RCT Comparing ESPB Solutions in Breast Surgery

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04603911
• Other study ID #: STUDY00000228
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 4, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• Bupivacaine, epinephrine, dexamethasone, and clonidine
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours
Secondary	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.	72 hours