Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Pacira

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: EXPAREL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02199574

402-C-401

Details and patient eligibility

About

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.

Full 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 hours after the beginning of EXPAREL infiltration, and on Day 7.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.