Pain Control After Pancreatic Surgery: Rectus Sheath Block vs. Epidural

This study is comparing two ways to manage pain after a surgery called pancreatoduodenectomy (removal of part of the pancreas and duodenum) for duodenal or pancreatic cancer. One method uses a rectus sheath block, where Liposomal Bupivacaine is injected into the abdominal muscles to help with pain. The other method is a thoracic epidural analgesia (TEA), which involves placing a small tube in your back to deliver pain medications like Bupivacaine and Hydromorphone. The main goal is to see if the rectus sheath block provides similar pain relief to the epidural. You might be able to join if you are an adult (18 or older) having this surgery at the University of Minnesota. The study is currently unclear on its recruitment status and plans to enroll 78 participants.

Study design
This is an interventional study where 78 adult participants will be randomly assigned to one of two groups to receive either a rectus sheath block or a thoracic epidural.
What's involved
If you are in the epidural group, you will have an epidural placed and receive continuous medication for up to 72 hours after surgery, plus an x-ray. If you are in the rectus sheath group, you will receive an ultrasound-guided injection before surgery.
Compensation
Not stated in the trial record.
Follow-up
Pain relief will be measured for up to 96 hours after surgery.

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NCT06411795

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Masonic Cancer Center, University of Minnesota
~78 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:BupivacaineHydromorphoneIopamidolLiposomal BupivacaineMedical Chart ReviewQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Milligram morphine equivalents (MME)
Measured over Up to 96 hours after open pancreatoduodenectomy
Duodenal Neoplasm
Pancreatic Neoplasm
1 sites across 1 states
Minnesota1
  • James Flaherty · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, University of Minnesota

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Eligibility criteria

Inclusion

Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study

Exclusion

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
  • Milligram morphine equivalents (MME)Up to 96 hours after open pancreatoduodenectomy

    Opioid consumption will be evaluated as a non-inferiority hypothesis using a two-sample t-test to compare the groups, with the conclusion of statistical significance being drawn from the corresponding confidence interval for the differences in mean MMEs between groups.