Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty
NCT02713490 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2020-12-11
Summary
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 140 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg).
Conditions
Interventions
- DRUG
-
EXPAREL
EXPAREL and bupivacaine HCl
- DRUG
-
Bupivacaine
Single dose of bupivacaine HCl 0.5%
Sponsors & Collaborators
-
Pacira Pharmaceuticals, Inc
lead INDUSTRY
Principal Investigators
-
James B Jones, MD, PharmD · Pacira Pharmaceuticals, Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-18
- Primary Completion
- 2017-02-08
- Completion
- 2017-02-08
Countries
- United States
Study Locations
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