A Phase 2 interventional study of Bupivacaine and Hydromorphone in Duodenal Neoplasm and Pancreatic Neoplasm, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Supportive care
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Among 13 studies in Duodenal Neoplasms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Duodenal Neoplasms · United States.
Among the 13 studies in Duodenal Neoplasms with a site in United States, this one is one of 2 that started in 2023, is one of 4 in phase 2, and was the 10th registered.
51 studies on the registry are indexed under Duodenal Neoplasms; 14 are open to participants now.
Browse Duodenal Neoplasms studies →4 of the 13 studies in Duodenal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
AdventHealth · Sites in United States
Ages 18–80
University of Nebraska · Sites in United States
Ages 19–110 · Healthy volunteers
University of Illinois at Chicago · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Duodenal Neoplasms studies recruiting now, 6 (55%) set no upper age limit and 1 (9%) stops at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 78 is below the median of 100 across 31 interventional studies indexed under Duodenal Neoplasms.
Median enrollment 50 across the 9 interventional studies, 6,100 across the 4 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
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None of the 13 has an industry lead sponsor. The 10 most frequent:
Masonic Cancer Center, University of Minnesota is the lead sponsor of 286 studies on the registry; 35 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Masonic Cancer Center, University of Minnesota has 1 study filed under Duodenal Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies in Duodenal Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06411795Masonic Cancer Center, University of MinnesotaRectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy | 2027-01-01 |
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Among the 13 studies in Duodenal Neoplasms with a site in United States, from their registry updates:
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivacaine · Drug: Hydromorphone · Drug: Iopamidol · Other: Medical Chart Review · Other: Questionnaire Administration · Drug: Thoracic Epidural Analgesia · Procedure: X-Ray Imaging
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
Given via epidural and injection
Also known as: AH 250
Given via epidural
Also known as: (-)-Hydromorphone, Dihydromorphinone, Hydromorphon
Given via epidural
Also known as: Isovue, Niopam, Solutrast
Given injection
Also known as: Bupivacaine Liposome Injectable Suspension, Exparel
Ancillary studies
Also known as: Chart Review
Ancillary studies
Undergo thoracic epidural placement
Also known as: TEA, Thoracic Epidural
Undergo ultrasound
Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US
Undergo x-ray
Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray
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.
Time frame: Up to 96 hours after open pancreatoduodenectomy
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.
Time frame: At 24, 48, 72 and 96 hours
Hospital length of stay
Average hospital length of stay
Time frame: Up to 7 days after surgery
Opioid consumption
Average Opioid consumption (milligrams)
Time frame: 96 hours
Time to return of bowel function
Average time to return of bowel function will be measured by first oral intake.
Time frame: Up to 7 days after surgery
Incidence of nausea, vomiting, hypotension and pruritis
Time frame: At 24 hours, 48 hours, 72 hours and 96 hours
Started Nov 2023 (actual). Primary completion is estimated for Jan 2027, 37 months after the start.
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Studies of the drug tested here: Liposomal Bupivacaine
Masonic Cancer Center, University of Minnesota →