Trials / Completed
CompletedNCT02199574
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Pacira Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EXPAREL | 133 mg EXPAREL in 10 mL. |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-04-01
- Completion
- 2015-06-01
- First posted
- 2014-07-24
- Last updated
- 2021-03-08
- Results posted
- 2016-06-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02199574. Inclusion in this directory is not an endorsement.