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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-01-03

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Thoracic Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Gabapentin

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Given by PO

Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Given by PO

Interventions

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Gabapentin

Given by PO

Intervention Type DRUG

Placebo

Given by PO

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No