search
Back to results

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

Primary Purpose

Thoracic, Pulmonary Disease

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thoracic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gabapentin

Placebo

Arm Description

used as part of a multimodal pain regimen (combination of drugs used to control pain

designed to be compared with a study drug to learn if the study drug has any real effect

Outcomes

Primary Outcome Measures

The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
April 11, 2023
Sponsor
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05100160
Brief Title
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Official Title
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
0 patient accrual
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic, Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
used as part of a multimodal pain regimen (combination of drugs used to control pain
Arm Title
Placebo
Arm Type
Experimental
Arm Description
designed to be compared with a study drug to learn if the study drug has any real effect
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Given by PO
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Given by PO
Primary Outcome Measure Information:
Title
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
Description
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
Time Frame
through study completion, up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rice
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs