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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    96
  • sponsor
    M.D. Anderson Cancer Center
Updated on 14 August 2021
analgesia
cancer
hepatectomy
bowel resection
liver surgery

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.

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.

Details
Condition Liver Disease, liver diseases, hepatic pathology, LIVER DISEASE, hepatopathy, Liver and Intrahepatic Bile Duct Disorder, hepatic disease, hepatic diseases, Liver Disorders
Treatment Fentanyl, Questionnaires, Questionnaire, Hydromorphone, Liposomal bupivacaine, Bupivacaine, Hydromorphone Hydrochloride, Implanted Medical Device
Clinical Study IdentifierNCT03214510
SponsorM.D. Anderson Cancer Center
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

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
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