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

This study has been withdrawn prior to enrollment.
(Difficulty aquiring investigational drug)
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00456638
First received: April 4, 2007
Last updated: August 13, 2014
Last verified: April 2008

April 4, 2007
August 13, 2014
April 2008
April 2008   (final data collection date for primary outcome measure)
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
Not Provided
Not Provided
Not Provided
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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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain, Postoperative
Drug: Depodur
Depodur vs. traditional management
Other Names:
  • Depodur
  • Traditional
  • Experimental: Depodur
    Depodur arm
    Intervention: Drug: Depodur
  • Active Comparator: Traditional
    traditional management
    Intervention: Drug: Depodur
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2008
April 2008   (final data collection date for primary outcome measure)

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 to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00456638
16402
No
Drexel University ( 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