Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

• Sponsor: Indiana University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05494385
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Preoperative Gabapentin/Postoperative Placebo; Drug: Preoperative Gabapentin/Postoperative Gabapentin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
• Actual Study Start Date: Jul 27, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Opioid Prescription at Discharge [Length of postoperative hospital stay (typically less than 48 hours)]

   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

1. 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.

2. Inpatient Pain Scores [Length of postoperative hospital stay (typically less than 48 hours)]

   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. Pain score collected will be pain recorded at 12 hours after arrival to the floor and highest score during hospital stay

3. Inpatient Morphine Milligram Equivalents [Length of postoperative hospital stay (typically less than 48 hours)]

   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.

4. Length of Stay [Length of postoperative hospital stay (typically less than 48 hours)]

   Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.

5. Nausea [Length of postoperative hospital stay (typically less than 48 hours)]

   Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.

6. Sedation [Length of postoperative hospital stay (typically less than 48 hours)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Douglass Hale, Adjunct Clinical Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT05494385
• Other Study ID Numbers: OBGYN-IIR-PERI-OP-GABAPENTIN
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pain, Postoperative; Gabapentin

Study Results

No Results Posted as of Aug 10, 2022