RCT Comparing ESPB Solutions in Breast Surgery

NCT04603911 | Completed Phase 2 FDA Drug

• 1 other identifier: STUDY00000228
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

bilateral breast surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours

  72 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine

Liposomal Bupivicaine

ACTIVE COMPARATOR

Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine 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.

Also known as: Exparel

Liposomal Bupivicaine

Bupivacaine, epinephrine, dexamethasone, and clonidine DRUG

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

Also known as: Standard Preparation

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 to 75 years of age at screening
• Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center

You may not qualify if:

• Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)
• Pregnant women
• Pregnant minors
• Woman of childbearing potential who are unwilling or unable to complete a pregnancy test
• Minors i.e., individuals who are not yet adults (neonates, children, teenagers)
• Wards of the state
• Non-viable neonates
• Neonates of uncertain viability
• Prisoners
• Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bupivacaine; Epinephrine; Dexamethasone; Clonidine; Reference Standards

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Weights and Measures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: December 4, 2020
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: January 10, 2025

Record last verified: 2023-04

Locations

US (1)