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Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
RECRUITINGPhase 3Sponsored by M.D. Anderson Cancer Center
Actively Recruiting
PhasePhase 3
SponsorM.D. Anderson Cancer Center
Started2017-10-04
Est. completion2026-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03214510
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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 assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions) * Inability to comply with study and/or follow-up procedures * Patient refusal to participate in randomization * Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent * Patients with obvious unresectable disease prior to signing informed consent * Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction
Conditions2
Liver DiseaseLiver and Intrahepatic Bile Duct Disorder
Locations1 site
M D Anderson Cancer Center
Houston, Texas, 77030
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Actively Recruiting
PhasePhase 3
SponsorM.D. Anderson Cancer Center
Started2017-10-04
Est. completion2026-07-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03214510