RCT Comparing ESPB Solutions in Breast Surgery

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Bupivacaine; Clonidine; Dexamethasone; Epinephrine

Criteria

Inclusion Criteria:

1. Adults 18 to 75 years of age at screening

2. Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center

Exclusion Criteria:

1. Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)

2. Pregnant women

3. Pregnant minors

4. Woman of childbearing potential who are unwilling or unable to complete a pregnancy test

5. Minors i.e., individuals who are not yet adults (neonates, children, teenagers)

6. Wards of the state

7. Non-viable neonates

8. Neonates of uncertain viability

9. Prisoners

10. Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication