Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05658887

Enrollment

110

Registered

2022-12-21

Start date

2023-01-01

Completion date

2024-12-31

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Perioperative/Postoperative Complications

Keywords

perioperative pain

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.

Interventions

DRUGGabapentin

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

DRUGGabapentin Placebo

Gabapentin Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Visual Changes	24 hours postoperative	Patient reported visual changes
Number of Patients Who Report Sedation	24 hours postoperative	Patient reported sedation
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	—
Number of Patients Who Report Postoperative Nausea	24 hours postoperative	Patient reported postoperative nausea and vomiting

Countries

United States

Participant flow

Recruitment details

110 people completed informed consent. 3 people withdrew or were disqualified prior to being randomized which is why only 107 were randomized.

Participants by arm

Arm	Count
Placebo Preoperative tylenol, preoperative celecoxib, preoperative placebo Gabapentin Placebo: Gabapentin Placebo	50
Intervention Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure	50
Total	100

Baseline characteristics

Characteristic	Placebo	Intervention	Total
Age, Continuous	61 years	67 years	65 years
Baseline Vaginal Estrogen Use	15 Participants	13 Participants	28 Participants
Body Mass Index (BMI)	28.9 kg/m^2	28.3 kg/m^2	28.5 kg/m^2
Current Tobacco Use	4 Participants	8 Participants	12 Participants
Diabetes	4 Participants	9 Participants	13 Participants
Pelvic Organ Prolapse Quantification (POP-Q) Stage	2 Stage	3 Stage	2 Stage
Preoperative Pain Score of 0	46 Participants	39 Participants	85 Participants
Prior Hysterectomy	12 Participants	13 Participants	25 Participants
Prior Pelvic Organ Prolapse (POP) Surgery	2 Participants	2 Participants	4 Participants
Prior Stress Urinary Incontinence (SUI) Surgery	3 Participants	1 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	48 Participants	49 Participants	97 Participants
Region of Enrollment United States	50 participants	50 participants	100 participants
Sex: Female, Male Female	50 Participants	50 Participants	100 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Vaginal Atrophy	34 Participants	43 Participants	77 Participants
Vaginal Parity	2 Vaginal Deliveries	3 Vaginal Deliveries	2.5 Vaginal Deliveries

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 50	0 / 50
other Total, other adverse events	21 / 50	16 / 50
serious Total, serious adverse events	0 / 50	0 / 50

Outcome results

Primary

Postoperative Opioid Use

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

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).

Arm	Measure	Value (MEDIAN)
Placebo	Postoperative Opioid Use	25 MMEs
Intervention	Postoperative Opioid Use	20 MMEs

Secondary

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

Arm	Measure	Value (MEDIAN)
Placebo	Estimated Blood Loss	25 mL
Intervention	Estimated Blood Loss	50 mL

Secondary

Mean Postop 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 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)

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

Arm	Measure	Value (MEDIAN)
Placebo	Mean Postop Pain Score	3.5 Pain Score
Intervention	Mean Postop Pain Score	3.25 Pain Score

Secondary

Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids

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

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

Arm	Measure	Value (MEDIAN)
Placebo	Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids	46 Morphine milligram equivalents (MMEs)
Intervention	Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids	40 Morphine milligram equivalents (MMEs)

Secondary