RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-10
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06411795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
  1. * Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)
  2. * Patients with chronic opioid use (at least 30 milligram morphine equivalents \[MME\] for 3 or more weeks leading up to surgery)
  3. * Patients unable to understand the quality of recovery survey intellectual barriers. This will be determined by the primary investigator/attending anesthesiologist's discretion
  4. * Patient refusal and those who have opted out of research
  5. * Pregnant patients - will be assessed through review of the medical record

Contacts and Locations

Principal Investigator

James Flaherty
PRINCIPAL_INVESTIGATOR
University of Minnesota Masonic Cancer Center

Study Locations (Sites)

University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

  • James Flaherty, PRINCIPAL_INVESTIGATOR, University of Minnesota Masonic Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-10
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2023-11-10
Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Duodenal Neoplasm
  • Pancreatic Neoplasm