Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Phase 4

Completed

Conditions: Pelvic Organ Prolapse
Perioperative/Postoperative Complications

Interventions: Drug: Gabapentin Placebo
Drug: Gabapentin

Registration Number: NCT05658887

Lead Sponsor: Joseph Kowalski

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 110

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Gabapentin Placebo	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo
Intervention	Gabapentin	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Primary Outcome Measures

Name	Time	Method
Postoperative Opioid Use	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 Outcome Measures

Name	Time	Method
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	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)
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)	postoperative opioid use while admitted
Time to Discharge	Total admitted time (from admission to the hospital to discharge)	Admitted time
Number of Patients Who Report Postoperative Dizziness	24 hours postoperative	Patient reported postoperative dizziness
Number of Patients Who Report Sedation	24 hours postoperative	Patient reported sedation
Number of Patients Who Report Visual Changes	24 hours postoperative	Patient reported visual changes
Number of Patients Who Report Postoperative Nausea	24 hours postoperative	Patient reported postoperative nausea and vomiting
Number of Patients Who Report Postoperative Pain Adequacy	24 hours postoperative	Patient reported postoperative pain adequacy
Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids	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
Estimated Blood Loss	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
Surgery Length	During surgery