MedTrace Logo

Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery

NCT02713230 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-12-03

Study results available
· View outcomes & findings →

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia

Conditions

Interventions

DRUG

bupivacaine liposome injectable suspension

10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline

DRUG

bupivacaine liposome injectable suspension

20 mL EXPAREL (bupivacaine liposome injectable suspension)

DRUG

Placebo

20 mL normal saline as single-injection

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
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-09
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • United States
  • Belgium
  • Denmark

Study Locations

More Related Trials

Entities

Drugs
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 NCT02713230 on ClinicalTrials.gov