Recruiting
Phase 2

Liposomal Bupivacaine vs. Thoracic Epidural

Sponsor:

Masonic Cancer Center, University of Minnesota

Code:

NCT06411795

Conditions

Duodenal Neoplasm

Pancreatic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Hydromorphone

Iopamidol

Liposomal Bupivacaine

Medical Chart Review

Study Details

Brief summary:

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.

Conditions

Duodenal Neoplasm

Pancreatic Neoplasm

Study ID

NCT06411795

Start date

Nov 10, 2023

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group E (TEA)

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.

experimental: Group RS (rectus sheath block)

Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.

Interventions

Bupivacaine

Given via epidural and injection

Hydromorphone

Given via epidural

Iopamidol

Given via epidural

Liposomal Bupivacaine

Given injection

Medical Chart Review

Ancillary studies

Questionnaire Administration

Ancillary studies

Thoracic Epidural Analgesia

Undergo thoracic epidural placement

Ultrasound Imaging

Undergo ultrasound

X-Ray Imaging

Undergo x-ray

Primary outcome measure

  • Milligram morphine equivalents (MME) [ Time Frame: Up to 96 hours after open pancreatoduodenectomy ]

Central Contacts and Locations

Locations

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

James Flaherty

314-322-3474jflahert@umn.edu

Principal Investigator:

James Flaherty

More Information

Sponsor

Masonic Cancer Center, University of Minnesota

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota on 2026-02-03.