Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

NCT05494385 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OBGYN-IIR-PERI-OP-GABAPENTIN
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Opioid Refill Requests

  6 weeks

• Inpatient Pain Scores

  Length of postoperative hospital stay (an average of 32 hours following surgery)

• Inpatient Morphine Milligram Equivalents

  Length of postoperative hospital stay (an average of 32 hours following surgery)

• Length of Stay

  Time of registration for surgery to time of discharge from hospital

• Nausea

  Length of postoperative hospital stay (an average of 32 hours following surgery)

Study Arms (2)

Preoperative Gabapentin/Postoperative Placebo

PLACEBO COMPARATOR

Drug: Preoperative Gabapentin/Postoperative Placebo

Preoperative Gabapentin/Postoperative Gabapentin

ACTIVE COMPARATOR

Drug: Preoperative Gabapentin/Postoperative Gabapentin

Interventions

Preoperative Gabapentin/Postoperative Placebo DRUG

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.

Preoperative Gabapentin/Postoperative Placebo

Preoperative Gabapentin/Postoperative Gabapentin DRUG

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.

Preoperative Gabapentin/Postoperative Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Anna Guanzon
• Organization: Indiana University School of Medicine

amguanzon89@gmail.com

2197651884

Study Officials

• Douglass S Hale, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Clinical Professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: July 27, 2021
• Primary Completion: June 17, 2023
• Study Completion: July 5, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)