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

April 11, 2023 updated by: M.D. Anderson Cancer Center
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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
Time Frame: 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
through study completion, up to 8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

January 3, 2023

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0653
  • NCI-2021-10727 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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