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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05100160
• Collaborator: (none)
• Enrollment: 448
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Thoracic; Pulmonary Disease	Drug: Gabapentin; Other: Placebo	Phase 3

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.

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 448 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
• Anticipated Study Start Date: Jul 31, 2023
• Anticipated Primary Completion Date: Jul 31, 2030
• Anticipated Study Completion Date: Jul 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin used as part of a multimodal pain regimen (combination of drugs used to control pain	Drug: Gabapentin; Given by PO
Experimental: Placebo designed to be compared with a study drug to learn if the study drug has any real effect	Other: Placebo; Given by PO

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: David Rice, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05100160
• Other Study ID Numbers: 2021-0653; NCI-2021-10727
• First Posted: Oct 29, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Gabapentin

Study Results

No Results Posted as of Jul 12, 2022