Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

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.