- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494880
Marcaine Post-Operative Pain Study
December 14, 2023 updated by: State University of New York - Upstate Medical University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Upstate University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 87 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be receiving bilateral breast reduction surgery
Exclusion Criteria:
- Unilateral breast reduction surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group (Marcaine 1 Breast)
Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
|
Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.
Other Names:
|
No Intervention: Control Group (Marcaine 2 Breasts)
Marcaine will be injected into both breasts as is currently the standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
Time Frame: through study completion, an average of 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Prashant Upadhyaya, MD, SUNY Upstate Medical University - Syracuse, NY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2020
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1618426-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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