- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2023-11-10
2026-01-01
2026-01-01
78
NCT06411795
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
INTERVENTIONAL
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.
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.
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 | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-05-08 | N/A | 2025-05-13 |
2024-05-08 | N/A | 2025-05-14 |
2024-05-13 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group E (TEA) 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 imag | DRUG: Bupivacaine
DRUG: Hydromorphone
DRUG: Iopamidol
OTHER: Medical Chart Review
OTHER: Questionnaire Administration
DRUG: Thoracic Epidural Analgesia
PROCEDURE: X-Ray Imaging
|
| EXPERIMENTAL: Group RS (rectus sheath block) 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | At 24, 48, 72 and 96 hours |
| Hospital length of stay | Average hospital length of stay | Up to 7 days after surgery |
| Opioid consumption | Average Opioid consumption (milligrams) | 96 hours |
| Time to return of bowel function | Average time to return of bowel function will be measured by first oral intake. | Up to 7 days after surgery |
| Incidence of nausea, vomiting, hypotension and pruritis | At 24 hours, 48 hours, 72 hours and 96 hours |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
