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Pecs Blocks + Exparel for Breast Reduction Surgery

Phase 3

Recruiting

Led By Robert Galiano, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Subjects who are undergoing implant-based, tissue expander breast reconstruction surgery

Be older than 18 years old

Must not have

Subjects undergoing direct-to-implant surgery

Subjects undergoing flap breast reconstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks post op

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will investigate whether Pecs blocks can reduce post-operative pain, opioid use, and nausea in patients who have undergone breast reconstruction surgery.

Who is the study for?

This trial is for individuals over 18 years old who are having implant-based, tissue expander breast reconstruction surgery. It's not suitable for those with prior radiation therapy, direct-to-implant or flap reconstruction surgeries, pregnant women, or anyone with conditions that could risk participation or skew results.

What is being tested?

The study examines the effectiveness of Pecs blocks combined with Exparel in managing pain after breast reconstruction surgery. The goal is to see if this method reduces post-operative pain and opioid use while improving physical activity without using opioids.

What are the potential side effects?

Potential side effects may include discomfort at the injection site from Pecs blocks and Exparel, possible allergic reactions to local anesthetics like Bupivacaine and Lidocaine, and less commonly nausea or reduced sensation around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having breast reconstruction with implants or tissue expanders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am having surgery to place breast implants without tissue expanders.

Select...

I am having breast reconstruction using the flap technique.

Select...

I have had radiation therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post op for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Opioid consumption

Secondary study objectives

Mobility

Nausea

Pain Outcomes

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

3Treatment groups

Experimental Treatment

Active Control

Group I: Intravenous lidocaineExperimental Treatment2 Interventions

Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)

Group II: Blocks+Bupivacaine+ExparelExperimental Treatment4 Interventions

Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)

Group III: Blocks+BupivacaineActive Control3 Interventions

Use of Pecs block types I and II with bupivacaine as local anesthetic

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

FDA approved

Bupivacaine

FDA approved

Lidocaine

FDA approved