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

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