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NCT04494880 Clinical Trial

Marcaine Post-Operative Pain Study

Effect of Drug Clinical Trial

Official title:
Marcaine Post-Operative Pain Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04494880
Other study ID # 1618426-3
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date December 9, 2020
Est. completion date December 31, 2022

Study information
Verified date December 2023
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date December 31, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 89 Years
Eligibility Inclusion Criteria: - Must be receiving bilateral breast reduction surgery Exclusion Criteria: - Unilateral breast reduction surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine Injection
Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.

Locations
Country Name City State
United States Upstate University Hospital Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes through study completion, an average of 1 year
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