Marcaine Post-Operative Pain Study

NCT ID: NCT04494880

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment Group (Marcaine 1 Breast)

Marcaine will be injected into one randomized breast and saline into the other in the treatment group.

Group Type EXPERIMENTAL

Bupivacaine Injection

Intervention Type DRUG

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

Control Group (Marcaine 2 Breasts)

Marcaine will be injected into both breasts as is currently the standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine Injection

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

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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Inclusion Criteria

* Must be receiving bilateral breast reduction surgery

Exclusion Criteria

* Unilateral breast reduction surgery
Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashant Upadhyaya, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Upstate Medical University - Syracuse, NY

Locations

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Upstate University Hospital

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1618426-3

Identifier Type: -

Identifier Source: org_study_id