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Completed

NCT Number: NCT02199574

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Memorial Hermann - Memorial City Medical Center, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel

Drug

133 mg EXPAREL in 10 mL.

Other names: bupivacaine liposome injectable suspension

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2014
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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