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A Study of Loco-Regional Liposomal Bupivacaine Injection

NCT05992896 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-07-03

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Bupivacaine liposome

Injection into pelvic area and into the edges of wound at the end of the procedure.

DRUG

Placebo

Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .

Sponsors & Collaborators

Principal Investigators

  • Tiziano Tallarita, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2025-05-15
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05992896 on ClinicalTrials.gov