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Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
NCT06411795 · Masonic Cancer Center, University of Minnesota
In plain English
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Official title
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
About this study
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.
Eligibility 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
Study design
Enrollment target: 78 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-11-10
Estimated completion: 2028-01-01
Last updated: 2026-02-03
Interventions
Drug: BupivacaineDrug: HydromorphoneDrug: IopamidolDrug: Liposomal BupivacaineOther: Medical Chart ReviewOther: Questionnaire AdministrationDrug: Thoracic Epidural AnalgesiaProcedure: Ultrasound ImagingProcedure: X-Ray Imaging
Primary outcomes
- • Milligram morphine equivalents (MME) (Up to 96 hours after open pancreatoduodenectomy)
Sponsor
Masonic Cancer Center, University of Minnesota · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorJames Flaherty · principal_investigator, University of Minnesota Masonic Cancer Center
All locations (1)
University of Minnesota/Masonic Cancer CenterRecruiting
Minneapolis, Minnesota, United States