Duodenal NeoplasmPhase 2NCT06411795
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
A Phase 2 study testing Bupivacaine, Hydromorphone and Iopamidol in people with Duodenal Neoplasm and Pancreatic Neoplasm, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Neoplasm, Pancreatic Neoplasm
- What is being tested?
- Bupivacaine, Hydromorphone and Iopamidol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
Who cannot join
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
James Flaherty, 314-322-3474, jflahert@umn.edu
James Flaherty
About this study
Official title: Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Duodenal Neoplasm, Pancreatic Neoplasm
- Being tested
- Bupivacaine, Hydromorphone, Iopamidol, Liposomal Bupivacaine, Medical Chart Review
- Medical subject headings
- Duodenal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called AH 250
Given via epidural and injection
HydromorphoneDrug
Also called (-)-Hydromorphone, Dihydromorphinone, Hydromorphon
Given via epidural
IopamidolDrug
Also called Isovue, Niopam, Solutrast
Given via epidural
Liposomal BupivacaineDrug
Also called Bupivacaine Liposome Injectable Suspension, Exparel
Given injection
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Thoracic Epidural AnalgesiaDrug
Also called TEA, Thoracic Epidural
Undergo thoracic epidural placement
Ultrasound ImagingProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo ultrasound
X-Ray ImagingProcedure or surgery
Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs
Undergo x-ray
| Study group | Role | What they receive |
|---|---|---|
| Group E (TEA) | Experimental | 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. Receives: Drug: Bupivacaine; Drug: Hydromorphone; Drug: Iopamidol; Other: Medical Chart Review; Other: Questionnaire Administration; Drug: Thoracic Epidural Analgesia; Procedure: X-Ray Imaging |
| Group RS (rectus sheath block) | Experimental | Prior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath. Receives: Drug: Bupivacaine; Drug: Liposomal Bupivacaine; Other: Medical Chart Review; Other: Questionnaire Administration; Procedure: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 96 hours after open pancreatoduodenectomy
Secondary outcomes (5)
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.
Measured: At 24, 48, 72 and 96 hours
Hospital length of stay
Average hospital length of stay
Measured: Up to 7 days after surgery
Opioid consumption
Average Opioid consumption (milligrams)
Measured: 96 hours
Time to return of bowel function
Average time to return of bowel function will be measured by first oral intake.
Measured: Up to 7 days after surgery
Incidence of nausea, vomiting, hypotension and pruritis
Measured: At 24 hours, 48 hours, 72 hours and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 Nov 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal NeoplasmStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Flaherty, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411795
- Sponsor's protocol ID
- ANES-2023-31918
- Other IDs
- NCI-2024-02287, ANES-2023-31918, P30CA077598
- Status last verified
- Feb 2026
- First submitted
- 8 May 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06411795
- Acronym / sponsor ID
- ANES-2023-31918
- Conditions
- Duodenal Neoplasm, Pancreatic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E (TEA) | Experimental | Drug: Bupivacaine, Drug: Hydromorphone, Drug: Iopamidol, Other: Medical Chart Review, Other: Questionnaire Administration, Drug: Thoracic Epidural Analgesia, Procedure: X-Ray ImagingPrior 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 RS (rectus sheath block) | Experimental | Drug: Bupivacaine, Drug: Liposomal Bupivacaine, Other: Medical Chart Review, Other: Questionnaire Administration, Procedure: Ultrasound ImagingPrior to pancreatoduodenectomy, patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study
Key exclusion criteria (5 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: AH 250Given via epidural and injection | Drug | Group E (TEA), Group RS (rectus sheath block) |
| HydromorphoneAlso: (-)-Hydromorphone, Dihydromorphinone, HydromorphonGiven via epidural | Drug | Group E (TEA) |
| IopamidolAlso: Isovue, Niopam, SolutrastGiven via epidural | Drug | Group E (TEA) |
| Liposomal BupivacaineAlso: Bupivacaine Liposome Injectable Suspension, ExparelGiven injection | Drug | Group RS (rectus sheath block) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Group E (TEA), Group RS (rectus sheath block) |
| Questionnaire AdministrationAncillary studies | Other | Group E (TEA), Group RS (rectus sheath block) |
| Thoracic Epidural AnalgesiaAlso: TEA, Thoracic EpiduralUndergo thoracic epidural placement | Drug | Group E (TEA) |
| Ultrasound ImagingAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo ultrasound | Procedure or surgery | Group RS (rectus sheath block) |
| X-Ray ImagingAlso: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographsUndergo x-ray | Procedure or surgery | Group E (TEA) |
Primary outcome
Milligram morphine equivalents (MME)
Time frame: Up to 96 hours after open pancreatoduodenectomy
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.
5 secondary outcomes
Pain scores
Time frame: At 24, 48, 72 and 96 hours
Hospital length of stay
Time frame: Up to 7 days after surgery
Opioid consumption
Time frame: 96 hours
Time to return of bowel function
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Flaherty principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine, Hydromorphone and Iopamidol in people with Duodenal Neoplasm and Pancreatic Neoplasm, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Milligram morphine equivalents (MME) (time frame: Up to 96 hours after open pancreatoduodenectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.