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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00456638
• Other study ID #: 16402
• Status: Withdrawn
• Phase: N/A
• First received: April 4, 2007
• Last updated: August 13, 2014
• Start date: April 2008
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Depodur
Depodur vs. traditional management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups