Dysesthesia Study After Sternotomy | NCT00408044

Studies
Dysesthesia Study After Sternotomy

NCT00408044

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Ischemic Cardiopathy
Other Forms of Cardiopathy

Interventions

cardiac surgery with sternotomy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Feb 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 4, 2006

First Submission Date that Met QC Criteria

Dec 4, 2006

First Posted Date

Dec 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2008

Last Update Posted Date

May 20, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
cardiac surgery with sternotomy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiac surgery with sternotomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mona Momeni, MD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc		Brussels		1200	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures
D056346	Sternotomy

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided