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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT06411795
Phase
PHASE2
Status
Recruiting
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Conditions

  • Duodenal Neoplasm
  • Pancreatic Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine — DRUG
    Given via epidural and injection
  • Hydromorphone — DRUG
    Given via epidural
  • Iopamidol — DRUG
    Given via epidural
  • Liposomal Bupivacaine — DRUG
    Given injection
  • Medical Chart Review — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Thoracic Epidural Analgesia — DRUG
    Undergo thoracic epidural placement
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455
James Flaherty
[email protected]
314-322-3474
James Flaherty (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota/Masonic Cancer Center· Minneapolis, MN

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