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Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

Primary Purpose

Pain, Postoperative

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Depodur
Sponsored by
Drexel University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring OP-CABG, Depodur traditional drug

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female, 18-99 years old
  • All patients who will have surgery for OP-CABG

Exclusion Criteria:

  • Pregnant females
  • Patients with allergy to morphine
  • Patients nursing an infant
  • Patients with migraine headaches
  • Patients taking Coumadin within 7 days or demonstrating INR > 13
  • Patients taking Heparin unless documented normal partial thromboplastin time
  • Patients taking Clopidogrel in previous 7 days
  • Patients taking Ticlopidine in previous 14 days
  • Patients taking Aspirin in previous 48 hours
  • Patients receiving low molecular weight heparin therapy within 24 hours previous
  • Patients with Narcolepsy and/or sleep apnea
  • Patients on chronic opioid therapy
  • Patients participating in another study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Depodur

    Traditional

    Arm Description

    Depodur arm

    traditional management

    Outcomes

    Primary Outcome Measures

    Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2007
    Last Updated
    August 13, 2014
    Sponsor
    Drexel University College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00456638
    Brief Title
    Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
    Official Title
    Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Difficulty aquiring investigational drug
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Drexel University College of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.
    Detailed Description
    The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    OP-CABG, Depodur traditional drug

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Depodur
    Arm Type
    Experimental
    Arm Description
    Depodur arm
    Arm Title
    Traditional
    Arm Type
    Active Comparator
    Arm Description
    traditional management
    Intervention Type
    Drug
    Intervention Name(s)
    Depodur
    Other Intervention Name(s)
    Traditional
    Intervention Description
    Depodur vs. traditional management
    Primary Outcome Measure Information:
    Title
    Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female, 18-99 years old All patients who will have surgery for OP-CABG Exclusion Criteria: Pregnant females Patients with allergy to morphine Patients nursing an infant Patients with migraine headaches Patients taking Coumadin within 7 days or demonstrating INR > 13 Patients taking Heparin unless documented normal partial thromboplastin time Patients taking Clopidogrel in previous 7 days Patients taking Ticlopidine in previous 14 days Patients taking Aspirin in previous 48 hours Patients receiving low molecular weight heparin therapy within 24 hours previous Patients with Narcolepsy and/or sleep apnea Patients on chronic opioid therapy Patients participating in another study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jay Horrow, MD
    Organizational Affiliation
    Drexel University College of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

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