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

February 2, 2026 updated by: Masonic Cancer Center, University of Minnesota

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
        • Principal Investigator:
          • James Flaherty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: X-Ray Imaging
Undergo x-ray
Other Names:
  • Conventional X-Ray
  • Diagnostic Radiology
  • Medical Imaging, X-Ray
  • Radiographic Imaging
  • Radiography
  • RG
  • Static X-Ray
  • X-Ray
  • Plain film radiographs
  • Radiographic imaging procedure (procedure)
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Drug: Bupivacaine
Given via epidural and injection
Other Names:
  • AH 250
Drug: Hydromorphone
Given via epidural
Other Names:
  • (-)-Hydromorphone
  • Dihydromorphinone
  • Hydromorphon
Drug: Iopamidol
Given via epidural
Other Names:
  • Isovue
  • Niopam
  • Solutrast
Drug: Thoracic Epidural Analgesia
Undergo thoracic epidural placement
Other Names:
  • TEA
  • Thoracic Epidural
Experimental: Group RS (rectus sheath block)
Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.
Other: Questionnaire Administration
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Procedure: Ultrasound Imaging
Undergo ultrasound
Other Names:
  • Ultrasound
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • Ultrasonography
Drug: Bupivacaine
Given via epidural and injection
Other Names:
  • AH 250
Drug: Liposomal Bupivacaine
Given injection
Other Names:
  • Exparel
  • Bupivacaine Liposome Injectable Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Milligram morphine equivalents (MME)
Time Frame: 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.
Up to 96 hours after open pancreatoduodenectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: At 24, 48, 72 and 96 hours
Pain scores at rest and with movement will be assessed using a numeric rating scale pain scores where 0 is no pain and 10 is worst pain.
At 24, 48, 72 and 96 hours
Hospital length of stay
Time Frame: Up to 7 days after surgery
Average hospital length of stay
Up to 7 days after surgery
Opioid consumption
Time Frame: 96 hours
Average Opioid consumption (milligrams)
96 hours
Time to return of bowel function
Time Frame: Up to 7 days after surgery
Average time to return of bowel function will be measured by first oral intake.
Up to 7 days after surgery
Incidence of nausea, vomiting, hypotension and pruritis
Time Frame: At 24 hours, 48 hours, 72 hours and 96 hours
At 24 hours, 48 hours, 72 hours and 96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: James Flaherty, University of Minnesota Masonic Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES-2023-31918 (Other Identifier: University of Minnesota/Masonic Cancer Center)
  • P30CA077598 (U.S. NIH Grant/Contract)
  • NCI-2024-02287 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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