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Preoperative Gabapentin for Pelvic Organ Prolapse

Phase 4
Recruiting
Led By Joseph Kowalski, MD
Research Sponsored by Joseph Kowalski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours postoperative
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare preoperative gabapentin to placebo for reducing post-op opioid use in women undergoing vaginal apical suspension surgery.

Who is the study for?
This trial is for women over 18 who are scheduled for vaginal prolapse surgery (sacrospinous ligament fixation or uterosacral ligament suspension). It's not open to chronic users of gabapentinoids, opioids, those with cognitive impairments, non-English speakers, incarcerated individuals, or anyone with a contraindication to acetaminophen, celecoxib, or gabapentinoids.
What is being tested?
The study tests if preoperative Gabapentin reduces post-surgery opioid use compared to a placebo. Women will be randomly assigned either Gabapentin or a placebo in addition to standard pain management before their prolapse surgery. Both the patients and researchers won't know who receives which treatment.
What are the potential side effects?
Gabapentin may cause side effects such as dizziness, fatigue, visual changes and swelling of limbs. Since it's given preoperatively here, immediate postoperative side effects like sedation could also be relevant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgery, at the time the patient is discharged
This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgery, at the time the patient is discharged for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative opioid use
Secondary study objectives
Anti-emetic use
Mean postoperative pain score
Number of patients that had an adverse event
+7 more

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Preoperative tylenol, preoperative celecoxib, preoperative gabapentin
Group II: PlaceboPlacebo Group1 Intervention
Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

Joseph KowalskiLead Sponsor
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
44 Patients Enrolled for Pelvic Organ Prolapse
University of IowaOTHER
468 Previous Clinical Trials
893,381 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
215 Patients Enrolled for Pelvic Organ Prolapse
Joseph Kowalski, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Preoperative Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05658887 — Phase 4
Pelvic Organ Prolapse Research Study Groups: Intervention, Placebo
Pelvic Organ Prolapse Clinical Trial 2023: Preoperative Gabapentin Highlights & Side Effects. Trial Name: NCT05658887 — Phase 4
Preoperative Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658887 — Phase 4
~5 spots leftby Dec 2024
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