NCT06411795 Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
| NCT ID | NCT06411795 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Duodenal Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2023-11-10 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
James Flaherty
PRINCIPAL INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Frequently Asked Questions
Who can join the NCT06411795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Duodenal Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06411795 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06411795 currently recruiting?
Yes, NCT06411795 is actively recruiting participants. Visit ClinicalTrials.gov or contact Masonic Cancer Center, University of Minnesota to inquire about joining.
Where is the NCT06411795 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06411795 clinical trial?
NCT06411795 is sponsored by Masonic Cancer Center, University of Minnesota. The principal investigator is James Flaherty at Masonic Cancer Center, University of Minnesota. The trial plans to enroll 78 participants.