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

Last updated: March 3, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

3

Condition

Primary Biliary Cholangitis

Treatment

Hydromorphone Hydrochloride

Bupivacaine

Implanted Medical Device

Clinical Study ID

NCT03214510
2016-1111
2016-1111
NCI-2018-01124
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing open liver resection without bowel resection/anastomosis formalignancy 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 medicalcondition that would preclude epidural placement

Exclusion

Exclusion Criteria:

  • Evidence of severe uncontrolled systemic disease or other comorbidity that precludesliver surgery

  • History of chronic narcotic use, defined as 30 days or more of preoperative dailynarcotic 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 generalanesthesia

  • Technical contraindications to epidural placement: previous thoracic spinal surgeryor local skin or soft tissue infection at proposed site for epidural insertion

  • Use of therapeutic anticoagulation within 5 days of surgery (not including venousthromboembolism prophylaxis)

  • Known bleeding diathesis or coagulopathy

  • Psychiatric (untreated or poorly controlled schizophrenia, major depression, orbipolar disorder), or communication (language) barrier that would preclude accurateassessment of postoperative pain and/or ability to answer questionnaires (need to beable 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 ahysterectomy or who have not been postmenopausal for at least 12 consecutive months)must agree to practice adequate contraception and to refrain from breast-feeding, asspecified in the informed consent

  • Patients with obvious unresectable disease prior to signing informed consent

  • Patients with previous ventral hernia repair, cosmetic abdominoplasty or anteriorabdominal wall reconstruction

Study Design

Total Participants: 96
Treatment Group(s): 6
Primary Treatment: Hydromorphone Hydrochloride
Phase: 3
Study Start date:
October 04, 2017
Estimated Completion Date:
July 31, 2026

Study Description

PRIMARY OBJECTIVE:

I. To compare length of hospital stay between patients treated with thoracic epidural analgesia (TEA) versus (vs.) pre-incision ultrasound-guided, four-quadrant transversus abdominus plane (TAP) block after open liver resection within an enhanced recovery program.

SECONDARY OBJECTIVES:

I. To compare the area under the curve of early (0-48 hour) post-operative pain scores and number of patients who experience severe postoperative pain between the TEA and TAP groups.

II. To compare anesthetic-related complication rates and need to change modalities between TEA and TAP groups.

III. To compare surgery-related complications (including 30-day readmission and 90-day mortality rates) between TEA and TAP groups.

IV. To compare return to baseline symptom burden, functional and cognitive status between TEA and TAP groups.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo placement of thoracic epidural catheter before surgery. Patients receive hydromorphone hydrochloride and bupivacaine via thoracic epidural catheter every 10 minutes or 3 hours as needed. Patients may receive fentanyl and bupivacaine or plain bupivacaine via thoracic epidural catheter.

ARM II: Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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