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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• 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
• 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease
• Thoracic

Intervention

Drug:
• Gabapentin
Given by PO

Other:
• Placebo
Given by PO

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center