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Dysesthesia Study After Sternotomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408044
First Posted: December 5, 2006
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose

Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.

33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year.

This pain has often negative effects on daily activity. Despite its frequency and importance, the etiology of this chronic pain is not completely understood.

The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or to treat better in the future.

The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which can be observed within several weeks. Therefore we decided to study this evolution.

This study is different from previous ones observing the sensitivity of the thorax at a well defined moment immediately after the surgery.


Condition Intervention
Ischemic Cardiopathy Other Forms of Cardiopathy Procedure: cardiac surgery with sternotomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pain After Sternotomy

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac surgery with sternotomy

Exclusion Criteria:

  • patients with chronic pain
  • redo surgery
  • patients with neurological pathologies
  • patients treated with antidepressant medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408044


Locations
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Mona Momeni, MD Cliniques universitaires Saint-Luc
  More Information

Responsible Party: Mona Momeni, Cliniques Universitaires Saint Luc
ClinicalTrials.gov Identifier: NCT00408044     History of Changes
Other Study ID Numbers: CE 2005/05SEPT/134
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: May 20, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases