Marcaine Post-Operative Pain Study

Early Phase 1

Completed

• Conditions: Effect of Drug
• Interventions: Drug: Bupivacaine Injection

• Registration Number: NCT04494880
• Lead Sponsor: State University of New York - Upstate Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2020-12-09
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Must be receiving bilateral breast reduction surgery

Exclusion Criteria

• Unilateral breast reduction surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group (Marcaine 1 Breast)	Bupivacaine Injection	Marcaine will be injected into one randomized breast and saline into the other in the treatment group.

Primary Outcome Measures

Name	Time	Method
Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast	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

Trial Locations

Locations (1)

Upstate University Hospital; 🇺🇸 Syracuse, New York, United States