RCT Comparing ESPB Solutions in Breast Surgery

NCT ID: NCT04603911

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2023-04-10

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Control

Control arm will receive standard of care solution for the ESPB block

Group Type: ACTIVE_COMPARATOR

Bupivacaine, epinephrine, dexamethasone, and clonidine

Intervention Type: DRUG

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

Liposomal Bupivicaine

Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block

Group Type: ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Bupivacaine, epinephrine, dexamethasone, and clonidine

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

Intervention Type: DRUG

Other Intervention Names

Exparel; Standard Preparation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00000228

Identifier Type: -

Identifier Source: org_study_id