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Local Anesthetic

Liposomal Bupivacaine for Acute Pain

Phase 4
Recruiting
Led By Jason Habeck, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-75
All patients undergoing partial mastectomy procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from end of surgery through 72 hours after surgery
Awards & highlights

Study Summary

This trial is looking at which of two standard pain control methods is better for breast surgery patients.

Who is the study for?
This trial is for adults aged 18-75 undergoing partial mastectomy procedures. It's not suitable for those on chronic anticoagulation, pregnant, unable to consent, allergic to local anesthetics, non-English speakers, with severe liver disease or coagulopathy, or using daily opioids for over three weeks.Check my eligibility
What is being tested?
The study compares pain control in breast surgery patients using two drugs: liposomal bupivacaine and regular bupivacaine. Each drug will be administered during a guided block of chest muscles to see which one provides better post-surgery pain relief.See study design
What are the potential side effects?
Possible side effects from both liposomal bupivacaine and regular bupivacaine include reactions at the injection site like swelling or itching, nausea, vomiting, dizziness, headache and potential nerve damage if improperly injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am having or have had a partial mastectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from end of surgery through 72 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from end of surgery through 72 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total opioid use
Secondary outcome measures
Maximal pain scores

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: liposomal bupivacaineExperimental Treatment1 Intervention
These patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist.
Group II: bupivacaineActive Control1 Intervention
These patients will receive incisional bupivacaine infiltration by the surgeon.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
liposomal bupivacaine
2016
Completed Phase 4
~610

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,663 Total Patients Enrolled
12 Trials studying Acute Pain
5,125 Patients Enrolled for Acute Pain
Jason Habeck, MDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pec Infiltration With Liposomal Bupivacaine for Breast Surgery
2018. "Pec Infiltration With Liposomal Bupivacaine for Breast Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03599635.
All > Acute Pain > Exparel
~3 spots leftby Jul 2024
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