Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy (NCT05172570) | Clinical Trial Compass
TerminatedPhase 3
Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Stopped: Study terminated to to shortage if study supplies for epidurals and most enrolled has study deviations due to not receiving correct post study drug assignments.
United States20 participantsStarted 2021-04-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Timeframe: 1 hour after surgery
2
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Timeframe: 24 hour after surgery
3
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Timeframe: 48 hour after surgery
4
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Timeframe: 72 hour after surgery
5
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.