Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT05100160
Status:
WITHDRAWN
Last Update Posted:
2023-04-13
First Post:
2021-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
0 patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-10727 | OTHER | NCI-CTRP Clinical Trials Reporting Registry | View |