NCT00408044

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

2 months

First QC Date

December 4, 2006

Last Update Submit

May 19, 2008

Conditions

Ischemic CardiopathyOther Forms of Cardiopathy

Interventions

cardiac surgery with sternotomyPROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac surgery with sternotomy

You may not qualify if:

  • patients with chronic pain
  • redo surgery
  • patients with neurological pathologies
  • patients treated with antidepressant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Cardiac Surgical ProceduresSternotomy

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Mona Momeni, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

BE(1)