Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000197

Trial Description

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Title

Continuous spinal analgesia versus continuous femoral nerve
block for elective total knee replacement.

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Trial Acronym

CSA versus Femoral Nerve Block

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Postoperative Pain Therapy is an important part of perioperative treatment of patients after major operations and there is ample evidence displaying the benefit in postoperative recovery of patients. Several problems that are encountered after big operations can be avoided by providing adequate pain therapy. Mainly these are: Myocardial infarctions, pulmonary complications and thrombosis. Mobilisation of the patient is possible at an earlier stage in the recovery process. There are several possible ways to provide postoperative pain relief after total knee replacement. This study wants to investigate whether a continuous spinal anaesthesia or a femoral nerve block is the preferable method for postoperative pain relief.

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Brief Summary in Scientific Language

Continuous spinal analgesia and continuous femoral nerve blockade are well established procedures for postoperative pain relief. This randomised controlled study compares these two regimens in patients undergoing total knee arthroplasty with the aim to quantify efficacy in pain relief, adverse effects and complications. The data from the PROSPECT study does not involve continuous spinal anaesthesia possibly due to lack of sufficient data. We aim to close the gap in the comparison of the various methods.

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Organizational Data

  •   DRKS00000197
  •   2009/09/08
  •   [---]*
  •   yes
  •   Approved
  •   2007-460-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1111-7490 
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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Continuous Spinal Anaesthesia
    preop induction, perioperative titration of local anaesthetics to desired level, postoperative attachment of catheter to continuous pump delivering bupivacaine 0.35% at 0.4ml/h
  •   Induction of anaesthesia for operation with a single shot spinal anaesthesia, establishment of femoral catheter for postoperative pain therapy. Attachment of catheter to pump delivering Ropivacaine 0.2% at a rate of 8-12 ml/h
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

In the postoperative course we evaluate pain by the application of numeric rating scales (NRS) and visual analogue scales (VAS) as well as opioid consumption to compare the effectiveness of the two methods of postoperative pain control.

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Secondary Outcome

Secondary endpoints are problems and/or complications of the two methods.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/01/05
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

60 yrs or older, ASA I-III, undergoing Total Knee Endoprosthesis, elective case, consent to participate in study

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Exclusion Criteria

Exclusion criteria are inability to give informed consent for language or cognitive reasons, contraindications to spinal anaesthesia or femoral nerve block including patients refusal, platelet count of less than 80 x 109/L or known coagulopathy, infection overlying the injection site, history of chronic pain and contraindications to any study drugs.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • St. Franziskus Hospital Münster Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Prof. Dr. med.  Michael  Möllmann 
    • Hohnezollernring 72
    • 48145  Münster
    • Germany
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    • Universitätsklinik Münster Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr. med.  Daniel  Pöpping 
    • Albert-Schweitzer-Str. 33
    • 48149  Münster
    • Germany
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    • Universitätsklinik Münster Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr. med.  Manuel  Wenk 
    • Albert-Schweitzer-Str. 33
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und operative Intensivmedizin St. Franziskus Hospital Münster
    • Mr.  Prof. Dr. med.  Michael  Möllmann 
    • Hohenzollernring 72
    • 48145  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/09/12
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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.