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Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Sponsor
Joseph Kowalski (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05658887
Collaborator
University of Iowa (Other)
110
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Enhanced Recovery after Surgery (ERAS) is an approach to perioperative care that focuses on evidence-based care protocols that emphasize minimizing stress and improving the body's response to stress. These protocols have resulted in a significant decrease in length of stay, complications, and cost in many different surgical specialities. Many of these protocols (including our current gynecology ERAS protocol) include preoperative gabapentin as an intervention to help reduce postoperative pain and postoperative opioid use. Gabapentin is an anticonvulsant medication that is commonly used for chronic neuropathic pain and other chronic pain disorders. The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited. Notably gabapentin has been shown to be associated with sedation, respiratory depression, dizziness, and visual disturbances. In 2019, the U.S. Food and Drug Administration issued a warning that serious breathing difficulties may occur in patients using gabapentin with respiratory risk factors.

Pelvic organ prolapse is a common benign condition, and surgery for pelvic organ prolapse is very common. Vaginal apical suspension is one of the most common surgeries for pelvic organ prolapse. There is very limited data on the utility of preoperative gabapentin for vaginal apical suspension 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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo

Drug: Gabapentin Placebo
Gabapentin Placebo
Other Names:
  • FusePaq Fanatrex Placebo
  • Gabarone Placebo
  • Gralise Placebo
  • Neurontin Placebo

    		•
    Experimental: Intervention

    Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

    Drug: Gabapentin
    One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
    Other Names:
  • FusePaq Fanatrex
  • Gabarone
  • Gralise
  • Neurontin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative opioid use [24 hours after surgery]

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

    Secondary Outcome Measures

    1. Mean postoperative pain score [After surgery, max of 24 hours]

      Mean postoperative pain score (using the validated numerical rating scale, minimum score 0, maximum score 10, higher scores mean worse pain/worse outcome) while admitted

    2. postoperative opioid use [After surgery, max of 24 hours]

      postoperative opioid use while admitted

    3. Time to discharge [After surgery, at the time the patient is discharged]

      Time (in hours) to discharge after surgery

    4. Anti-emetic use [After surgery, max of 24 hours]

      Postoperative anti-emetic use

    5. Number of patients that had an adverse event [After surgery until 24 hours postoperative]

      Adverse events

    6. Number of patients who report postoperative dizziness [24 hours postoperative]

      Patient reported postoperative dizziness

    7. Number of patients who report sedation [24 hours postoperative]

      Patient reported sedation

    8. Number of patients who report visual changes [24 hours postoperative]

      Patient reported visual changes

    9. Number of patients who report postoperative nausea and vomiting [24 hours postoperative]

      Patient reported postoperative nausea and vomiting

    10. Number of patients who report postoperative pain adequacy [24 hours postoperative]

      Patient reported postoperative pain adequacy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • Female

    • Age 18 or higher

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Joseph Kowalski
    • University of Iowa

    Investigators

    • Principal Investigator: Joseph Kowalski, MD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Joseph Kowalski, Principle Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT05658887
    Other Study ID Numbers:
    • 202207210
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 23, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Joseph Kowalski, Principle Investigator, University of Iowa
    perioperative pain
    Additional relevant MeSH terms:
    Prolapse
    Postoperative Complications
    Pelvic Organ Prolapse
    Gabapentin

    Study Results

    No Results Posted as of Dec 23, 2022