Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349140
Recruitment Status : Completed
First Posted : May 6, 2011
Results First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: SKY0402 Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Each subject is assigned two possible doses between 0-80 mg by the investigators based on previous participants' responses to various doses; and, the dominant side is then randomized to either the higher or lower dose. The response for each dose is the primary interest, and not a comparison of the left vs. the right or different dose combinations within each subject. In other words, of interest are the different doses effects on muscle strength and skin sensitivity across participants (eg., Dose A vs Dose B vs Dose C, etc).
Masking: Double
Masking Description: Investigational Drug Service prepared all study medication, with each dose provided to the caregivers in a 30-mL syringe with IV line extension tubing, both wrapped in opaque tape to retain masking since the relative study drug concentration could be inferred by the opacity of the injectate. One syringe was labeled "Dominant" and the other labeled "Other." In this manner, all investigators, nursing staff, and subjects remained masked to the specific concentration/dose during all outcome measurements.
Primary Purpose: Treatment
Official Title: EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks: A Pharmacodynamics Investigation in Healthy Volunteers
Study Start Date : February 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Nerve Block
The dominant side (left or right) will be randomized to one of two treatment groups: the higher or lower concentration of the local anesthetic EXPAREL. The non-dominant contralateral side will receive the other possible treatment. The volume of each and every single-injection femoral nerve block will be 30 mL (standard for femoral nerve blocks is 30-40 mL).3 Since volume will remain constant, we will vary the dose of EXPAREL by varying concentration (volume x concentration = dose). Of note, EXPAREL may be mixed with normal saline to vary the concentration. Randomization will be based on computer-generated codes. Randomization will be in blocks of two, and stratified by sex.
Drug: SKY0402
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.
Other Name: EXPAREL




Primary Outcome Measures :
  1. Quadriceps Femoris Muscle Strength [ Time Frame: Baseline until 99 hours ]
    A dynamometer was used to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90°. The dynamometer was placed on the anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the ipsilateral quadriceps femoris, maintain this effort for 5 seconds, and then relax. The measurements immediately before study drug administration were designated baseline, and all subsequent are expressed as a percentage of the baseline.


Secondary Outcome Measures :
  1. Sensory Effect [ Time Frame: Baseline until 99 hours ]
    We evaluated tolerance of transcutaneous electrical stimulation with the same quantitative procedure as described previously. Electrocardiogram pads were placed 2 cm medial to the distal quadriceps tendon and attached to a nerve stimulator (EZstimII, Model ES400; Life-Tech, Stafford, TX). The current was increased from 0 mA until subjects described mild discomfort, at which time the current was recorded as the tolerated level and the nerve stimulator turned off. All sensory measurements are expressed as a percentage of each patient's pre-infusion baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349140


Locations
Layout table for location information
United States, California
UCSD Medical Center Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Pacira Pharmaceuticals, Inc
Investigators
Layout table for investigator information
Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01349140    
Other Study ID Numbers: EXPAREL Dose-Response
First Posted: May 6, 2011    Key Record Dates
Results First Posted: March 25, 2021
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No