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

Not Applicable

Withdrawn

• Conditions: Pain, Postoperative
• Interventions: Drug: Depodur

• Registration Number: NCT00456638
• Lead Sponsor: Drexel University College of Medicine

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

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.

Study Timeline

• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-05
• Status Verified: 2008-04
• Study Start: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Depodur	traditional management
Depodur	Depodur	Depodur arm

Primary Outcome Measures

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