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Local Anesthetic

Pain Management After Breast Reduction

Phase 4

Recruiting

Led By Basel Sharaf, MD, DDS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours post-operatively

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two types of pain relief medicine to see which is better for managing pain.

Who is the study for?

This trial is for adult women aged 18-70 with symptomatic macromastia who are scheduled for breast reduction surgery using a specific incision technique. It's not specified who can't join, but typically those with health conditions affecting the study outcome would be excluded.

What is being tested?

The study compares pain control and opioid use after breast reduction surgery between two drugs: Liposomal Bupivacaine (Exparel) and standard Bupivacaine Hydrochloride. Participants will receive one of these medications to manage post-surgery pain.

What are the potential side effects?

Possible side effects include discomfort at the injection site, nausea, vomiting, constipation from opioids if used for pain relief, and potential allergic reactions to the anesthetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Scores in the first 72 hours post-operatively following breast reduction

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Breast Treatment Group: Liposomal (Exparel) BupivacaineExperimental Treatment2 Interventions

Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.

Group II: Control Breast Treatment Group: Bupivacaine HydrochlorideActive Control1 Intervention

Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal Bupivacaine

2016

Completed Phase 4

~1540

Bupivacaine Hydrochloride

2020