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

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713490 on ClinicalTrials.gov