Trial document




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  DRKS00003255

Trial Description

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Title

Electrical nerve stimulation threshold of the sciatic nerve in diabetic patients with ischemic gangrene of the foot. A comparison with nondiabetic patients undergoing orthopedic surgery

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Surgery of the food or lower leg is frequently performed under regional anesthesia of the sciatic nerve. Electrical nerve stimulation which creates a contraction of muscles is an accepted method for nerve localization when performing regional anesthesia. This study has been designed to test the hypothesis that the method of electrical nerve stimulation does not work reliably in diabetic patients compared to nondiabetic patients.

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Brief Summary in Scientific Language

The purpose of this study is to test the hypothesis that the threshold current required to elicit a motor response of the sciatic nerve is markedly increased in diabetic patients who are scheduled for foot surgery or minor amputation due to diabetic gangrene compared to a nondiabetic patient group. If the hypothesis is correct, electrical nerve stimulation would be of limited value for localizing nerves when performing regional anesthesia.

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Organizational Data

  •   DRKS00003255
  •   2011/09/09
  •   [---]*
  •   yes
  •   Approved
  •   275/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   E14.5 -  Unspecified diabetes mellitus; With peripheral circulatory complications
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Diabetic patients scheduled for foot surgery or minor amputation for diabetic gangrene
  •   nondiabetic patients scheduled for orthopedic surgery of the foot or lower leg
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
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Primary Outcome

Threshold of the stimulating current at needle-to-epineurium contact during performance of ultrasound-guided sciatic nerve block. The threshold is defined a minimal current which is required to elicit a motor response at a pulse width of 0.1 ms and a stimulation frequency of 1 Hz.

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Secondary Outcome

Maximum distance between needle tip and sciatic nerve for eliciting a motor response at a pulse width of 0.1 ms, a stimulation frequenvy of 1 Hz, and a current of 1 mA and 0.5 mA, respectively, during ulrasound-guided block of the sciatic nerve.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/09/08
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Diabetic patients
- Diabetes mellitus
- patients scheduled for foot surgery or minor amputation for diabetic gangrene
- aged over 50 years
- written informed consent

control group
- patients scheduled for orthopedic foot- or lower leg surgery
- aged over 50 years
- written informed consent

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Exclusion Criteria

diabetic patients
- contraindications to ischiadic nerve block
- central nervous system disease, peripheral nerve disease or neuromuscular disease except for diabetic neuropathy
- missing written informed consent

control group
- contraindications to ischiadic nerve block
- central nervous system disease, peripheral nerve disease, neuromuscular disease
- Diabetes mellitus
- end stage renal disease
- missing written informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Herz-Zentrum Bad Krozingen
    • Mr.  Prof. Dr.   Cornelius  Keyl 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Abteilung für Anästhesie, Universitäts-Herz-Zentrum Freiburg-Bad Krozingen
    • Mr.  Prof. Dr.   Cornelius  Keyl 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
    • Mr.  Prof. Dr.   Cornelius  Keyl 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Sources of Monetary or Material Support

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    • Herz-Zentrum Bad Krozingen
    • 79189  Bad Krozingen
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/07/15
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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.