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

Trial ID: NCT06411795

Interventional - Phase 2 - Recruiting

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

Interventions

• Bupivacaine
• Hydromorphone
• Iopamidol
• Liposomal Bupivacaine
• Medical Chart Review
• Questionnaire Administration
• Thoracic Epidural Analgesia
• Ultrasound Imaging
• X-Ray Imaging

Eligibility

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

Sponsor

Masonic Cancer Center, University of Minnesota, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows