Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2017-10-04
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 96
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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