RCT Comparing ESPB Solutions in Breast Surgery

January 8, 2025 updated by: Tufts Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Control arm will receive standard of care solution for the ESPB block
Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine
The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
Other Names:
  • Standard Preparation
Active Comparator: Liposomal Bupivicaine
Liposomal Bupivicaine arm will receive Liposomal Bupivicaine for the ESPB block
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.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score at 48 hours
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000228

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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