Clinical Trial: EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)



Original Primary Outcome: The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use [ Time Frame: 10 days ]

Current Secondary Outcome: The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30. [ Time Frame: 30 days ]

Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.


Original Secondary Outcome: The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30. [ Time Frame: 30 days ]

Information By: Pacira Pharmaceuticals, Inc

Dates:
Date Received: February 26, 2013
Date Started: April 2012
Date Completion:
Last Updated: July 2, 2013
Last Verified: July 2013