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

NCT06411795 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: ANES-2023-31918NCI-2024-02287P30CA077598
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Milligram morphine equivalents (MME)

  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 Outcomes (5)

• Pain scores

  At 24, 48, 72 and 96 hours

• Hospital length of stay

  Up to 7 days after surgery

• Opioid consumption

  96 hours

• Time to return of bowel function

  Up to 7 days after surgery

• Incidence of nausea, vomiting, hypotension and pruritis

  At 24 hours, 48 hours, 72 hours and 96 hours

Study Arms (2)

Group E (TEA)

EXPERIMENTAL

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.

Drug: Bupivacaine; Drug: Hydromorphone; Drug: Iopamidol; Other: Medical Chart Review; Other: Questionnaire Administration; Drug: Thoracic Epidural Analgesia; Procedure: X-Ray Imaging

Group RS (rectus sheath block)

EXPERIMENTAL

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

Drug: Bupivacaine; Drug: Liposomal Bupivacaine; Other: Medical Chart Review; Other: Questionnaire Administration; Procedure: Ultrasound Imaging

Interventions

Bupivacaine DRUG

Given via epidural and injection

Also known as: AH 250

Group E (TEA); Group RS (rectus sheath block)

Hydromorphone DRUG

Given via epidural

Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Group E (TEA)

Iopamidol DRUG

Given via epidural

Also known as: Isovue, Niopam, Solutrast

Group E (TEA)

Liposomal Bupivacaine DRUG

Given injection

Also known as: Bupivacaine Liposome Injectable Suspension, Exparel

Group RS (rectus sheath block)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Group E (TEA); Group RS (rectus sheath block)

Questionnaire Administration OTHER

Ancillary studies

Group E (TEA); Group RS (rectus sheath block)

Thoracic Epidural Analgesia DRUG

Undergo thoracic epidural placement

Also known as: TEA, Thoracic Epidural

Group E (TEA)

Ultrasound Imaging PROCEDURE

Undergo ultrasound

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Group RS (rectus sheath block)

X-Ray Imaging PROCEDURE

Undergo x-ray

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray

Group E (TEA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Duodenal Neoplasms; Pancreatic Neoplasms

Interventions

Bupivacaine; Hydromorphone; Iopamidol; Tea; High-Energy Shock Waves; X-Rays; Phantoms, Imaging

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing; Equipment and Supplies

Study Officials

• James Flaherty

  University of Minnesota Masonic Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and providers will not be blinded to the analgesic technique
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: November 10, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (1)