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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post op
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am having breast reconstruction with implants or tissue expanders.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid consumption
Secondary outcome measures
Mobility
Nausea
Pain Outcomes

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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,141 Total Patients Enrolled
Pacira Pharmaceuticals, IncIndustry Sponsor
135 Previous Clinical Trials
13,913 Total Patients Enrolled
Robert Galiano, MDPrincipal Investigator3126956022
4 Previous Clinical Trials
390 Total Patients Enrolled

Media Library

Breast Reconstruction (Mammaplasty) Clinical Trial Eligibility Overview. Trial Name: NCT05171179 — Phase 3
Breast Reduction Surgery Research Study Groups: Intravenous lidocaine, Blocks+Bupivacaine, Blocks+Bupivacaine+Exparel
Breast Reduction Surgery Clinical Trial 2023: Breast Reconstruction (Mammaplasty) Highlights & Side Effects. Trial Name: NCT05171179 — Phase 3
Breast Reconstruction (Mammaplasty) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05171179 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are currently registered for this clinical trial?

"That is accurate, the information available on clinicaltrials.gov stipulates that the trial is open and presently looking for 90 patients at a single site. The trial was firstposted on 10/22/2021 and was last edited on 10/7/2022."

Answered by AI

Are there precedents for this type of Breast Reconstruction (Mammaplasty)?

"As of now, there are 243 ongoing clinical trials for Breast Reconstruction (Mammaplasty), 53 of which are in Phase 3. Although the majority of these studies originate from Germantown, Tennessee, there are 1237 locations across the world running these trials."

Answered by AI

What condition is Breast Reconstruction (Mammaplasty) usually employed to correct?

"Breast Reconstruction (Mammaplasty) is commonly used to treat minor burns, but can also help patients with lupus erythematosus cell, ulcerative colitis, and transplantation."

Answered by AI

What are the most common risks associated with Breast Reconstruction surgery?

"Breast Reconstruction (Mammaplasty) received a score of 3 on the Power scale due to Phase 3 trial data supporting both efficacy and safety."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern Memorial Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
Robert Galiano 2021. "The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05171179.
~26 spots leftby Apr 2025
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