Clinical trial
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
Name
STUDY00000228
Description
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.
Trial arms
Trial start
2020-12-04
Estimated PCD
2023-04-10
Trial end
2023-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Liposomal bupivacaine
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.
Arms:
Liposomal Bupivicaine
Other names:
Exparel
Bupivacaine, epinephrine, dexamethasone, and clonidine
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
Arms:
Control
Other names:
Standard Preparation
Size
75
Primary endpoint
Pain Score at 48 hours
48 hours
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2023-08-25
1 organization
2 products
1 indication
Organization
Tufts Medical CenterProduct
Liposomal bupivacaineIndication
Breast Cancer