Trials / Completed
CompletedNCT04293809
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
A Phase 1, Pilot, Open Label, Study to Evaluate the Pharmacokinetics, and Safety, of EXPAREL Administered as Pectoral Plane Block in Women Undergoing Breast Augmentation Surgery
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Pacira Pharmaceuticals, Inc · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Exparel Injectable Product | bupivacaine liposome injectable suspension |
| DRUG | Bupivacaine Hydrochloride | 1.3%, 13.3 mg/mL |
Timeline
- Start date
- 2019-12-19
- Primary completion
- 2020-01-15
- Completion
- 2020-01-29
- First posted
- 2020-03-03
- Last updated
- 2024-01-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04293809. Inclusion in this directory is not an endorsement.