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Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Phase 3
Terminated
Conditions
Thoracotomy
Pain, Postoperative
Interventions
Registration Number
NCT05172570
Lead Sponsor
Indiana University
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
300 mg Gabapentin 3X per dayGabapentinPatients will receive 300mg gabapentin 3x a day after open thoracotomy
300 mg Gabapentin once per day at nightGabapentinPatients will receive 300mg gabapentin once a day at night after open thoracotomy
Primary Outcome Measures
NameTimeMethod
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.96 hour after surgery

The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.

Secondary Outcome Measures
NameTimeMethod
Pulmonary ComplicationsAs they occur up to 96 hours after surgery.

any incidence of increase oxygen requirements or respiratory depression will be recorded

Sedation Scores96 hour after surgery.

Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)

Opioid Usage96 hour after surgery.

opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.

Time to First Opioid RequestAs it first occurs, up to 96 hours after surgery

the timeframe between end of surgery to first opioid request

Delirium96 hours after surgery.

Number of Participants reported they experienced delirium.

Visual Disturbance96 hours after surgery.

incidence of any visual disturbance reported by the participants will be reported.

Incidence of FallsAs they occur up to 96 hours after surgery.

Participants with one or more falls

Dizziness96 hours after surgery.

incidence of any dizziness reported by the participant reported.

Hospital Length of StayFrom the date of surgery to date of hospital discharge (up to 24 days)

timeframe from start of surgery to time of discharge (up to 24 days)

Trial Locations

Locations (1)

indiana University

🇺🇸

Indianapolis, Indiana, United States

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