Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:August 2014
Contact:Kay Warnott
Email:kay.warnott@pacira.com
Phone:973-254-4305

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The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single
dose of EXPAREL (266 mg/20 mL) administered intraoperatively per normal infiltration for
prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of
the adenoids.

Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within
30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24,
36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.

Inclusion Criteria:

- Male or female, ≥18 years of age at the Screening Visit.

- Subjects undergoing tonsillectomy with or without removal of the adenoids.

- Able and willing to comply with all study visits and procedures.

- Willing and capable of providing written informed consent.

Exclusion Criteria:

- History of hypersensitivity or idiosyncratic reaction to amide-type local
anesthetics.

- Received any investigational drug within 30 days prior to EXPAREL administration,
and/or has planned administration of another investigational product or procedure
while participating in this study.

- Currently pregnant, nursing, or planning to become pregnant during the study or
within 1 month after EXPAREL administration. Female subjects must be surgically
sterile, at least 2 years postmenopausal, or using an acceptable method of birth
control. If of childbearing potential, must have a documented negative pregnancy
test within 24 hours before EXPAREL administration.

- Subjects with significant medical conditions or laboratory results that, in the
opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or
procedures, or cause inability to comply with the study requirements.
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Houston, Texas 77024
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