Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain i… (NCT03214510) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
United States101 participantsStarted 2017-10-04
Plain-language summary
This phase III trial studies how well thoracic epidural analgesia or four-quadrant transversus abdominus plane block works in reducing pain in patients undergoing liver surgery. It is not yet known whether thoracic epidural analgesia or four-quadrant transversus abdominus plane block may help people to recover more completely and more quickly after surgery.
Who can participate
Age range
18 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:
* Patients undergoing open liver resection without bowel resection/anastomosis for malignancy at MD Anderson Cancer Center
* Patients must sign a study-specific consent form
* Platelets \>= 100,000/ml (within 30 days of surgery)
* International normalized ratio (INR) =\< 1.5 (within 30 days of surgery)
* Activated partial thromboplastin time (aPTT) =\< 40 (within 30 days of surgery)
* Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement
Exclusion Criteria:
* Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
* History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
* Anaphylaxis to local anesthetics or narcotics
* Previous or current neurologic disease affecting the lower hemithorax or below
* Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
* Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion
* Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
* Known bleeding diathesis or coagulopathy
* Psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate a…
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.