Trial document




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  DRKS00003494

Trial Description

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Title

Dislocation rates of perineural catheters: a volunteer study

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Trial Acronym

Catheterdislocation study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

20 healthy, male volunteers, aged between 18 and 45 years are enrolled and get two different catheters.
Nerve catheters in clnical practice are needed for sufficient analgesia. Especially after big operations like othopedic surgery patients suffer from pain for a longer time. But an early mobilizsation and rehabilitation is very necessary for a good outcome without a lack of mobilisation. A catheter has its effect in the operation field and not a systemic effect.
But a catheter can shift and then it is infussicient and must be removed. The dislocation rate is evaluated.
After local anaeshesia the catheters are placed under direct vizualisation with ultrasound in the thigh area and in the cervical area.
Saline can be administered through these catheters to control the right position. It is not necesarry for the study that volunteers are administered "real" drugs. Saline can be used for ultrasound because of the same echogenity, the look the same.
Three times hourly volunteers have to practise standardized examinations. After that they should move in a, "every day way" (e.g. walking, eating)
Periodic saline application and ultrasound examination should clarify if the catheters are dislocated or not.
After 300 minutes the active part of the study day is finished.
The dislocation rate should be evaluated.

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Brief Summary in Scientific Language

It is an open, uncontrolled, prospective volunteers study with 20 healthy males.
After local anaesthesia two different catheters (femoralis catheter and scalaenuscatheter) are placed under direct vizualisation with ultrasound in the thigh area and in the cervical area. Saline can be administered via these catheters to illustrate the expansion.
For three times the volunteers have to undergo standardized examinations hourly. Thereafter subjects are allowed approximate 2 hours of unstandardized movements including walking, food intake etc.
In regular intervals the catheters localisation are controlled by ultrasound: saline around the nerve is associated with correct postion. Male distributation of saline around the nerve (i.e. no contact betweens saline and nerve surface) is associated with dislocation.
After 300 minutes the active part of the study day is finished. The dislocation rate should be evaluated.

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Organizational Data

  •   DRKS00003494
  •   2012/11/13
  •   [---]*
  •   yes
  •   Approved
  •   1121/2011, Ethikkommission der Medizinischen Universität Wien
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Secondary IDs

  •   2011-005530-19 
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Health Condition or Problem studied

  •   Healthy participants
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Interventions/Observational Groups

  •   20 male, healthy volunteers get a femoral nerve catheter and a scalaenus catheter and have to practice standardized movements intermittently.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Two different nerve catheters are located with the help of ultrasound.
Each volunteer has to perform physiotherapeutic exercises hourly all together for 3 times. After these exercises the volunteer has to undergo an ultrasound examination to evaluate catheter postion.
After 3 runs volunteers should do daily routine activities for 2hours.
After this procedure a final ultrasound examination take place.
The dislocation rate are evaluated.


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Secondary Outcome

no secondary outcome

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/11/04
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

•Healthy males aged between 18 and 45 years
•BMI < 30 kg/m2
•Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
•No legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study

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Exclusion Criteria

•Anatomical abnormalities of the upper or lower limbs
•BMI >30 kg/m2
•Use of NSAID during the last 2 weeks
•Known allergy or hypersensitivity against mepivacaine or amino-amide local anaesthetics
•Participation in another clinical study within the last 4 weeks prior to study
•Coagulopathy
•Abnormalities in ECG that are considered clinically relevant like AV-block or bradykardia
•Unreliability and/or lack of cooperation
•Inability to perform the standardized physical exercises (definition see below)
•Other objections to participate in the study in the opinion of the investigator

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Addresses

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    • Universitätsklinik für Klinische Pharmakologie
    • Mr.  Univ.-Prof.Dr.  Markus  Müller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Medizinische Universität Wien, Universtitäsklinik Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Daniela  Marhofer 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Daniela  Marhofer 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
    • Mr.  Univ.-Prof.Dr.  Markus  Müller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/19
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.