EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT01349140
- Run by
- University of California, San Diego
- People needed
- 14
- Starts
- 2012-02-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2021-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- UCSD Medical Center Hillcrest — San Diego, California, United States
Full record on ClinicalTrials.gov
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