Phase 1 N=14 Double-blind Treatment

EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01349140 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Quadriceps Femoris Muscle Strength — NA; NA; 9; 13 percentage of baseline measurement

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: SKY0402 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Quadriceps Femoris Muscle Strength	NA; NA; 9; 13; 12; NA	—
SECONDARY Sensory Effect	127; 275; 486; 209; 400; NA	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01349140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.