RCT Comparing ESPB Solutions in Breast Surgery

Study Overview
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Brief Summary
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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.

Official Title
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An Investigator-Initiated, Double-Blind, Patient-Controlled, Randomized Control Trial Comparing the Effectiveness of Liposomal Bupivacaine to a Solution of Bupivacaine, Epinephrine Clonidine and Dexamethasone in Bilateral, Single Shot, Erector Spinae Plane Blocks During Oncoplastic Breast Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control arm will receive standard of care solution for the ESPB block | Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine<br>* The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.<br>* Other names: Standard Preparation;|
| Active Comparator: Liposomal Bupivicaine<br>Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block | Drug: Liposomal bupivacaine<br>* The liposomal bupivacaine used in the research study has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for pain management. The specific approved uses are postsurgical single-dose wound infiltration analgesia and brachial plexus nerve block. In this study, we will be using liposomal bupivacaine in an additional way by infiltrating liposomal bupivacaine in a tissue plane to numb the nerves that provide sensation over the chest.<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at 48 hours | Pain score will be recorded using a visual analogue scale (VAS) where 0 is no pain and 10 is unbearable pain. Pain will be recorded for the right and left side independently. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours | Pain score will be recorded using a visual analogue scale (VAS) where 0 is no pain and 10 is unbearable pain. Pain will be recorded for the right and left side independently. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilateral breast surgery