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

A Phase 1, Pilot, Open Label, Dose Escalation 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bunion

Interventions

Type	Name	Description
DRUG	Exparel Injectable Product	bupivacaine liposome injectable suspension
DRUG	Bupivacaine	1.3%, 13.3 mg/mL

Timeline

• Start date: 2019-07-26
• Primary completion: 2019-12-02
• Completion: 2019-12-02
• First posted: 2019-06-28
• Last updated: 2021-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study