At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 156 enrolled
Drug / intervention
bupivacaine liposome injectable suspension +2 moredrug
Likely dose
bupivacaine liposome injectable suspension 10 mLfrom 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 Brachial Plexus Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair
In Brief
A Phase 3 clinical trial evaluating bupivacaine liposome injectable suspension and Placebo for Pain. Completed, enrolled 156 participants across 20 sites in 3 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesBelgium, Denmark, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2016
Primary CompletionJul 2017
TodayJul 2026
First PostedMar 18, 2016
Enrollment StartMay 9, 2016
Primary CompletionJul 7, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.3 years ago
Interventions
bupivacaine liposome injectable suspensiondrug
10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline
bupivacaine liposome injectable suspensiondrug
20 mL EXPAREL (bupivacaine liposome injectable suspension)
Placebodrug
20 mL normal saline as single-injection