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OpenTrials
Completed

NCT Number: NCT04494880

Marcaine Post-Operative Pain Study

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.

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Key information

Conditions

Effect of Drug

Age range

Up to 89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Upstate University Hospital

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be receiving bilateral breast reduction surgery

Exclusion criteria

  • Unilateral breast reduction surgery

Treatment and study plan

Bupivacaine Injection

Drug

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

Other names: Marcaine

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2020
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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