Breast Cancer Clinical Trial

RCT Comparing ESPB Solutions in Breast Surgery

Summary

The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults 18 to 75 years of age at screening
Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center

Exclusion Criteria:

Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)
Pregnant women
Pregnant minors
Woman of childbearing potential who are unwilling or unable to complete a pregnancy test
Minors i.e., individuals who are not yet adults (neonates, children, teenagers)
Wards of the state
Non-viable neonates
Neonates of uncertain viability
Prisoners
Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT04603911

Recruitment Status:

Recruiting

Sponsor:

Tufts Medical Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Sean Gallagher, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT04603911

Recruitment Status:

Recruiting

Sponsor:


Tufts Medical Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.