Clinical trial NCT02199574: Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Official title: Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: From time of study drug administration through Day 7 postdose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: From time of study drug administration through Day 7 postdose
measure: Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))
timeFrame: From time of study drug administration through Day 7 postdose
measure: Apparent Terminal Elimination Half-life
timeFrame: From time of study drug administration through Day 7 postdose
measure: Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))
timeFrame: From time of study drug administration through Day 7 postdose
measure: The Apparent Terminal Elimination Rate Constant (λz)
timeFrame: From time of study drug administration through Day 7 postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann - Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Village Surgery Center
state: Texas
Study officials:
affiliation: Herman Memorial Hospital, Houston TX
name: Harold Minkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: