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RCT Comparing ESPB Solutions in Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603911
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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

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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
Estimated Study Start Date : December 4, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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




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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603911


Contacts
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Contact: Sean Gallagher, MD (617) 636-4526 sgallagher@tuftsmedicalcenter.org
Contact: Sean Gallagher, MD 617636-4526 sgallagher@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Sean Gallagher, MD         
Sponsors and Collaborators
Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04603911    
Other Study ID Numbers: STUDY00000228
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: October 2020

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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:
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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