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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402778
Other study ID # 02-VBTSPK-2011
Secondary ID
Status Completed
Phase N/A
First received January 12, 2011
Last updated December 19, 2011
Start date January 2011
Est. completion date December 2011

Study information

Verified date December 2011
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients aged > 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology Duesseldorf NRW

Sponsors (2)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf University of Osnabrueck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in catheter position Difference in catheter position between day of insertion and day of removal, measured in mm between catheter tip and skin niveau 4-6 days No
Secondary Secondary variables Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal 4-6 days Yes
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