NCT05100160

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic
• Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Gabapentin	Given by PO
OTHER	Placebo	Given by PO

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-01-03
• Completion: 2023-01-03
• First posted: 2021-10-29
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study