Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

NCT05658887 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 202207210
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse; Perioperative/Postoperative Complications

Keywords

perioperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Use

  Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)

  24 hours after surgery. This includes postoperative opioid use in the hospital AND at home (which is why it is different from outcome measure 3).

Secondary Outcomes (11)

• Mean Postop Pain Score

  From the time surgery finished to a max of 24 hours after. This was measured by postoperative nursing periodically throughout the postoperative period per standard nursing protocol: usually every hour for the first two hours and then every 4 to 8 hours

• Postoperative Opioid Use While Admitted in the Hospital

  After surgery, max of 24 hours. Note that this is only postoperative opioid use in the hospital. Outcome measure 1 is total postoperative opioid use (in the hospital and at home)

• Time to Discharge

  Total admitted time (from admission to the hospital to discharge)

• Number of Patients Who Report Postoperative Dizziness

  24 hours postoperative

• Number of Patients Who Report Sedation

  24 hours postoperative

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo

Drug: Gabapentin Placebo

Intervention

EXPERIMENTAL

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Drug: Gabapentin

Interventions

Gabapentin DRUG

One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure

Also known as: FusePaq Fanatrex, Gabarone, Gralise, Neurontin

Intervention

Gabapentin Placebo DRUG

Gabapentin Placebo

Also known as: FusePaq Fanatrex Placebo, Gabarone Placebo, Gralise Placebo, Neurontin Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)
• Female
• Age 18 or higher

You may not qualify if:

• Non-English speaking
• Incarcerated
• Cognitive impairment precluding informed consent
• Chronic opioid user
• Chronic gabapentinoid user
• Contraindication to acetaminophen, celecoxib, or gabapentinoids
• Concurrent laparoscopic or abdominal surgery

Sponsors & Collaborators

• Joseph Kowalski: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Pelvic Organ Prolapse; Postoperative Complications

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Colin Johnson
• Organization: University of Iowa Hospitals and Clinics

colin-johnson@uiowa.edu

3193561616

Study Officials

• Joseph Kowalski, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)