Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: EXPAREL

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77024
      • Memorial Hermann - Memorial City Medical Center
    • Houston, Texas, United States, 77024
      • Memorial Village Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPAREL; Single administration of EXPAREL 133 mg (10 mL).	Drug: EXPAREL; 133 mg EXPAREL in 10 mL.; Other Names: bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax)	From time of study drug administration through Day 7 postdose
Time to Maximum Plasma Concentration (Tmax)	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
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

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Harold Minkowitz, MD, Herman Memorial Hospital, Houston TX

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 402-C-401