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Preoperative Gabapentin for Pelvic Organ Prolapse
Phase 4
Waitlist Available
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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ after surgery, at the time the patient is discharged
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgery, at the time the patient is discharged
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative opioid use
Secondary outcome measures
Anti-emetic use
Mean postoperative pain score
Number of patients that had an adverse event
+7 moreSide effects data
From 2021 Phase 4 trial • 88 Patients • NCT030128152%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine
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
446 Previous Clinical Trials
879,392 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
215 Patients Enrolled for Pelvic Organ Prolapse
Joseph Kowalski, MDPrincipal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am able to understand and give consent for my treatment.I am 18 years old or older.I cannot take acetaminophen, celecoxib, or gabapentinoids due to adverse reactions.I am undergoing or have undergone laparoscopic or abdominal surgery.I am scheduled for a surgery to support the top of my vagina.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How efficacious is Intervention in terms of patient safety?
"The safety of Intervention has been assessed with a score of 3, as this is a Phase 4 trial, suggesting that the treatment has already received approval."
Answered by AI
Are there currently any vacancies available in this research project?
"Clinicaltrials.gov confirms that this study, which was created on January 1st 2023 is not currently recruiting participants. However, there are 199 other clinical trials actively enrolling patients at present."
Answered by AI
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