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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Drexel University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00456638
First received: April 4, 2007
Last updated: April 6, 2009
Last verified: April 2008

April 4, 2007
April 6, 2009
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Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
Same as current
Complete list of historical versions of study NCT00456638 on ClinicalTrials.gov Archive Site
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Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain, Postoperative
Drug: Depodur vs. traditional management
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
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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
Both
18 Years and older
No
Contact: Josef Mueksch, MD 215-762-7972 Josef.Mueksch@DrexelMed.edu
United States
 
NCT00456638
16402
No
Josef Mueksch, MD, Drexel University College of Medicine
Drexel University College of Medicine
Not Provided
Study Chair: Jay Horrow, MD Drexel University College of Medicine
Drexel University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP