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Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199574
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : June 29, 2016
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: EXPAREL Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Study Start Date : August 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: EXPAREL
Single administration of EXPAREL 133 mg (10 mL).
 Drug: EXPAREL
133 mg EXPAREL in 10 mL.
Other Name: bupivacaine liposome injectable suspension


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: From time of study drug administration through Day 7 postdose ]
  2. Time to Maximum Plasma Concentration (Tmax) [ Time Frame: From time of study drug administration through Day 7 postdose ]
  3. Area Under the Plasma Concentration Versus Time Curve (AUC(0-t)) [ Time Frame: From time of study drug administration through Day 7 postdose ]
  4. Apparent Terminal Elimination Half-life [ Time Frame: From time of study drug administration through Day 7 postdose ]
  5. Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity)) [ Time Frame: From time of study drug administration through Day 7 postdose ]
  6. The Apparent Terminal Elimination Rate Constant (λz) [ Time Frame: From time of study drug administration through Day 7 postdose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199574


Locations
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United States, Texas
Memorial Hermann - Memorial City Medical Center
Houston, Texas, United States, 77024
Memorial Village Surgery Center
Houston, Texas, United States, 77024
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: Harold Minkowitz, MD Herman Memorial Hospital, Houston TX
More Information
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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02199574    
Other Study ID Numbers: 402-C-401
First Posted: July 24, 2014    Key Record Dates
Results First Posted: June 29, 2016
Last Update Posted: March 8, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents