At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
EXPARELdrug
Likely dose
EXPAREL 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.
Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
In Brief
A Phase 4 clinical trial evaluating EXPAREL for Pain. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionApr 2015
Study CompletionJun 2015
TodayJul 2026
First PostedJul 24, 2014
Enrollment StartAug 1, 2014
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.9 years ago
Interventions
EXPARELdrug
133 mg EXPAREL in 10 mL.