EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Pacira Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• greater than or equal to 18 years old

• able and willing to have bilateral femoral nerve blocks placed and repeated motor/sensory testing for 24-120 hours (1-5 days), requiring 1-5 overnight stay(s) in the UCSD CTRI to allow dissipation of local anesthetic infusion effects to near-baseline values

• have the ability to adequately communicate with all study personnel

• willing and capable of providing written informed consent

Exclusion Criteria:

• daily analgesic use for over one week within the past 6 months

• opioid use within the previous 4 weeks

• any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

• body mass index > 30 kg/m2

• current pregnancy

• incarceration

• any coagulation disorder

• uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigators, may interfere with study assessments or adherence

• any previous allergic reaction to fentanyl, midazolam, or an amide local anesthetic (bupivacaine is of the amide local anesthetic class)

• any previous participation in a SKY0402/EXPAREL study

• nursing mothers

• suspected or known drug or alcohol abuse within the previous year; and/or

• planning on becoming pregnant in the one month following study participation.