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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
75
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.
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
Tufts Medical Center
Boston, Massachusetts, United States
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.
Time frame: 48 hours
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.
Time frame: 72 hours
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