CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
IV morphine sulfate +1 moredrug
Likely dose
EXPAREL (bupivacaine liposome injectable suspension) 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/NCT01507246
NCT01507246Phase 4Completed

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 Open Colectomy

Pacira Pharmaceuticals, Inc·interventional·Posted Jan 10, 2012·Updated May 8, 2013

In Brief

A Phase 4 clinical trial evaluating IV morphine sulfate and EXPAREL (bupivacaine liposome injectable suspension) for Bowel Obstruction. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This study is designed to compare the standard of care against EXPAREL(R) 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--
CountriesUnited States
CollaboratorsRegistrat-Mapi

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2012
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago

Interventions

IV morphine sulfatedrug

Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.

EXPAREL (bupivacaine liposome injectable suspension)drug

Patients 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, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.