Dysesthesia Study After Sternotomy

Ischemic Cardiopathy Clinical Trial

Official title:

Pain After Sternotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408044
• Other study ID #: CE 2005/05SEPT/134
• Status: Completed
• Phase: N/A
• First received: December 4, 2006
• Last updated: May 19, 2008
• Start date: December 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2008
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Cardiac surgery with sternotomy

Exclusion Criteria:

• patients with chronic pain

• redo surgery

• patients with neurological pathologies

• patients treated with antidepressant medication

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Diseases
• Ischemic Cardiopathy
• Other Forms of Cardiopathy

Intervention

Procedure:
• cardiac surgery with sternotomy

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium,