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Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Start Date
November 10, 2023
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2028
Last Updated
February 3, 2026
78
ESTIMATED participants
Bupivacaine
DRUG
Hydromorphone
DRUG
Iopamidol
DRUG
Liposomal Bupivacaine
DRUG
Medical Chart Review
OTHER
Questionnaire Administration
OTHER
Thoracic Epidural Analgesia
DRUG
Ultrasound Imaging
PROCEDURE
X-Ray Imaging
PROCEDURE
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
NCT06051695
NCT06885697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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