At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks: A Pharmacodynamics Investigation in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating SKY0402 for Healthy Volunteers. Completed, enrolled 14 participants across 1 site.
Detailed Summary
EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
Study Details
Timeline
Interventions
Single-injection femoral nerve block. Initial doses of SKY0402 will begin at 0 mg, and 2 mg (high) for the first subject; and 1 mg (low) and 3 mg (high) for the second subject. The next doses will be between 0-80 mg per side, determined prior to randomization of each subsequent subject. The specific subsequent doses will increase, remain the same, or decrease, determined by the P.I. in consultation with the manufacturer of SKY0402. Doses will always remain within the range of 0-80 mg per side, for a total possible dose of 0-160 mg.