EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
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|ClinicalTrials.gov Identifier: NCT01349140|
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : August 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Analgesia||Drug: SKY0402||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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.
- 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.
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
|United States, California|
|UCSD Medical Center Hillcrest|
|San Diego, California, United States, 92103|