CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Instillation - EXPAREL +1 moredrug
Likely dose
Instillation - EXPAREL 325 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.

Search/NCT01582490
NCT01582490Phase 4Completed
CompareCT.gov

Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty

Pacira Pharmaceuticals, Inc·interventional·Posted Apr 20, 2012·Updated Jul 2, 2014

In Brief

A Phase 4 clinical trial evaluating Instillation - EXPAREL and Infiltration - EXPAREL for Mammoplasty and Postoperative Pain. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMammoplasty, Postoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.2 years ago

Interventions

Instillation - EXPARELdrug

Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Infiltration - EXPARELdrug

IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.