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NCT06411795 · ClinicalTrials.gov registry record · Phase 2
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
A Phase 2 study of Pancreatic Neoplasm and Duodenal Neoplasm, sponsored by Masonic Cancer Center, University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT06411795 is a Phase 2 study of Pancreatic Neoplasm and Duodenal Neoplasm that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 78 participants, below the 653-participant average among 10 other Pancreatic Neoplasm trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06411795, a Phase 2 study of Pancreatic Neoplasm and Duodenal Neoplasm, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Bupivacaine
- OTHER Medical Chart Review
- DRUG Liposomal Bupivacaine
- DRUG Hydromorphone
- DRUG Iopamidol
Study Locations (1)
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2023-11-10 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06411795
The ClinicalTrials.gov registry entry for NCT06411795 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 653-participant average among 10 other Pancreatic Neoplasm trials with a reported enrollment target (88% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pancreatic Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Bupivacaine is the first listed.
NCT06411795 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06411795 about?
NCT06411795 is a clinical study titled "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, ...
What is the current status of trial NCT06411795?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2023-11-10. Estimated completion is 2028-01-01.
What conditions does trial NCT06411795 study?
This clinical trial studies the following conditions: Pancreatic Neoplasm, Duodenal Neoplasm.
What interventions are being tested in trial NCT06411795?
The interventions under investigation include: Bupivacaine (DRUG), Medical Chart Review (OTHER), Liposomal Bupivacaine (DRUG), Hydromorphone (DRUG), Iopamidol (DRUG).
Who is sponsoring clinical trial NCT06411795?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06411795 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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