Marcaine Post-Operative Pain Study
Overview
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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: December 1, 2022
Interventions
- Drug: Bupivacaine Injection
- Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.
Arms, Groups and Cohorts
- Experimental: Treatment Group (Marcaine 1 Breast)
- Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
- No Intervention: Control Group (Marcaine 2 Breasts)
- Marcaine will be injected into both breasts as is currently the standard of care.
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
Inclusion Criteria
- Must be receiving bilateral breast reduction surgery Exclusion Criteria:
- Unilateral breast reduction surgery
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 89 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- State University of New York – Upstate Medical University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Prashant Upadhyaya, MD, Principal Investigator, SUNY Upstate Medical University – Syracuse, NY
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.