Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Organ Prolapse, Perioperative/Postoperative Complications

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Gabapentin Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo | Drug: Gabapentin Placebo<br>* Gabapentin Placebo<br>* Other names: Neurontin Placebo;|
| Experimental: Intervention<br>Preoperative tylenol, preoperative celecoxib, preoperative gabapentin | Drug: Gabapentin<br>* One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postoperative pain score | 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 | After surgery, max of 24 hours | 
| postoperative opioid use | postoperative opioid use while admitted | After surgery, max of 24 hours | 
| Time to discharge | Time (in hours) to discharge after surgery | After surgery, at the time the patient is discharged | 
| Anti-emetic use | Postoperative anti-emetic use | After surgery, max of 24 hours | 
| Number of patients that had an adverse event | Adverse events | After surgery until 24 hours postoperative | 
| Number of patients who report postoperative dizziness | Patient reported postoperative dizziness | 24 hours postoperative | 
| Number of patients who report sedation | Patient reported sedation | 24 hours postoperative | 
| Number of patients who report visual changes | Patient reported visual changes | 24 hours postoperative | 
| Number of patients who report postoperative nausea and vomiting | Patient reported postoperative nausea and vomiting | 24 hours postoperative | 
| Number of patients who report postoperative pain adequacy | Patient reported postoperative pain adequacy | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative pain