RECRUITING

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

Conditions

Liver and Intrahepatic Bile Duct Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-10-04

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03214510

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Timothy E. Newhook, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-04

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2017-10-04

Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

Liver and Intrahepatic Bile Duct Disorder