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

Last updated: May 13, 2025
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Digestive System Neoplasms

Treatment

Questionnaire Administration

Ultrasound Imaging

Thoracic Epidural Analgesia

Clinical Study ID

NCT06411795
ANES-2023-31918
NCI-2024-02287
ANES-2023-31918
P30CA077598
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with contraindication to block placement (coagulopathy, local anestheticallergy, 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'sdiscretion

  • Patient refusal and those who have opted out of research

  • Pregnant patients - will be assessed through review of the medical record

Study Design

Total Participants: 78
Treatment Group(s): 9
Primary Treatment: Questionnaire Administration
Phase: 2
Study Start date:
November 10, 2023
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

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