Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Pancreatic Neoplasm and Duodenal Neoplasm, sponsored by Masonic Cancer Center, University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06411795 shows while recruiting
NCT06411795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 653-participant average among 10 other Pancreatic Neoplasm trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pancreatic Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06411795's enrollment target sits among peer trials
78 7th of 10 higher than 4 of 10 other Pancreatic Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
COMPLETED · Phase 2
-
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
COMPLETED · Phase 2
-
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
RECRUITING · Phase 3
-
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
RECRUITING · Early Phase 1
-
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
RECRUITING · Phase 1
-
Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02397668 · 78 participants · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
- NCT03321656 · 78 participants · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- NCT03687814 · 78 participants · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
- NCT04018872 · 78 participants · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI