Trial document





This trial has been registered retrospectively.
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  DRKS00018812

Trial Description

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Title

Comparability of the lateral versus the anterior approaches to block of the sciatic nerve, each in combination with a femoral nerve block.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study compares two regional anaesthesia techniques for pain Management after total knee anrthroplasty. The continous Blockade of the femoral nerve in combination with the Blockade of the sciatic nerve is effective in pain therapy. That is what we know, but it is unclear where exactly to block the nerves in their anatomical course. Many aspects Play a role by choosing the best approaches to the nerve, e.g. best anaesthetization with moderate side effects, handling in daily Routine without time delay. We are comparing the continous Blockade of the femoral nerve (inguinal Approach) either in combination with a distal-lateral Approach to block the sciatic nerve or in combination with an proximal-anterior Approach to block the sciatic nerve. We Postulate a difference between these two techniques in pain effectiveness. We investigate adult persons with total knee arthroplasty.

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Brief Summary in Scientific Language

Background: Pain Management after total knee arthroplasty is still challenging. To date a Gold Standard is not implemented. In daily Routine Systemic application of Opioids and non-Opioids are widely-used with or without a combination of peripheral nerve blocks. A (continous) femoral nerve block in combination with a (continous) sciatic nerve block seems to be superior to other regional anaesthesia techniques. Up to now there is an accordance to block the femoral nerve via an inguinal Approach, but dissension exist about the "best" Approach to sciatic nerve block. On the one Hand the Approach should be easily performed without changing patients Position and on the other Hand it should cause best analgesia without muscular weakness. Sciatic nerve block is mostly perfomed via a proximal -anterior Approach (technique described by Beck or Meier) although this technique is sometimes difficult and time-consuming. Therefore we intend to compare two different approaches to sciatic nerve, each in combination with a femoral nerve block for pain Management after total knee arthroplasty. To date there is no Research about two different approaches to sciatic nerve in a catheter based technique. Hence we will exclusively use continous techniques. The catheters will be in place until day three after surgery.
Hypothesis: A continous Blockade of sciatic nerve via distal-lateral Approach is different in pain effectiveness to a Blockade of sciatic nerve via proximal-anterior Approach, each in combination with a continous Blockade of the femoral nerve.
Its main aim is the postoperative quality of pain management after total knee arthroplasty. Therefore we quantify the cumulative opiod cosumption after 48 hours.
Secondary objetives are patients assessment of pain therapy with the help of numeric rating scale, patients satisfaction, time requirement to perform peripheral nerve blocks, muscular weakness and grade of inflection (knee joint).
Study design: In this randomised, prospective study we will generate two groups of patients, who underwent total knee arthroplasty in our hospital. Patients in the standard group get a combination of a continous blockade of femoral nerve (inguinal approach) and a continous blockade of sciatic nerve via the proximal-anterior approach.
Patients of the intervention group get a combination of a continous blockade of femoral nerve (inguinal approach) an a continous blockade of sciatic nerve via the distal-lateral approach.
The peripheral nerve blocks will be performed by a study physician after induction of general anaesthesia. The prozedure is stadardized and we are using ultrasonography and nerve stimulation (dual guidance). We will measure the time need to perform the catheter techniques in both groups.
When the surgery is finished we will inject permanently a defined application rate of local anaesthetic (LA) via the catheters. The LA and the application rate is identic for every patient in both groups. Patients in both groups receive analgesic drugs in addition to their regional anaesthesia (acetaminophen or metamizole) and a patient controlled analgesia (PCA with Piritramid).
All patients will be interviewed on day one an two after surgery by medical staff to evaluate quality of pain management. For this purpose we will note pain intensity at rest and on movement via numeric rating scale and we will note Piritramid consumption. Moreover we will register movement in knee joint and possible side effects.
Overall we aim to include 46 patients in this study. The time period will be about one year.

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Organizational Data

  •   DRKS00018812
  •   2019/10/09
  •   [---]*
  •   yes
  •   Approved
  •   FF 28/2019, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
  •   M17.0 -  Primary gonarthrosis, bilateral
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Interventions/Observational Groups

  •   Continous blockade of the femoral nerve (inguinal approach) in combination with a continous blockadde of the sciatic nerve (proximal-anterior approach)
  •   Continous blockade of the femoral nerve (inguinal approach) in combination with a continous blockade of the sciatic nerve (distal lateral approach)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Quality of pain therapie. Patients interview about pain intensity (numeric ratin scale) and measurement of the cumulative oopioid consumption

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Secondary Outcome

Time needed to perform regional anaeshetic technique, muscular weakness, inflection and streching in knee joint

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/07/26
  •   46
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Adult persons who are undergoing a total knee arthroplasty, able to give a Statement of intent, ASA-Class I-III

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Exclusion Criteria

Intolerance to local anaesthetics, Patient refusal, skin infection at the site of needle insertion, not of full Age, ASA-Class IV-V, pregnancy or lactation, neurologic disease, insufficient knowledge of the german language, lack of cooperation, chronic pain Syndrom with opiops, BMI >35, coagulopathy, inability to give a Statement of intent

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Addresses

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    • Asklepios Klinik LangenAbteilung für Anästhesie und perioperative Medizin
    • Mr.  Michael  Schöffner 
    • Röntgenstr. 20
    • 63225  Langen
    • Germany
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    • Asklepios Klinik LangenAbteilung für Anästhesie und perioperative Medizin
    • Mr.  Michael  Schöffner 
    • Röntgenstr. 20
    • 63225  Langen
    • Germany
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    • Asklepios Klinik LangenAbteilung für Anästhesie und perioperative Medizin
    • Mr.  Michael  Schöffner 
    • Röntgenstr. 20
    • 63225  Langen
    • Germany
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Sources of Monetary or Material Support

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    • Asklepios Klinik LangenAbteilung für Anästhesie und perioperative Medizin
    • Mr.  Michael  Schöffner 
    • Röntgenstr. 20
    • 63225  Langen
    • Germany
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Status

  •   Recruiting ongoing
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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.