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 range18 Years
SexALL
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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…