NCT03214510

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver and Intrahepatic Bile Duct Disorder

Interventions

Type	Name	Description
DRUG	Bupivacaine	Given via thoracic epidural catheter or TAP block
DRUG	Fentanyl	Given via thoracic epidural catheter
DRUG	Hydromorphone Hydrochloride	Given via thoracic epidural catheter
DEVICE	Implanted Medical Device	Undergo placement of thoracic epidural catheter
DEVICE	Implanted Medical Device	Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
DRUG	Liposomal Bupivacaine	Given via TAP block
BEHAVIORAL	Questionnaire	Ancillary studies

Timeline

• Start date: 2017-10-04
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2017-07-11
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study