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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Pain, Postoperative
Drug: Depodur

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)

Resource links provided by NLM:


Further study details as provided by Drexel University:

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

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depodur
Depodur arm
Drug: Depodur
Depodur vs. traditional management
Other Names:
  • Depodur
  • Traditional
Active Comparator: Traditional
traditional management
Drug: Depodur
Depodur vs. traditional management
Other Names:
  • Depodur
  • Traditional

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456638

Sponsors and Collaborators
Drexel University College of Medicine
Investigators
Study Chair: Jay Horrow, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00456638     History of Changes
Other Study ID Numbers: 16402
Study First Received: April 4, 2007
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
OP-CABG
Depodur traditional drug

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014