Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bupivacaine; Fentanyl; Hydromorphone

Criteria

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