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A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

NCT02058290 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-05-14

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 hospital costs.

Conditions

  • Bowel Obstruction

Interventions

DRUG

IV morphine sulfate or Sponsor-approved equivalent

Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour.

DRUG

EXPAREL

Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc 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.

Sponsors & Collaborators

  • Registrat-Mapi

    collaborator OTHER

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Edward C Lee, MD · Albany Medical College

  • Keith Candiotti, MD · University of Miami

  • Sergio Bergese, MD · Ohio State University

  • Eric M Haas, MD · The Methodist Hospital Research Institute

  • Jorge Marcet, MD · Tampa General Hospital

  • Anjali Kumar, MD · Medstar Health Research Institute

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
2011-12-31
Primary Completion
2012-09-30
Completion
2013-02-28

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 NCT02058290 on ClinicalTrials.gov