RCT Comparing ESPB Solutions in Breast Surgery

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine; Drug: Liposomal bupivacaine

• Registration Number: NCT04603911
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Study Start: 2020-12-04
• Status Verified: 2023-04
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Bupivacaine, epinephrine, dexamethasone, and clonidine	Control arm will receive standard of care solution for the ESPB block
Liposomal Bupivicaine	Liposomal bupivacaine	Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States