RCT Comparing ESPB Solutions in Breast Surgery

Tufts University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04603911

STUDY00000228

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

Control

Active Comparator group

Description:

Control arm will receive standard of care solution for the ESPB block

Treatment:

Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine

Liposomal Bupivicaine

Active Comparator group

Description:

Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block

Treatment:

Drug: Liposomal bupivacaine