CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
IV morphine sulfate or Sponsor-approved equivalent +1 moredrug
Likely dose
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/NCT01509807
NCT01509807Phase 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 Apr 7, 2014

In Brief

A Phase 4 clinical trial evaluating IV morphine sulfate or Sponsor-approved equivalent and EXPAREL for Retraction of Colostomy. Completed, enrolled 33 participants across 3 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 StartJan 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.5 years ago

Interventions

IV morphine sulfate or Sponsor-approved equivalentdrug

Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.

EXPARELdrug

Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc 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.