Comparing two pain relief methods after pancreas surgery
Official title: Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
Run by Masonic Cancer Center, University of Minnesota · NCT06411795 · Data updated 2026-11-12
This study is testing whether a new way of giving pain relief after pancreas surgery works just as well as the traditional method, to help patients feel better with fewer risks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | November 10, 2023 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT06411795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients aged 18 and older scheduled for open pancreaticoduodenectomy at the University of Minnesota.
✕Probably not a fit
Patients with contraindications to block placement, chronic opioid use, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of rectus sheath block with liposomal bupivacaine versus thoracic epidural analgesia (TEA) for pain management in patients undergoing pancreatoduodenectomy. Patients are randomly assigned to receive either a continuous infusion of anesthetics through an epidural catheter or an injection of long-acting local anesthetic into the abdominal muscle layers. The goal is to determine if the rectus sheath block provides comparable pain relief to TEA while potentially reducing the risk of complications associated with epidurals. The study aims to improve postoperative pain control for patients undergoing this complex surgical procedure.
Why it matters
Potential benefit: If successful, this study could provide a safer and effective pain management option for patients after pancreatoduodenectomy.
How similar studies have gone: Previous studies have shown that epidurals are effective for postoperative pain control, but the use of rectus sheath blocks with liposomal bupivacaine is a relatively novel approach that requires further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study 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
Where it's running
-
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: James Flaherty — Masonic Cancer Center, University of Minnesota
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.