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Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
October 4, 2017
Primary Completion Date
July 31, 2026
Completion Date
July 31, 2026
Last Updated
March 5, 2026
101
ACTUAL participants
Bupivacaine
DRUG
Fentanyl
DRUG
Hydromorphone Hydrochloride
DRUG
Implanted Medical Device
DEVICE
Implanted Medical Device
DEVICE
Liposomal Bupivacaine
DRUG
Questionnaire
BEHAVIORAL
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
Data Source & Attribution
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