~1 spots leftby May 2025

Liposomal Bupivacaine for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)
Overseen byTiziano Tallarita, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Mayo Clinic
Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this research is to find out if using liposomal bupivacaine solution (bupivacaine liposome) injections during lower extremity revascularization surgery will lower the amount of narcotic drugs used during and following the procedure.

Eligibility Criteria

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.

Inclusion Criteria

You are scheduled for a planned surgery to improve blood flow in your legs.

Exclusion Criteria

Non-English speaking
Long-lasting pain
You have been taking opioid medications for more than 1 week.
+5 more

Participant Groups

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.
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Mayo Clinic Health System - Eau ClaireEau Claire, WI
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Who Is Running the Clinical Trial?

Mayo ClinicLead Sponsor

References