Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy

Pancreatic Neoplasm Clinical Trial

Official title:

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411795
• Other study ID #: ANES-2023-31918
• Secondary ID: NCI-2024-02287AN
• Status: Recruiting
• Phase: Phase 2
• Start date: November 10, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Neoplasm
• Duodenal Neoplasms
• Neoplasms
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Drug:
• Bupivacaine
Given via epidural and injection
• Hydromorphone
Given via epidural
• Iopamidol
Given via epidural
• Liposomal Bupivacaine
Given injection

Other:
• Medical Chart Review
Ancillary studies
• Questionnaire Administration
Ancillary studies

Drug:
• Thoracic Epidural Analgesia
Undergo thoracic epidural placement

Procedure:
• Ultrasound Imaging
Undergo ultrasound
• X-Ray Imaging
Undergo x-ray

Locations

Country	Name	City	State
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 96 hours after open pancreatoduodenectomy
Secondary	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.	At 24, 48, 72 and 96 hours
Secondary	Hospital length of stay	Average hospital length of stay	Up to 7 days after surgery
Secondary	Opioid consumption	Average Opioid consumption (milligrams)	96 hours
Secondary	Time to return of bowel function	Average time to return of bowel function will be measured by first oral intake.	Up to 7 days after surgery
Secondary	Incidence of nausea, vomiting, hypotension and pruritis		At 24 hours, 48 hours, 72 hours and 96 hours