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Liposomal Bupivacaine for Peripheral Arterial Disease

Phase 4
Recruiting
Led By Tiziano Tallarita, MD
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 28 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to see if liposomal bupivacaine injections can reduce the need for painkiller drugs during and after lower limb revascularization surgery.

Who is the study for?
This trial is for English-speaking individuals scheduled for elective lower extremity revascularization surgery who are not on opioids for more than a week, do not have chronic pain, and have no allergies to local anesthetics or contraindications to regional anesthesia.
What is being tested?
The study is testing if injections of liposomal bupivacaine can reduce the need for narcotic drugs during and after leg artery surgery. Participants will either receive the actual drug or a placebo without knowing which one they get.
What are the potential side effects?
Liposomal bupivacaine may cause side effects such as numbness in the area of injection, low blood pressure, nausea, vomiting, backache, headache or dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative use of narcotics at 12 hours
Postoperative use of narcotics at 24 hours
Postoperative use of narcotics at 30 days
+2 more
Secondary study objectives
Hospital Length of Stay
Intraoperative use of narcotics
Postoperative quality of recovery at 14 days
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liposomal Bupivacaine GroupExperimental Treatment1 Intervention
Subjects will receive an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will receive an injection of placebo during clinically indicated lower extremity revascularization surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine liposome
2016
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,155 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
260 Patients Enrolled for Peripheral Arterial Disease
Tiziano Tallarita, MDPrincipal InvestigatorMayo Clinic

Media Library

Liposomal Bupivacaine Group Clinical Trial Eligibility Overview. Trial Name: NCT05992896 — Phase 4
Peripheral Arterial Disease Research Study Groups: Placebo Group, Liposomal Bupivacaine Group
Peripheral Arterial Disease Clinical Trial 2023: Liposomal Bupivacaine Group Highlights & Side Effects. Trial Name: NCT05992896 — Phase 4
Liposomal Bupivacaine Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05992896 — Phase 4
~0 spots leftby Nov 2024
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