Clinical trial

Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

ID

Name

10069

Description

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.

Trial arms

Trial start

2021-04-06

Estimated PCD

2022-02-25

Trial end

2022-03-02

Status

Terminated

Phase

Early phase I

Treatment

Gabapentin

Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.

Arms:

300 mg Gabapentin 3X per day, 300 mg Gabapentin once per day at night

Other names:

neurontin

Size

20

Primary endpoint

The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

1 hour after surgery

The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

24 hour after surgery

The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

48 hour after surgery

The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

72 hour after surgery

The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.

96 hour after surgery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2024-03-21

1 organization

1 product

3 indications

Organization

Indiana University

Product

Indication

Indication

Indication