Text Size

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
History of Changes
  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 vs. traditional management

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:

U.S. FDA Resources

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

Estimated Enrollment: 50
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456638

Contacts
Contact: Josef Mueksch, MD 215-762-7972 Josef.Mueksch@DrexelMed.edu

Locations
United States, Pennsylvania
Hahnemann University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Josef Mueksch, MD     215-762-7972     Josef.Mueksch@DrexelMed.edu    
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: Josef Mueksch, MD, 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: April 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Patients who will have surgery for OP-CABG
The focus of the study is to rule out efficacy of the drug Depodur in comparison to traditional drug

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

ClinicalTrials.gov processed this record on May 22, 2013