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Recruiting NCT06411795

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

Phase II Interventional Duodenal Neoplasm Pancreatic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine, Hydromorphone, Iopamidol, Liposomal Bupivacaine.
Who it may be relevant to
Registry conditions: Duodenal Neoplasm, Pancreatic Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Milligram morphine equivalents (MME) [Time frame: Up to 96 hours after open pancreatoduodenectomy]
Secondary outcome measures (5)
  • Pain scores [Time frame: At 24, 48, 72 and 96 hours]
  • Hospital length of stay [Time frame: Up to 7 days after surgery]
  • Opioid consumption [Time frame: 96 hours]
  • Time to return of bowel function [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Minnesota/Masonic Cancer Center — Minneapolis

Identifiers

NCT: NCT06411795 · ANES-2023-31918 · NCI-2024-02287 · ANES-2023-31918 · P30CA077598

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗