Clinical trial NCT05100160: Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Official title: Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Thoracic
Pulmonary Disease
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
timeFrame: through study completion, up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Rice
role: PRINCIPAL_INVESTIGATOR
References: