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

Study Overview
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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)

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. 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.

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

Conditions
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Pulmonary Disease, Thoracic

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>used as part of a multimodal pain regimen (combination of drugs used to control pain | Drug: Gabapentin<br>* Given by PO<br>|
| Experimental: Placebo<br>designed to be compared with a study drug to learn if the study drug has any real effect | Other: Placebo<br>* Given by PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, up to 8 days |