Pain, Postoperative
Conditions
Keywords
OP-CABG, Depodur traditional drug
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.
Interventions
DRUGDepodur
Depodur vs. traditional management
Sponsors
Drexel University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups | — |
Outcome results
None listed