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Search / Trial NCT03214510

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

Launched by M.D. ANDERSON CANCER CENTER · Jul 10, 2017

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for managing pain in patients who are undergoing liver surgery: thoracic epidural analgesia and a technique called four-quadrant transversus abdominus plane block. The goal is to find out which method helps reduce pain more effectively and supports better recovery after surgery. Currently, the trial is recruiting participants aged 65 to 74 who will have open liver surgery at MD Anderson Cancer Center and meet specific health criteria.

To participate, patients must be eligible based on their health status, including having a certain level of blood platelets and no active infections. Patients will be asked to sign a consent form before joining the study. Those who take part can expect to receive one of the two pain management techniques and will be monitored for their recovery and pain levels after surgery. It’s important to note that some individuals, such as those with certain medical conditions or recent surgeries, may not be eligible to join. Overall, this trial aims to help improve pain management for liver surgery patients, enhancing their overall recovery experience.

Gender

ALL

Eligibility 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

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Timothy E. Newhook, MD

Principal Investigator

M.D. Anderson Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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