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Withdrawn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
About this trial
This is an interventional supportive care trial for Thoracic
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
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
NCT ID
NCT05100160
First Posted
September 22, 2021
Last Updated
April 11, 2023
Sponsor
M.D. Anderson Cancer Center
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Withdrawn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)
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