Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy (NCT06411795)
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (6 items).
Location: University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)
- Patients with chronic opioid use (at least 30 milligram morphine equivalents \[MME\] for 3 or more weeks leading up to surgery)
- Patients unable to understand the quality of recovery survey intellectual barriers. This will be determined by the primary investigator/attending anesthesiologist's discretion
- Patient refusal and those who have opted out of research
- Pregnant patients - will be assessed through review of the medical record
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
📞 Contact the Study Coordinator
Phone: (314) 322-3474
Email: jflahert@umn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.