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Completed

NCT Number: NCT05658887

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 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.

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Key information

Conditions

Pelvic Organ Prolapse Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

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

Other names: FusePaq Fanatrex, Gabarone, Gralise, Neurontin

Gabapentin Placebo

Drug

Gabapentin Placebo

Other names: FusePaq Fanatrex Placebo, Gabarone Placebo, Gralise Placebo, Neurontin Placebo

Primary outcomes

  1. Postoperative Opioid Use

    Time frame: 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).

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

Secondary outcomes

  1. Mean Postop Pain Score

    Time frame: 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

    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 in the hospital. Note: this is the mean score while they were postoperatively but median below is correct because we used the median of each individual's MEAN score (this is addressing the comment #10)

  2. Postoperative Opioid Use While Admitted in the Hospital

    Time frame: 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)

    postoperative opioid use while admitted

  3. Time to Discharge

    Time frame: Total admitted time (from admission to the hospital to discharge)

    Admitted time

  4. Number of Patients Who Report Postoperative Dizziness

    Time frame: 24 hours postoperative

    Patient reported postoperative dizziness

  5. Number of Patients Who Report Sedation

    Time frame: 24 hours postoperative

    Patient reported sedation

  6. Number of Patients Who Report Visual Changes

    Time frame: 24 hours postoperative

    Patient reported visual changes

  7. Number of Patients Who Report Postoperative Nausea

    Time frame: 24 hours postoperative

    Patient reported postoperative nausea and vomiting

  8. Number of Patients Who Report Postoperative Pain Adequacy

    Time frame: 24 hours postoperative

    Patient reported postoperative pain adequacy

  9. Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids

    Time frame: Preop period to the end of the surgery (any opioids given to the patient from arrival in the hospital to the end of the surgery), on average 5 hours

    Amount of opioids (in MMEs) given before and during the surgery

  10. Estimated Blood Loss

    Time frame: During the surgery (from surgery start time to surgery end time, this was assessed at the end of the surgery while in the OR), on average 150 minutes

  11. Surgery Length

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

Joseph Kowalski

Other

Collaborators

  • University of Iowa

Registry information

Official study title

A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2022
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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