31.
What conditions does trial NCT05658887 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Perioperative/Postoperative Complications.
What interventions are being tested in trial NCT05658887?
The interventions under investigation include: Gabapentin (DRUG), Gabapentin Placebo (DRUG).
Who is sponsoring clinical trial NCT05658887?
This trial is sponsored by Joseph Kowalski, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05658887 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05658887's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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