Trial Outcomes & Findings for Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery (NCT NCT05658887)

NCT ID: NCT05658887

Last Updated: 2025-08-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 110 participants
• Primary outcome timeframe: 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).
• Results posted on: 2025-08-12

Participant Flow

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

Participant milestones

Measure	Placebo Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Overall Study STARTED	52	55
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Baseline characteristics by cohort

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure	Total n=100 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	67 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Body Mass Index (BMI)	28.9 kg/m^2 n=5 Participants	28.3 kg/m^2 n=7 Participants	28.5 kg/m^2 n=5 Participants
Vaginal Parity	2 Vaginal Deliveries n=5 Participants	3 Vaginal Deliveries n=7 Participants	2.5 Vaginal Deliveries n=5 Participants
Current Tobacco Use	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Diabetes	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Prior Hysterectomy	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Prior Pelvic Organ Prolapse (POP) Surgery	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Prior Stress Urinary Incontinence (SUI) Surgery	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Pelvic Organ Prolapse Quantification (POP-Q) Stage	2 Stage n=5 Participants	3 Stage n=7 Participants	2 Stage n=5 Participants
Vaginal Atrophy	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Baseline Vaginal Estrogen Use	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Preoperative Pain Score of 0	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Postoperative Opioid Use	25 MMEs Interval 13.0 to 45.0	20 MMEs Interval 8.0 to 35.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Mean Postop Pain Score	3.5 Pain Score Interval 2.0 to 4.8	3.25 Pain Score Interval 2.0 to 4.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Postoperative Opioid Use While Admitted in the Hospital	20 MMEs Interval 5.0 to 36.0	16 MMEs Interval 5.0 to 25.0

SECONDARY outcome

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

Admitted time

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Time to Discharge	528 minutes Interval 459.0 to 678.0	542 minutes Interval 477.0 to 1394.0

SECONDARY outcome

Timeframe: 24 hours postoperative

Patient reported postoperative dizziness

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Number of Patients Who Report Postoperative Dizziness	13 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 hours postoperative

Patient reported sedation

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Number of Patients Who Report Sedation	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 hours postoperative

Patient reported visual changes

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Number of Patients Who Report Visual Changes	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours postoperative

Patient reported postoperative nausea and vomiting

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Number of Patients Who Report Postoperative Nausea	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 24 hours postoperative

Patient reported postoperative pain adequacy

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Number of Patients Who Report Postoperative Pain Adequacy	40 Participants	41 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids	46 Morphine milligram equivalents (MMEs) Interval 42.0 to 74.0	40 Morphine milligram equivalents (MMEs) Interval 34.0 to 55.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Estimated Blood Loss	25 mL Interval 0.0 to 75.0	50 mL Interval 10.0 to 50.0

SECONDARY outcome

Timeframe: During surgery

Outcome measures

Measure	Placebo n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 Participants Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Surgery Length	152 Minutes Interval 127.0 to 170.0	147 Minutes Interval 110.0 to 165.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=50 participants at risk Preoperative tylenol, preoperative celecoxib, preoperative placebo Gabapentin Placebo: Gabapentin Placebo	Intervention n=50 participants at risk Preoperative tylenol, preoperative celecoxib, preoperative gabapentin Gabapentin: One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Nervous system disorders Participant Reported Dizziness	26.0% 13/50 • 36 hours after surgery	14.0% 7/50 • 36 hours after surgery
Nervous system disorders Patient Reported Sedation	8.0% 4/50 • 36 hours after surgery	4.0% 2/50 • 36 hours after surgery
Nervous system disorders Patient Reported Visual Changes	2.0% 1/50 • 36 hours after surgery	2.0% 1/50 • 36 hours after surgery
Gastrointestinal disorders Patient Reported Nausea	28.0% 14/50 • 36 hours after surgery	20.0% 10/50 • 36 hours after surgery

Additional Information

Dr. Colin Johnson

University of Iowa Hospitals and Clinics

Phone: 3193561616

Email: colin-johnson@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place