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Dysesthesia Study After Sternotomy

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00408044
First received: December 4, 2006
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mona Momeni, Cliniques Universitaires Saint Luc
ClinicalTrials.gov Identifier: NCT00408044     History of Changes
Other Study ID Numbers: CE 2005/05SEPT/134
Study First Received: December 4, 2006
Last Updated: May 19, 2008
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013