Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Pain Clinical Trial

Official title:

Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199574
• Other study ID #: 402-C-401
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2021
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• EXPAREL
133 mg EXPAREL in 10 mL.

Locations

Country	Name	City	State
United States	Memorial Hermann - Memorial City Medical Center	Houston	Texas
United States	Memorial Village Surgery Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)		From time of study drug administration through Day 7 postdose
Primary	Time to Maximum Plasma Concentration (Tmax)		From time of study drug administration through Day 7 postdose
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))		From time of study drug administration through Day 7 postdose
Primary	Apparent Terminal Elimination Half-life		From time of study drug administration through Day 7 postdose
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))		From time of study drug administration through Day 7 postdose
Primary	The Apparent Terminal Elimination Rate Constant (?z)		From time of study drug administration through Day 7 postdose