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.
Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
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
Parallel
Bupivacaine
DrugGiven via epidural and injection
Hydromorphone
DrugGiven via epidural
Iopamidol
DrugGiven via epidural
Liposomal Bupivacaine
DrugGiven injection
Medical Chart Review
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Thoracic Epidural Analgesia
DrugUndergo thoracic epidural placement
Ultrasound Imaging
Procedure/SurgeryUndergo ultrasound
X-Ray Imaging
Procedure/SurgeryUndergo x-ray
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.
Pain scores
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.
Hospital length of stay
Average hospital length of stay
Opioid consumption
Average Opioid consumption (milligrams)
Time to return of bowel function
Average time to return of bowel function will be measured by first oral intake.
Click on the lead sponsor to view all of their trials.
Masonic Cancer Center, University of Minnesota
Lead sponsor
National Cancer Institute (NCI)
Collaborator
