Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: EXPAREL

• Registration Number: NCT02199574
• Lead Sponsor: Pacira Pharmaceuticals, Inc

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

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

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Study Start: 2014-08
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Results First Submitted: 2016-05-20
• Results First Submitted QC: 2016-05-20
• Results First Posted: 2016-06-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EXPAREL	EXPAREL	Single administration of EXPAREL 133 mg (10 mL).

Primary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration (Tmax)	From time of study drug administration through Day 7 postdose
Apparent Terminal Elimination Half-life	From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))	From time of study drug administration through Day 7 postdose
The Apparent Terminal Elimination Rate Constant (λz)	From time of study drug administration through Day 7 postdose
Maximum Plasma Concentration (Cmax)	From time of study drug administration through Day 7 postdose
Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))	From time of study drug administration through Day 7 postdose

Trial Locations

Locations (2)

Memorial Hermann - Memorial City Medical Center; 🇺🇸 Houston, Texas, United States

Memorial Village Surgery Center; 🇺🇸 Houston, Texas, United States