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

This study is not yet open for participant recruitment.

Verified by Drexel University, April 2008

First Received: April 4, 2007 Last Updated: April 6, 2009 History of Changes

Sponsor:	Drexel University College of Medicine
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00456638

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:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
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:

MedlinePlus related topics: Coronary Artery Bypass Surgery Surgery

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:

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
Philadelphia, Pennsylvania, United States, 19102

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 College of Medicine ( Josef Mueksch, MD )
Study ID Numbers:	16402
Study First Received:	April 4, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00456638 History of Changes
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:

Morphine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010