Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Indiana University

Status and phase: Terminated; Phase 3

Conditions: Thoracotomy; Pain, Postoperative

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05172570

10069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of substance abuse in the past 6 months which would include heroin, marijuana or 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 include gabapentin
• Patient unable to receive post-op epidural
• BMI above 40
• Creatinine clearance less than 30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

No Gabapentin

No Intervention group

Description:

Patients will not receive any gabapentin postoperatively after open thoracotomy

300 mg Gabapentin 3X per day

Active Comparator group

Description:

Patients will receive 300mg gabapentin 3x a day after open thoracotomy

Treatment:

Drug: Gabapentin

300 mg Gabapentin once per day at night

Active Comparator group

Description:

Patients will receive 300mg gabapentin once a day at night after open thoracotomy

Treatment:

Drug: Gabapentin