Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05100160 |
Other study ID # |
2021-0653 |
Secondary ID |
NCI-2021-10727 |
Status |
Withdrawn |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 15, 2021 |
Est. completion date |
January 3, 2023 |
Study information
Verified date |
April 2023 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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)
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.