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

Drexel University College of Medicine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Conditions

Pain, Postoperative

Interventions

DepodurDRUG

Depodur vs. traditional management

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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