Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
Information source: Drexel University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Depodur vs. traditional management (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Drexel University College of Medicine Official(s) and/or principal investigator(s):
Jay Horrow, MD, Study Chair, Affiliation: Drexel University College of Medicine
Overall contact:
Josef Mueksch, MD, Phone: 215-762-7972, Email: Josef.Mueksch@DrexelMed.edu
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.
Clinical Details
Official title: Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Primary outcome: Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Josef Mueksch, MD, Phone: 215-762-7972, Email: Josef.Mueksch@DrexelMed.edu
Hahnemann University Hospital, Philadelphia, Pennsylvania 19102, United States
Additional Information
Last updated: April 6, 2009
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