drugset / Trial / NCT04002089
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa). A total of 10 subjects will be enrolled in each of the 4 cohorts.
Timeline
- Start
- 2019-07-26
- Primary completion
- 2019-12-02
- Completion
- 2019-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 100 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 133 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 266 mg | Other |