A Phase 2 interventional study of Liposomal bupivacaine and Bupivacaine, epinephrine, dexamethasone, and clonidine in Breast Cancer, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Tufts Medical Center · Phase 2, Interventional, and Other
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 29 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 16 (52%) have results posted.
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Exclusion Criteria:
Control arm will receive standard of care solution for the ESPB block
Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine
Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block
Drug: 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.
Also known as: Exparel
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
Also known as: Standard Preparation
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
Ran from Dec 2020 to primary completion in Apr 2023, 28 months.
Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's 28 months is below that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine