Trial Title:
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
NCT ID:
NCT06411795
Condition:
Duodenal Neoplasm
Pancreatic Neoplasm
Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Hydromorphone
Bupivacaine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Patients and providers will not be blinded to the analgesic technique
Intervention:
Intervention type:
Drug
Intervention name:
Bupivacaine
Description:
Given via epidural and injection
Arm group label:
Group E (TEA)
Arm group label:
Group RS (rectus sheath block)
Other name:
AH 250
Intervention type:
Drug
Intervention name:
Hydromorphone
Description:
Given via epidural
Arm group label:
Group E (TEA)
Other name:
(-)-Hydromorphone
Other name:
Dihydromorphinone
Other name:
Hydromorphon
Intervention type:
Drug
Intervention name:
Iopamidol
Description:
Given via epidural
Arm group label:
Group E (TEA)
Other name:
Isovue
Other name:
Niopam
Other name:
Solutrast
Intervention type:
Drug
Intervention name:
Liposomal Bupivacaine
Description:
Given injection
Arm group label:
Group RS (rectus sheath block)
Other name:
Bupivacaine Liposome Injectable Suspension
Other name:
Exparel
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Ancillary studies
Arm group label:
Group E (TEA)
Arm group label:
Group RS (rectus sheath block)
Other name:
Chart Review
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group E (TEA)
Arm group label:
Group RS (rectus sheath block)
Intervention type:
Drug
Intervention name:
Thoracic Epidural Analgesia
Description:
Undergo thoracic epidural placement
Arm group label:
Group E (TEA)
Other name:
TEA
Other name:
Thoracic Epidural
Intervention type:
Procedure
Intervention name:
Ultrasound Imaging
Description:
Undergo ultrasound
Arm group label:
Group RS (rectus sheath block)
Other name:
2-Dimensional Grayscale Ultrasound Imaging
Other name:
2-Dimensional Ultrasound Imaging
Other name:
2D-US
Other name:
Ultrasonography
Other name:
Ultrasound
Other name:
Ultrasound Test
Other name:
Ultrasound, Medical
Other name:
US
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo x-ray
Arm group label:
Group E (TEA)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiographic imaging procedure (procedure)
Other name:
Radiography
Other name:
RG
Other name:
Static X-Ray
Other name:
X-Ray
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the
University of Minnesota will be included in the study
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Minnesota/Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Flaherty
Phone:
314-322-3474
Email:
jflahert@umn.edu
Investigator:
Last name:
James Flaherty
Email:
Principal Investigator
Start date:
November 10, 2023
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Masonic Cancer Center, University of Minnesota
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Masonic Cancer Center, University of Minnesota
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06411795
