Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

NCT ID: NCT01402778

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dislocation Infection Line Colonisation Line Insertion Site

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cather fixation by tunneling and suture

No interventions assigned to this group

Catheter fixation by adhesive tape

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients aged \> 18 years and operation with thoracic epidural

Exclusion Criteria

Refusal of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Osnabrueck

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Anästhesiologie

Prof. Dr. Peter Kienbaum

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Kienbaum, Professor

Role: PRINCIPAL_INVESTIGATOR

Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. Pannen

Martin Beiderlinden, Privatdozent

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, Marienhospital Osnabrueck

Locations

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Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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02-VBTSPK-2011

Identifier Type: -

Identifier Source: org_study_id