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

StatusRecruiting
PhasePhase 2
Started2023-11-10
View on ClinicalTrials.gov ↗

Amendment history

2026-02-02
minor
Study Status v2
Primary completion date2026-01-01→2027-01-01
Completion date2026-01-01→2028-01-01
2025-05-13
minor
Study Status v1
Re-verified, no change to tracked fields
2024-05-08
minor
Original filing
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.
Trial Details
NCT Number NCT06411795
Lead Sponsor Masonic Cancer Center, University of Minnesota
Collaborators: National Cancer Institute (NCI)
Conditions Duodenal Neoplasm, Pancreatic Neoplasm
Enrollment 78 participants
Start Date 2023-11-10
Primary Completion 2027-01-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-03