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A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

NCT01509807 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-04-07

Study results available
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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.

Conditions

  • Retraction of Colostomy

Interventions

DRUG

IV morphine sulfate or Sponsor-approved equivalent

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

DRUG

EXPAREL

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.

Sponsors & Collaborators

  • Registrat-Mapi

    collaborator OTHER

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Jorge Marcet, MD · University of South Florida, Tampa, FL

  • Valentine Nfonsam, MD · University of Arizona, Tucson, AZ

  • Sergio Larach, MD · Florida Hospital, Orlando, FL.

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509807 on ClinicalTrials.gov