Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)

Phase 3

Withdrawn

• Conditions: Thoracic; Pulmonary Disease
• Interventions: Other: Placebo; Drug: Gabapentin

• Registration Number: NCT05100160
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)

Detailed Description

Study Objectives:

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.

1. Primary Endpoint

The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.

2. Secondary Endpoints

* Time to resuming normal activities

* Presence/absence of chronic pain at 3 and 6 months, measured by BPI

* 30, 90, 180 day opiate use (Y/N)

* MDASI on post-operative days 7, 30, 90, 180

* Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180

* Daily pain score during hospitalization

* Length of hospital stay

* Need for opioids at discharge

* Whether medication is stopped prior to day 25, and if so when and for what reason.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-29
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18+
• Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
• Must have device with email capabilities for follow up survey

Exclusion Criteria

• Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
• Renal impairment requiring dialysis
• Allergy to Gabapentin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	designed to be compared with a study drug to learn if the study drug has any real effect
Gabapentin	Gabapentin	used as part of a multimodal pain regimen (combination of drugs used to control pain

Primary Outcome Measures

Name	Time	Method
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo	through study completion, up to 8 days	The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States