Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
NCT ID: NCT03214510
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
96 participants
INTERVENTIONAL
2017-10-04
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (TAE)
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.
Bupivacaine
Given via thoracic epidural catheter or TAP block
Fentanyl
Given via thoracic epidural catheter
Hydromorphone Hydrochloride
Given via thoracic epidural catheter
Implanted Medical Device
Undergo placement of thoracic epidural catheter
Questionnaire
Ancillary studies
Arm II (TAP)
Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block.
Bupivacaine
Given via thoracic epidural catheter or TAP block
Implanted Medical Device
Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
Liposomal Bupivacaine
Given via TAP block
Questionnaire
Ancillary studies
Interventions
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Bupivacaine
Given via thoracic epidural catheter or TAP block
Fentanyl
Given via thoracic epidural catheter
Hydromorphone Hydrochloride
Given via thoracic epidural catheter
Implanted Medical Device
Undergo placement of thoracic epidural catheter
Implanted Medical Device
Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
Liposomal Bupivacaine
Given via TAP block
Questionnaire
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Timothy E. Newhook, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-01124
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-1111
Identifier Type: OTHER
Identifier Source: secondary_id
2016-1111
Identifier Type: -
Identifier Source: org_study_id
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