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.
Additional locations may be listed on ClinicalTrials.gov for NCT03214510.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Timothy Eric Newhook
Phone: 713-792-6940
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. Patients undergo blood sample collection throughout the study.
ARM II: Patients undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block. Patients receive plain bupivacaine and liposomal bupivacaine via TAP block. Patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at week 2-8 and month 3, 4, 5 and 6.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorTimothy Eric Newhook