Breast Cancer
Conditions
Keywords
bilateral breast surgery
Brief summary
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.
Interventions
DRUGLiposomal 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.
DRUGBupivacaine, epinephrine, dexamethasone, and clonidine
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours | 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. |
Countries
United States
Outcome results
None listed