Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pacira Pharmaceuticals, Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
