Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Preoperative Gabapentin/Postoperative Gabapentin; Drug: Preoperative Gabapentin/Postoperative Placebo

• Registration Number: NCT05494385
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-27
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Primary Completion: 2023-06-17
• Study Completion: 2023-07-05
• Results First Submitted: 2024-07-22
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• Women > 18 years old
• English-speaking
• Stage > 2 pelvic organ prolapse
• Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
• Planning overnight stay

Exclusion Criteria

• Renal dysfunction (creatinine clearance <60 mL/min)
• Allergy to acetaminophen and ibuprofen
• Allergy to gabapentin
• Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative Gabapentin/Postoperative Gabapentin	Preoperative Gabapentin/Postoperative Gabapentin	-
Preoperative Gabapentin/Postoperative Placebo	Preoperative Gabapentin/Postoperative Placebo	-

Primary Outcome Measures

Name	Time	Method
Opioid Prescription at Discharge	Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)	Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.

Secondary Outcome Measures

Name	Time	Method
Opioid Refill Requests	6 weeks	Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Inpatient Pain Scores	Length of postoperative hospital stay (an average of 32 hours following surgery)	Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded.
Inpatient Morphine Milligram Equivalents	Length of postoperative hospital stay (an average of 32 hours following surgery)	Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Length of Stay	Time of registration for surgery to time of discharge from hospital	Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Nausea	Length of postoperative hospital stay (an average of 32 hours following surgery)	Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
Sedation	On postoperative day 1 between 6AM and 10AM	Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States