Trial document




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  DRKS00011585

Trial Description

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Title

Comparative study for ultrasound guided placement of femoral nerve katheters in out-of-plane versus in-plane technique, in patients with femoral neck frakture.

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Trial Acronym

NFK

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URL of the Trial

http://.

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

In this Study we aim to compare two techniques of ultrasound guided femoral nerve catheter placement in patients with proximal femoral fracture. The techniques differ in the positioning of the ultrasound- transducer in relation to the positioning of the needle (In- and Out of Plane).
Both methods are well established in the clinical routine.
After randomization Patients will receive either an "In plane" or an "Out of Plane" catheter before undergoing hip surgery. The positioning of the catheter will be verified using ultrasound during the procedure and 2 days after surgery in the postoperative X-ray imaging of the hip.
Using the visual data we try to correlate the effectiveness in pain management, paresthesia and postoperative process with the position of the catheter. The quality and the postoperative pain therapy will be evaluated using the Quips-chart on day one and two after surgery.

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Organizational Data

  •   DRKS00011585
  •   2017/01/18
  •   [---]*
  •   yes
  •   Approved
  •   11/5/14, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   S72.0 -  Fracture of neck of femur
  •   S72.1 -  Pertrochanteric fracture
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Interventions/Observational Groups

  •   20 patients will receive an "in plane" catheter. Pre- and postoperative the pain level and additional need for pain medication will be monitored. Via Ultrasound and X-ray technology the positioning of the Catheter will be described.
  •   20 patients will receive an "in plane" catheter. Pre- and postoperative the pain level and additional need for pain medication will be monitored. Via Ultrasound and X-ray technology the positioning of the Catheter will be described.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

The postoperative pain level and the degree of paraesthesia will be measured bevore as well as the first and second day after surgery (Using the Quips Chart).

Ultrasoundcontrolled determination of the catheter position will be performed during the procedure.

The postoperative X-ray of the hip will be done on the second postoperative day

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Secondary Outcome

Further Data will be collected on the first two days after surgery including: Duration of usage of the catheter, degree of strength in the limb (Janda Score), sings of neural damage, sings of infection, disconnection, degree of mobilization, additional usage of analgesics.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

We will include 40 patients undergoing hip surgery.
Patients will be randomized in to two groups with 20 patients receiving a femoral nerve catheter in "in plane" and 20 in "out of plane" technique.
Patients will be included after elucidation and consent to the procedure and the clinical trial.

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Exclusion Criteria

No consent, neural damage in the femoral region,
infection in the region, polyneuropathy, muscle- and nerve- disease, known allergy to local anesthetics.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin Göttingen
    • Mr.  Apl. Prof. Dr. med.  Ingo  Bergmann 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Mr.  Apl. Prof. Dr. med.  Ingo  Bergmann 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Mr.  Apl. Prof. Dr. med.  Ingo  Bergmann 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/01
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Trial Publications, Results and other Documents

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