Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05100160
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.
Study:
NCT05100160
Study Brief:
Protocol Section:
NCT05100160