RCT Comparing ESPB Solutions in Breast Surgery

• ClinicalTrials.gov Identifier: NCT04603911
• Recruitment Status: Recruiting
• First Posted: October 27, 2020
• Last Update Posted: January 25, 2023
• Sponsor: Tufts Medical Center
• Information provided by (Responsible Party): Tufts Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Liposomal bupivacaine; Drug: Bupivacaine, epinephrine, dexamethasone, and clonidine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: December 4, 2020
• Estimated Primary Completion Date: April 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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 Name: 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 Name: Exparel

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sean Gallagher, MD; (617) 636-4526; sgallagher@tuftsmedicalcenter.org

Contact: Sean Gallagher, MD; 617636-4526; sgallagher@tuftsmedicalcenter.org

Locations

United States, Massachusetts

Tufts Medical Center; Recruiting

Boston, Massachusetts, United States, 02111

Contact: Sean Gallagher, MD

Sponsors and Collaborators

Tufts Medical Center

More Information

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT04603911
• Other Study ID Numbers: STUDY00000228
• First Posted: October 27, 2020
• Last Update Posted: January 25, 2023
• Last Verified: January 2023

• 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

Keywords provided by Tufts Medical Center:

bilateral breast surgery

Additional relevant MeSH terms:

Dexamethasone; Clonidine; Epinephrine; Bupivacaine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics