Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Last updated: March 19, 2024
Sponsor: Indiana University
Overall Status: Terminated

Phase

3

Condition

Thoracotomy

Treatment

Gabapentin

Clinical Study ID

NCT05172570
10069
  • Ages 18-70
  • All Genders

Study Summary

Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Pt undergoing open thoracotomy at Indiana University Hospital
  • ASA 1,2,3 or 4
  • Age 18 or older, male or female

Exclusion

Exclusion criteria:

  • History of substance abuse in the past 6 months which would include heroin, marijuanaor any other illegal street drugs
  • Patient on home dose of gabapentin or pregabalin
  • Patient staying intubated after surgery
  • Patient above 70yo
  • Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
  • Known allergy or other contraindications to the study medications, which includegabapentin
  • Patient unable to receive post-op epidural
  • BMI above 40
  • Creatinine clearance less than 30

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Gabapentin
Phase: 3
Study Start date:
April 06, 2021
Estimated Completion Date:
March 02, 2022

Study Description

The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively.

Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications.

The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.

Connect with a study center

  • indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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