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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 3

Conditions: Liver and Intrahepatic Bile Duct Disorder

Treatments: Drug: Hydromorphone Hydrochloride; Drug: Fentanyl; Device: Implanted Medical Device; Behavioral: Questionnaire; Drug: Liposomal Bupivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03214510

2016-1111 (Other Identifier)

NCI-2018-01124 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Arm I (TAE)

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Behavioral: Questionnaire

Device: Implanted Medical Device

Device: Implanted Medical Device

Drug: Hydromorphone Hydrochloride

Drug: Fentanyl

Arm II (TAP)

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Liposomal Bupivacaine

Behavioral: Questionnaire

Device: Implanted Medical Device

Device: Implanted Medical Device