Trial document





This trial has been registered retrospectively.
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  DRKS00004537

Trial Description

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Title

Ultrasound-guided peripheral nerve blocks in combination with general anesthesia on an outpatient basis, in terms of processing time, hemodynamic stability, complications, postoperative pain, and sympathetic activity compared to general anesthesia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

It will examine how the use of ultrasound-controlled peripheral nerve blockade in combination with a general anesthesia(combined anesthesia) compared to standard techniques (general anesthesia) in outpatient anesthesia effect. The hypothesis is that with a combination of anesthesia, the patient requires less general anesthesia and therefore fewer side effects such as nausea, vomiting and pain will have surgery, and a hemodynamically stabiliere anesthesia. Furthermore, the combination of anesthesia could produce significantly shorter process times. Included are ambulatory patients requiring a arthroskopy of a joint and be operated on an outpatient basis.

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Brief Summary in Scientific Language

Comparison of combined anesthesia (general anesthesia with peripheral nerve blocks) with general anesthesia on an outpatient basis. The peripheral nerve block is a low-volume, single-shot method. Hypothesis that the combination provides a greater anesthetic intraoperative hemodynamic stability, and shorter is change times, since Complications in the recovery room to be reduced. It examines patients receiving outpatient arthroscopy.
Randomization over the day of week.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004537
  •   2013/03/25
  •   [---]*
  •   yes
  •   Approved
  •   9/8/11, 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

  •   General anesthesia for Knee arthroscopy surgery
  •   General anesthesia for Shoulder arthroscopy surgery
  •   M23 -  Internal derangement of knee
  •   M75.4 -  Impingement syndrome of shoulder
  •   M19.07 -  [generalization M19.0: Primary arthrosis of other joints]
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Interventions/Observational Groups

  •   Study Group: Creation of a low volume (10 ml ropivacaine 2%) sonographic präopertiv, subsequent general anesthesia
  •   Standard procedures / controls: general anesthesia without peripheral nerve blockade
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

incidence and severity of postoperative pain, and time spent in recovery room - telephone interview on PACU and 2 postoperative days

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Secondary Outcome

total anesthesia time and postoperative complications - recovery survey, documentation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/06/15
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients who are to be operated on electively outpatient arthroscopy of the knee Joint, ankle Joint or the shoulder joint.

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Exclusion Criteria

Pre-existing nerve damage
polyneuropathy
Infection in the field of nerve block
Allergy to local anesthetics
Muscle or nerve disorders

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Addresses

  • start of 1:1-Block address primary-sponsor
    • UMG Göttingen
    • Mr.  Dr. med  Ingo  Bergmann 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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    • UMG Göttingen
    • Mr.  Dr. med  Ingo  Bergmann 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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    • UMG Göttingen
    • Mr.  Dr. med  Ingo  Bergmann 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/31
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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.