Phase 4
N=12
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02199574 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 254 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EXPAREL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pacira Pharmaceuticals, Inc
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
254 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) |
0.50 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC(0-t)) |
7150 | — |
| PRIMARY Apparent Terminal Elimination Half-life |
9.34 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity)) |
6379 | — |
| PRIMARY The Apparent Terminal Elimination Rate Constant (λz) |
0.07779 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02199574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.