Clinical trial NCT05658887: Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
Official title: A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Perioperative/Postoperative Complications
Keywords: perioperative pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2022-12-21
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid use
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Mean postoperative pain score
timeFrame: After surgery, max of 24 hours
measure: postoperative opioid use
timeFrame: After surgery, max of 24 hours
measure: Time to discharge
timeFrame: After surgery, at the time the patient is discharged
measure: Anti-emetic use
timeFrame: After surgery, max of 24 hours
measure: Number of patients that had an adverse event
timeFrame: After surgery until 24 hours postoperative
measure: Number of patients who report postoperative dizziness
timeFrame: 24 hours postoperative
measure: Number of patients who report sedation
timeFrame: 24 hours postoperative
measure: Number of patients who report visual changes
timeFrame: 24 hours postoperative
measure: Number of patients who report postoperative nausea and vomiting
timeFrame: 24 hours postoperative
measure: Number of patients who report postoperative pain adequacy
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Joseph Kowalski, MD
role: PRINCIPAL_INVESTIGATOR
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