Clinical trial · Interventional
RCT Comparing ESPB Solutions in Breast Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine, epinephrine, dexamethasone, and clonidine | Drug | — | UNRESOLVED |
| Liposomal bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Control arm will receive standard of care solution for the ESPB block
- interventionNames
- Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine
- type
- ACTIVE_COMPARATOR
- label
- Liposomal Bupivicaine
- description
- Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block
- interventionNames
- Drug: Liposomal bupivacaine
Primary outcomes (1)
- measure
- Pain Score at 48 hours
- timeFrame
- 48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available