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

Tracking Information

First Received Date ^ICMJE

April 4, 2007

Last Updated Date

April 6, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00456638 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Pain, Postoperative

Intervention ^ICMJE

Drug: Depodur vs. traditional management

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Josef Mueksch, MD

215-762-7972

Josef.Mueksch@DrexelMed.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00456638

Other Study ID Numbers ^ICMJE

16402

Has Data Monitoring Committee

Responsible Party

Josef Mueksch, MD, Drexel University College of Medicine

Study Sponsor ^ICMJE

Drexel University College of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jay Horrow, MD

Drexel University College of Medicine

Information Provided By

Drexel University

Verification Date

April 2008

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

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