Trial document




drksid header

  DRKS00005626

Trial Description

start of 1:1-Block title

Title

In-situ-localization of nerve catheters in human cadavers compared to prior ultrasound-guided localization and to distribution of methylen-blue-injection

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PNK-Anatomie

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http:///

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Peripheral nerve catheters are needed for pain therapy. The localization of the nerve with the puncture needle can ultrasound- or stimulation- guided controlled ( by current pulses from the needle ). Both methods are described as a standard procedure in anesthesia . In the " original " nerve - controlled process, the puncture site is alone selected to landmarks technology and selected the optimal needle - nerve distance by varying degrees of nerve stimulation and thus caused motor optimal stimulation response ( movement of muscles ).
After "blind" injection of a local anesthetic depots via the puncture needle, the catheter is several centimeters (usually ≥ 3 to 5 cm) above the needle still lying also "blind" advanced. This is done in the idea that the previously injected local anesthetic depot strictly expands along the nerve course and the catheter creates along the nerve. With the help of ultrasound can not only peripheral nerves but also sparing neighboring structures as clearly visualize how the position of the needle tip and especially the injected local anesthetic. After the local anesthetic depot is applied to the nerve, the nerve catheter is then advanced alike about the end of the puncture needle ≥ 3 to 5 cm out to the nerves. However, sonographic visualization of nerve catheter itself and in particular its tip is not certainly possible. This is due to the mostly non coplanar catheter course, lack of ultrasonic reflection of the catheter ends and the lack of visualization option, depending on the tissue depth at which the nerve to be anesthetized is localized. A recent study has up to 25% by catheter malposition and hereby underlines the clinical relevance of this problem. While intraoperatively and postoperatively for several hours still affects the sonographically controlled applied local anesthetic depot analgesic, is especially during the first postoperative days, the location of the catheter tip, and thus the distribution of the now continuously through the catheter applied local anesthetic.
For localization of the nerve catheter may procedures are available that show the position of the catheter tip by injection of fluid, air or shake local anesthetic and the outlet at the nerve catheter tip after conventional conditioning method. Most practical injecting additional local anesthetic is likely to be, whose turbulence could make them visible after leaving the catheter tip in the color-doppler ultrasound.
The aim of this study it shall be to carry out a position control of the nerve catheter at body donors and to compare them with the previously performed doppler ultrasound technique, and ultrasound to compare art to the blind advancing the nerve catheter in relation to the distribution of a dye.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Peripheral nerve catheters are needed for pain therapy. The localization of the nerve with the puncture needle can ultrasound- or stimulation- guided controlled. Both methods are described as a standard procedure in anesthesia . In the " original " nerve - controlled process, the puncture site is alone selected to landmarks technology and selected the optimal needle - nerve distance by varying degrees of nerve stimulation and thus caused motor optimal stimulation response.
After "blind" injection of a local anesthetic depots via the puncture needle, the catheter is several centimeters (usually ≥ 3 to 5 cm) above the needle still lying also "blind" advanced. This is done in the idea that the previously injected local anesthetic depot strictly expands along the nerve course and the catheter creates along the nerve. With the help of ultrasound can not only peripheral nerves but also sparing neighboring structures as clearly visualize how the position of the needle tip and especially the injected local anesthetic. After the local anesthetic depot is applied to the nerve, the nerve catheter is then advanced alike about the end of the puncture needle ≥ 3 to 5 cm out to the nerves. However, sonographic visualization of nerve catheter itself and in particular its tip is not certainly possible. This is due to the mostly non coplanar catheter course, lack of ultrasonic reflection of the catheter ends and the lack of visualization option, depending on the tissue depth at which the nerve to be anesthetized is localized. A recent study has up to 25% by catheter malposition and hereby underlines the clinical relevance of this problem. While intraoperatively and postoperatively for several hours still affects the sonographically controlled applied local anesthetic depot analgesic, is especially during the first postoperative days, the location of the catheter tip, and thus the distribution of the now continuously through the catheter applied local anesthetic.
For localization of the nerve catheter may procedures are available that show the position of the catheter tip by injection of fluid, air or shake local anesthetic and the outlet at the nerve catheter tip after conventional conditioning method. Most practical injecting additional local anesthetic is likely to be, whose turbulence could make them visible after leaving the catheter tip in the color-doppler ultrasound.
The aim of this study it shall be to carry out a position control of the nerve catheter at body donors and to compare them with the previously performed doppler ultrasound technique, and ultrasound to compare art to the blind advancing the nerve catheter in relation to the distribution of Methylenblue.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005626
  •   2015/07/10
  •   [---]*
  •   yes
  •   Approved
  •   9/7/2013 Amendement, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   [---]* 
  •   [---]* 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S42 -  Fracture of shoulder and upper arm
  •   M24 -  Other specific joint derangements
  •   Puncture of peripheral nerve catheters
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Sonographically guided controlled of peripheral nerve catheters for body donors . Randomization of the process :
    Conditioning blind 3-5 cm above the puncture needle and correlation of the in situ position of the catheter tip after dissection with the previously sonographically guided by color Doppler shift control procedures
  •   Sonographically guided controlled of peripheral nerve catheters for body donors . Randomization of the process :
    Sonographically guided by color Doppler shift and correlation of the in situ position of the catheter tip after dissection.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Comparison of the Doppler-shift-method for determining the catheter tip position after ultrasound-guided placement of peripheral nerve catheter with the actual location of the catheter tip in situ after dissection of the nerve catheter

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Spatial distribution of the injected via a ultrasound-guided placed peripheral nerve catheter methylene blue

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/08/01
  •   5
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- existence of the legacy for body donation in the anatomical institute of the Universitätsmedizin Göttingen signed by the donor during his lifetime
- release of body donation by medical officer

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

none

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin Göttingen Klinik für Anästhesiolgie Zentrum Anästhesiologie, Rettungs- und Intensivmedizin Robert-Koch Str. 40 37075 Göttingen
    • Mr.  Dr. med  Ingo  Bergmann 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsmedizin GöttingenZentrum für Anatomie
    • Kreuzbergring 36
    • 37075  Göttingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin Göttingen Klinik für Anästhesiolgie Zentrum Anästhesiologie, Rettungs- und Intensivmedizin Robert-Koch Str. 40 37075 Göttingen
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin GöttingenKlinik für Anästhesiologie
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Kochstr. 40
    • 37075  Göttingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.