NCT06411795

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. Epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy.

Detailed description

PRIMARY OBJECTIVE: I. To determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia (TEA) for patients undergoing pancreatoduodenectomy. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP EPIDURAL (E): Prior to pancreatoduodenectomy, patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively. Patients also receive iopamidol via epidural and undergo x-ray imaging on study. GROUP RECTUS SHEATH (RS): Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.

Conditions

• Duodenal Neoplasm
• Pancreatic Neoplasm

Interventions

Type	Name	Description
DRUG	Bupivacaine	Given via epidural and injection
DRUG	Hydromorphone	Given via epidural
DRUG	Iopamidol	Given via epidural
DRUG	Liposomal Bupivacaine	Given injection
OTHER	Medical Chart Review	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Thoracic Epidural Analgesia	Undergo thoracic epidural placement
PROCEDURE	Ultrasound Imaging	Undergo ultrasound
PROCEDURE	X-Ray Imaging	Undergo x-ray

Timeline

• Start date: 2023-11-10
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-05-13
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study