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. Identifier: NCT01349140
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : August 8, 2012
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 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.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Drug: SKY0402 Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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: For the 10 hours after the nerve blocks are placed, the left and right thighs will be tested as described below. ]
    While seated, participants will be asked to push their right foot forward against a machine which gives resistance (as if they were kicking slowly), and this machine will measure the strength in their thigh muscles.

Secondary Outcome Measures :
  1. Sensory level [ Time Frame: For the 10 hours after the nerve blocks are placed, the left and right thighs will be tested as described below. ]
    Two small electrode pads are placed near the top of one knee cap; and a small electrical current increased until the participant feels slight discomfort. These procedures will be repeated on the other side as well.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT01349140

United States, California
UCSD Medical Center Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Pacira Pharmaceuticals, Inc

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego Identifier: NCT01349140     History of Changes
Other Study ID Numbers: EXPAREL Dose-Response
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012