A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Pacira Pharmaceuticals
  • Most Recent Events

    • 09 Sep 2017 This trial has been completed in Denmark (end date: 27 Jun 2017).
    • 06 Sep 2017 The trial has been completed in Belgium (End Date:2017-06-27).
    • 02 Aug 2017 According to a Pacira Pharmaceuticals media release, the results of this and another phase III trial (see CT 269389) safety and pharmacokinetic data through 120 days, and data from other peripheral nerve block comparator studies will serve as the basis of an sNDA submission to the US FDA later this year, seeking expansion of the EXPAREL label to include administration via nerve block.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top