NCT06411795RecruitingPhase 2
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 8 May 2024
- Start date
- 10 Nov 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Diseases
- Pancreatic cancer
- NCT number
- NCT06411795
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 78
- From 10 Nov 2023 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with chronic opioid use (at least 30 milligram morphine equivalents \[MME\] for 3 or more weeks leading up to surgery)
Other illness
- Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)
Other
- 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
Who the study is looking for
- Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.