Status:
COMPLETED
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia i...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02199574
Start Date
August 1 2014
End Date
June 1 2015
Last Update
March 8 2021
Active Locations (2)
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1
Memorial Hermann - Memorial City Medical Center
Houston, Texas, United States, 77024
2
Memorial Village Surgery Center
Houston, Texas, United States, 77024