Expired Study
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San Diego, California 92103


Purpose:

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 determine the effect on thigh muscle strength and skin sensitivity of various doses of EXPAREL when placed next to the nerve that goes to the thigh.


Study summary:

Putting local anesthetic next to a nerve is a common way of decreasing the pain that patients feel after surgery. For knee surgery, the local anesthetic is placed next to the femoral nerve in the middle of the crease where the leg meets the body when bending at the hip joint. However, the local anesthetic takes away not only sensation—and therefore pain—but also motor control, leaving muscles weaker. It would greatly improve patient safety if the investigators could administer a very long-acting local anesthetic that decreased postoperative pain, but affected muscle strength only minimally. Currently, the investigators do not know if this is possible with EXPAREL, and the investigators therefore are conducting this study to help determine the dose of EXPAREL that will result in a minimal (20%) decrease in muscle strength.


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.


NCT ID:

NCT01349140


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

San Diego, California 92103
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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