NCT00456638

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2008

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 15, 2014

Status Verified

April 1, 2008

Enrollment Period

Same day

First QC Date

April 4, 2007

Last Update Submit

August 13, 2014

Conditions

Pain, Postoperative

Keywords

OP-CABGDepodur traditional drug

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Depodur

EXPERIMENTAL

Depodur arm

Drug: Depodur

Traditional

ACTIVE COMPARATOR

traditional management

Drug: Depodur

Interventions

DepodurDRUG

Depodur vs. traditional management

Also known as: Traditional
DepodurTraditional

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female, 18-99 years old
  • All patients who will have surgery for OP-CABG

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jay Horrow, MD

    Drexel University College of Medicine

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

April 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 15, 2014

Record last verified: 2008-04