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Gabapentin for Postoperative Pain After Thoracotomy
Phase 3
Waitlist Available
Led By Yar Yeap, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older, male or female
Pt undergoing open thoracotomy at Indiana University Hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hour after surgery.
Awards & highlights
Study Summary
This trial is testing whether a nerve medication can help with post-operative pain and decrease the amount of opioids needed.
Who is the study for?
This trial is for adults aged 18 or older who are undergoing open thoracotomy at Indiana University Hospital. They should be in a stable physical state (ASA 1-4) and not have a history of substance abuse within the last six months, nor take gabapentin, pregabalin, or more than 30mg daily morphine equivalent. Those with allergies to study medications, BMI over 40, poor kidney function (creatinine clearance <30), or remaining intubated post-surgery cannot join.Check my eligibility
What is being tested?
The trial tests if different dosages of Gabapentin reduce pain after thoracotomy surgery. Participants will receive no gabapentin, a dose of 300 mg three times daily, or just one dose of 300 mg at night. The goal is to see if higher doses lead to less pain at incision sites and lower opioid use.See study design
What are the potential side effects?
Gabapentin may cause side effects such as dizziness, fatigue, coordination problems, swelling in limbs (edema), blurred vision and gastrointestinal issues like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for an open chest surgery at Indiana University Hospital.
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My health status is classified between low to high risk for surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ as it first occurs, up to 96 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~as it first occurs, up to 96 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Secondary outcome measures
Delirium
Dizziness
Hospital Length of Stay
+6 moreTrial Design
3Treatment groups
Active Control
Group I: 300 mg Gabapentin once per day at nightActive Control1 Intervention
Patients will receive 300mg gabapentin once a day at night after open thoracotomy
Group II: No GabapentinActive Control1 Intervention
Patients will not receive any gabapentin postoperatively after open thoracotomy
Group III: 300 mg Gabapentin 3X per dayActive Control1 Intervention
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,283 Total Patients Enrolled
Yar Yeap, MDPrincipal InvestigatorIndiana University
6 Previous Clinical Trials
670 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take more than 30mg of pain medication daily.I remained on a breathing machine after surgery.You have used illegal drugs like heroin or marijuana in the last 6 months.I am over 70 years old.I am 18 years old or older.I am scheduled for an open chest surgery at Indiana University Hospital.I am currently taking gabapentin or pregabalin.My health status is classified between low to high risk for surgery.My BMI is over 40.I am not allergic to gabapentin or other study medications.I cannot have an epidural after surgery.Your kidneys are not working well enough to clear waste from your body.
Research Study Groups:
This trial has the following groups:- Group 1: 300 mg Gabapentin once per day at night
- Group 2: No Gabapentin
- Group 3: 300 mg Gabapentin 3X per day
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it dangerous to take 900 mg of Gabapentin every 9 hours?
"3."
Answered by AI
Who meets the requirements to take part in this experiment?
"This study is recruiting patients that have undergone thoracotomy and are aged between 18-70. They require approximately 120 people for the trial."
Answered by AI
Is this dosage of Gabapentin common in other research?
"There are currently 28 active clinical trials for 300 mg Gabapentin 3X per day, with 11 of them being in Phase 3. Most of the studies for this dosage are located in Columbus, Ohio, but there are 71 total locations running trials across the United States."
Answered by AI
Are geriatric patients being included in this clinical research?
"For this specific clinical trial, only patients aged 18 to 70 can enroll. In contrast, there are 82 trials for minors and 433 trials for adults over the age of 65."
Answered by AI
What does Gabapentin 300 mg 3X per day help to ameliorate?
"300mg of gabapentin taken 3 times daily can help to alleviate the pain caused by neuralgia, epilepsies, and postherpetic neuralgia."
Answered by AI
Are recruitment efforts for this research underway?
"That is correct. The clinical trial, which was first posted on April 6th 2021 and last updated December 10th 2021 according to clinicaltrials.gov, is still recruiting patients. They are looking for 120 people total from 1 site."
Answered by AI
How many people are eligible for this research project?
"That is correct, the clinical trial mentioned is still looking for patients to enroll. The posting date was April 6th 2021 with the latest update on December 10th of the same year. They are hoping to have 120 people sign up at 1 location."
Answered by AI
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