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NCT Number: NCT06411795

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

James Flaherty

CONTACT

[email protected]

314-322-3474

James Flaherty

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Given via epidural and injection

Other names: AH 250

Hydromorphone

Drug

Given via epidural

Other names: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon

Iopamidol

Drug

Given via epidural

Other names: Isovue, Niopam, Solutrast

Liposomal bupivacaine

Drug

Given injection

Other names: Bupivacaine Liposome Injectable Suspension, Exparel

medical chart review

Other

Ancillary studies

Other names: Chart Review

Questionnaire Administration

Other

Ancillary studies

Thoracic epidural analgesia

Drug

Undergo thoracic epidural placement

Other names: TEA, Thoracic Epidural

Ultrasound Imaging

Procedure

Undergo ultrasound

Other names: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

X-Ray Imaging

Procedure

Undergo x-ray

Other names: 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Hospital length of stay

    Time frame: Up to 7 days after surgery

    Average hospital length of stay

  3. Opioid consumption

    Time frame: 96 hours

    Average Opioid consumption (milligrams)

  4. 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.

  5. Incidence of nausea, vomiting, hypotension and pruritis

    Time frame: At 24 hours, 48 hours, 72 hours and 96 hours

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 13, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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