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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Depodur

Depodur arm

Group Type EXPERIMENTAL

Depodur

Intervention Type DRUG

Depodur vs. traditional management

Traditional

traditional management

Group Type ACTIVE_COMPARATOR

Depodur

Intervention Type DRUG

Depodur vs. traditional management

Interventions

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Depodur

Depodur vs. traditional management

Intervention Type DRUG

Other Intervention Names

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Traditional

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No