CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Group 1 Standard of Care +1 moredrug
Likely dose
Group 2 EXPAREL 266 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/NCT01509638
NCT01509638Phase 4Completed
CompareCT.gov

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal

Pacira Pharmaceuticals, Inc·interventional·Posted Jan 13, 2012·Updated Mar 6, 2014

In Brief

A Phase 4 clinical trial evaluating Group 1 Standard of Care and Group 2 EXPAREL for Retraction of Colostomy. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetraction of Colostomy
CountriesUnited States
CollaboratorsRegistrat-Mapi

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartMar 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago

Interventions

Group 1 Standard of Caredrug

Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.

Group 2 EXPARELdrug

Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.