At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 232 enrolled
Drug / intervention
bupivacaine liposome injectable suspension +1 moredrug
Likely dose
bupivacaine liposome injectable suspension 133 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating bupivacaine liposome injectable suspension and Placebo for Pain. Completed, enrolled 232 participants across 17 sites in 3 countries.
Detailed Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 232 adult subjects undergoing primary unilateral TKA under general or spinal anesthesia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBelgium, Denmark, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartJun 2016
Primary CompletionJun 2017
TodayJul 2026
First PostedMar 18, 2016
Enrollment StartJun 3, 2016
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.3 years ago
Interventions
bupivacaine liposome injectable suspensiondrug
bupivacaine liposome injectable suspension 133 mg expanded with normal saline to 20 mL or 266 mg in 20 mL
Placebodrug
Normal saline.