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Local Anesthetic

Pain Control Methods for Pancreatic Cancer Surgery

Phase 2
Recruiting
Led By James Flaherty
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24, 48, 72 and 96 hours
Awards & highlights

Summary

"This trial compares the use of two pain control methods after pancreas and duodenectomy surgery. One method involves injecting a long-acting local anesthetic between muscle layers in the abdomen (rectus she

Who is the study for?
This trial is for patients undergoing pancreatoduodenectomy, a surgery for pancreatic and duodenal tumors. Participants must be eligible for the surgical procedure and fit enough to receive either of the pain control methods being tested.
What is being tested?
The study compares rectus sheath block with liposomal bupivacaine—a long-acting local anesthetic—against thoracic epidural analgesia (TEA), which delivers pain medication directly near the spine. The goal is to determine which method offers better post-surgery pain relief without causing low blood pressure.
What are the potential side effects?
Possible side effects include discomfort at injection sites, risk of infection, potential allergic reactions to anesthetics used, and low blood pressure particularly associated with TEA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and will have a specific pancreatic surgery at the University of Minnesota.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have block placement due to bleeding disorders, allergy to local anesthetics, or infection.
Select...
I have been using opioids equivalent to 30mg of morphine daily for over 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24, 48, 72 and 96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24, 48, 72 and 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Milligram morphine equivalents (MME)
Secondary outcome measures
Hospital length of stay
Opioid consumption
Pain scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group RS (rectus sheath block)Experimental Treatment5 Interventions
Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath.
Group II: Group E (TEA)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Hydromorphone
2005
Completed Phase 4
~4340
Iopamidol
2017
Completed Phase 4
~1160
Liposomal Bupivacaine
2016
Completed Phase 4
~1540
Ultrasound Imaging
2018
Completed Phase 4
~750

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
278 Previous Clinical Trials
15,513 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,811 Total Patients Enrolled
James FlahertyPrincipal InvestigatorUniversity of Minnesota Masonic Cancer Center
~47 spots leftby Jan 2026
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