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Completed

NCT Number: NCT04603911

RCT Comparing ESPB Solutions in 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Exparel

Bupivacaine, epinephrine, dexamethasone, and clonidine

Drug

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

Other names: Standard Preparation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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