Trial document




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  DRKS00006037

Trial Description

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Title

Ultrasound Guidance for Axillary Plexus Regional Anesthesia

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Trial Acronym

AxPlex

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Prospective, randomized trial investigating the application of guidance system supported ultrasound imaging during axillary plexus regional anesthesia in hand- and arm surgery. Based on Randomization, subjects will either receive an axillary block using an ultrasound guidance system ( SonixTouchGPS) or using conventional ultrasound in the control group. Primary endpoint will be the subjects pain grading during the axillary block procedure.

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Brief Summary in Scientific Language

This prospective, randomized trial investigates the clinical application of a navigated ultrasound system in the setting of axillary plexus blockade. The ultrasound system in this trial (UltraSonixTouchGPS) allows the visualization of the plexus-needle in relationship to the ultrasound probe by localization of needle and probe in an electromagnetic field. According to randomization, subjects will either receie an axillary block using the navigational spport or using conventional ultrasound alone in the control group. End point will be the percieved pain level of the subject during the axillary block procedure.

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Organizational Data

  •   DRKS00006037
  •   2014/03/29
  •   [---]*
  •   yes
  •   Approved
  •   12-127, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   axillary plexus regional anesthesia
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Interventions/Observational Groups

  •   axillary plexus block - navigation assisted ultrasound
  •   axillary plexus block - conventional ultrasound
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Percieved pain measured on a numeric rating scale from 0(no pain) to 100(maximum pain), recorded directly after completion of axillary plexus block

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Secondary Outcome

Time intervall between axillary block application and establishment of adequate anesthesia allowing surgical therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/04/14
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with planned Hand-forarm surgery

Age>18 years

ASA classification I, II and III

Bodyweight 50-120kg

Written informed consent for study participation / informed consent for regional anesthesia

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Exclusion Criteria

Age < 18 Years

No Informed Consent for study participation / regional anesthesia

inflammation in the planned puncture site for regional anesthesia

pregnancy

Patients that, due to prior medical conditions, did not receive anesthesiologic clearance for surgical therapy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik KölnKlinik für Anästhesie und Operative Intensivmedizin
    • Mr.  Dr. med.  Jochen  Hinkelbein 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    •   02214786283
    •   [---]*
    •   [---]*
    •   [---]*
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    • Uniklinik KölnKlinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Volker  Schick 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik KölnKlinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Volker  Schick 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Uniklinik KölnKlinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Robert  Schier 
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.