Clinical trial NCT05172570: Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Official title: Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Thoracotomy
Pain, Postoperative
Keywords: acute pain
neuropathic pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
timeFrame: 1 hour after surgery
measure: The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
timeFrame: 24 hour after surgery
measure: The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
timeFrame: 48 hour after surgery
measure: The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
timeFrame: 72 hour after surgery
measure: The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
timeFrame: 96 hour after surgery
Secondary outcomes:
measure: Opioid Usage
timeFrame: 1 hour after surgery.
measure: Opioid Usage
timeFrame: 24 hour after surgery.
measure: Opioid Usage
timeFrame: 48 hour after surgery.
measure: Opioid Usage
timeFrame: 72 hour after surgery.
measure: Opioid Usage
timeFrame: 96 hour after surgery.
measure: Time to First Opioid Request
timeFrame: As it first occurs, up to 96 hours after surgery
measure: Sedation Scores
timeFrame: 1hour after surgery.
measure: Sedation Scores
timeFrame: 24 hour after surgery.
measure: Sedation Scores
timeFrame: 48 hour after surgery.
measure: Sedation Scores
timeFrame: 72 hour after surgery.
measure: Sedation Scores
timeFrame: 96 hour after surgery.
measure: Incidence of Falls
timeFrame: As they occur up to 96 hours after surgery.
measure: Pulmonary Complications
timeFrame: As they occur up to 96 hours after surgery.
measure: Hospital Length of Stay
timeFrame: From the date of surgery to date of hospital discharge (up to 24 days)
measure: Delirium
timeFrame: 24 hours after surgery.
measure: Delirium
timeFrame: 48 hours after surgery.
measure: Delirium
timeFrame: 72 hours after surgery.
measure: Delirium
timeFrame: 96 hours after surgery.
measure: Visual Disturbance
timeFrame: 24 hours after surgery.
measure: Visual Disturbance
timeFrame: 48 hours after surgery.
measure: Visual Disturbance
timeFrame: 72 hours after surgery.
measure: Visual Disturbance
timeFrame: 96 hours after surgery.
measure: Dizziness
timeFrame: 24 hours after surgery.
measure: Dizziness
timeFrame: 48 hours after surgery.
measure: Dizziness
timeFrame: 72 hours after surgery.
measure: Dizziness
timeFrame: 96 hours after surgery.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
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