RCT Comparing ESPB Solutions in Breast Surgery

Sponsor

Tufts Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04603911

Collaborator

(none)

Enrollment

Location

Arms

26.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Dec 4, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 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 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

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

Outcome Measures

Primary Outcome Measures

Pain Score at 48 hours [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

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

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

Tufts Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tufts Medical Center

ClinicalTrials.gov Identifier:

NCT04603911

Other Study ID Numbers:

STUDY00000228

First Posted:

Oct 27, 2020

Last Update Posted:

Jun 2, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Tufts Medical Center

bilateral breast surgery

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022