Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Preoperative Gabapentin/Postoperative Placebo; Drug: Preoperative Gabapentin/Postoperative Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Preoperative Gabapentin/Postoperative Placebo	Drug: Preoperative Gabapentin/Postoperative Placebo; Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Active Comparator: Preoperative Gabapentin/Postoperative Gabapentin	Drug: Preoperative Gabapentin/Postoperative Gabapentin; Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Prescription at Discharge	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.	Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Refill Requests	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.	6 weeks
Inpatient Pain Scores	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.	Length of postoperative hospital stay (an average of 32 hours following surgery)
Inpatient Morphine Milligram Equivalents	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 postoperative hospital stay (an average of 32 hours following surgery)
Length of Stay	Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.	Time of registration for surgery to time of discharge from hospital
Nausea	Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.	Length of postoperative hospital stay (an average of 32 hours following surgery)
Sedation	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.	On postoperative day 1 between 6AM and 10AM

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Douglass S Hale, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): June 17, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Gabapentin
• Other Study ID Numbers: OBGYN-IIR-PERI-OP-GABAPENTIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No