Dysesthesia Study After Sternotomy
| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2006 | ||||
| Last Updated Date | May 19, 2008 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00408044 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dysesthesia Study After Sternotomy | ||||
| Official Title ICMJE | Pain After Sternotomy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: cardiac surgery with sternotomy | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00408044 | ||||
| Other Study ID Numbers ICMJE | CE 2005/05SEPT/134 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Mona Momeni, Cliniques Universitaires Saint Luc | ||||
| Study Sponsor ICMJE | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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