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

Description

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.

Conditions

Liver and Intrahepatic Bile Duct Disorder

Study Overview

Study Details

Study overview

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.

Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery

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

Condition
Liver and Intrahepatic Bile Duct Disorder
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Timothy E. Newhook, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2026-07-31