EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair (702)
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Abdominal Hernia Repair|
- 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 ] [ Designated as safety issue: No ]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)
- The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
undiluted EXPAREL 266 mg
single dose 266 mg of undiluted EXPAREL
Other Name: bupivacaine liposome injectable suspension
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801124
|United States, New York|
|Maimonides Medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Mark Kronenfeld, MD||Maimonides|