Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

March 19, 2024 updated by: Yar Yeap, Indiana University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Gabapentin
Patients will not receive any gabapentin postoperatively after open thoracotomy
Active Comparator: 300 mg Gabapentin 3X per day
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Drug: Gabapentin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Other Names:
  • neurontin
Active Comparator: 300 mg Gabapentin once per day at night
Patients will receive 300mg gabapentin once a day at night after open thoracotomy
Drug: Gabapentin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Other Names:
  • neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time Frame: 1 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.
1 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time Frame: 24 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.
24 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time Frame: 48 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.
48 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time Frame: 72 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.
72 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time Frame: 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.
96 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Usage
Time Frame: 1 hour after surgery.
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
1 hour after surgery.
Opioid Usage
Time Frame: 24 hour after surgery.
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
24 hour after surgery.
Opioid Usage
Time Frame: 48 hour after surgery.
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
48 hour after surgery.
Opioid Usage
Time Frame: 72 hour after surgery.
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
72 hour after surgery.
Opioid Usage
Time Frame: 96 hour after surgery.
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
96 hour after surgery.
Sedation Scores
Time Frame: 1hour 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)
1hour after surgery.
Sedation Scores
Time Frame: 24 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)
24 hour after surgery.
Sedation Scores
Time Frame: 48 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)
48 hour after surgery.
Sedation Scores
Time Frame: 72 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)
72 hour after surgery.
Sedation Scores
Time Frame: 96 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)
96 hour after surgery.
Delirium
Time Frame: 48 hours after surgery.
incidence of delirium will be recorded
48 hours after surgery.
Time to First Opioid Request
Time Frame: As it first occurs, up to 96 hours after surgery
the timeframe between end of surgery to first opioid request
As it first occurs, up to 96 hours after surgery
Incidence of Falls
Time Frame: As they occur up to 96 hours after surgery.
Participants with one or more falls
As they occur up to 96 hours after surgery.
Pulmonary Complications
Time Frame: As they occur up to 96 hours after surgery.
any incidence of increase oxygen requirements or respiratory depression will be recorded
As they occur up to 96 hours after surgery.
Hospital Length of Stay
Time Frame: From 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)
From the date of surgery to date of hospital discharge (up to 24 days)
Delirium
Time Frame: 24 hours after surgery.
Number of Participants reported they experienced delirium.
24 hours after surgery.
Delirium
Time Frame: 72 hours after surgery.
Number of Participants reported they experienced delirium.
72 hours after surgery.
Delirium
Time Frame: 96 hours after surgery.
Number of Participants reported they experienced delirium.
96 hours after surgery.
Visual Disturbance
Time Frame: 24 hours after surgery.
incidence of any visual disturbance reported by the participants will be reported.
24 hours after surgery.
Visual Disturbance
Time Frame: 48 hours after surgery.
incidence of any visual disturbance reported by the participants will be reported.
48 hours after surgery.
Visual Disturbance
Time Frame: 72 hours after surgery.
incidence of any visual disturbance reported by the participants will be reported.
72 hours after surgery.
Visual Disturbance
Time Frame: 96 hours after surgery.
incidence of any visual disturbance reported by the participants will be reported.
96 hours after surgery.
Dizziness
Time Frame: 24 hours after surgery.
incidence of any dizziness reported by the participant reported.
24 hours after surgery.
Dizziness
Time Frame: 48 hours after surgery.
iincidence of any dizziness reported by the participant reported.
48 hours after surgery.
Dizziness
Time Frame: 72 hours after surgery.
incidence of any dizziness reported by the participant reported.
72 hours after surgery.
Dizziness
Time Frame: 96 hours after surgery.
incidence of any dizziness reported by the participant reported.
96 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Yar Yeap, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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