Trial document





This trial has been registered retrospectively.
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  DRKS00003632

Trial Description

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Title

Influence of different positioning of a local pain catheter on pain perception after paramedian extraperitoneal laparotomy for radical iliacal lymphadenectomy. A randomised controlled trial.

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Trial Acronym

ILKA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this trial is to examine if the position of a local pain catheter has an influence on postoperative pain after radical iliac lymph node dissection.
Therefore the patients have been randomized in two groups. Group A gets a subfascial pain catheter while Group B gets an subcutanious pain catheter at the end of the operation.
Every patient records the postoperative pain in a pain diary using the visual analog scale.
Based on this data and the additional need of systemic analgesia the efficacy of the localisation of the pain catheter will be examined

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Brief Summary in Scientific Language

In this prospective randomized, double blinded controlled trial the aim is to examine if the position of a local pain catheter has an influence on postoperative pain after radical iliac lymph node dissection.
Therefore the patients have been randomized in two groups. Group A gets a subfascial pain catheter while Group B gets an subcutanious pain catheter at the end of the operation.
Every patient records the postoperative pain in a pain diary using the visual analog scale.
Based on this data and the additional need of systemic analgesia the efficacy of the localisation of the pain catheter will be examined

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Organizational Data

  •   DRKS00003632
  •   2014/12/17
  •   [---]*
  •   yes
  •   Approved
  •   EA 1/212/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   C43 -  Malignant melanoma of skin
  •   C77 -  Secondary and unspecified malignant neoplasm of lymph nodes
  •   R52.9 -  Pain, unspecified
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Interventions/Observational Groups

  •   subcutanious pain katheter
  •   subfascial pain katheter
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

pain on the first postoperative day and the pain over the course of the postoperative hospital stay, measured by visual analog scale

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Secondary Outcome

satisfaction with analgetic treatment measured by visual analog scale on first day after operation and during the hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/01/31
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

medical indication to perform radical lymph node dissection in patients with lymph node metastasis of malignant melanoma

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Exclusion Criteria

allergy against local anasthesia, chronic pain syndrom, occured operation in the same region

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Addresses

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    • Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Universitätsmedizin Berlin, Campus Mitte
    • 10117  Berlin
    • Germany
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    • Klinik für Allgemein-, Viszeral-, Gefäß- und ThoraxchirurgieCharité Universitätsmedizin Berlin, Campus Mitte
    • Mr.  Martin  Schomaker 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Allgemein-, Viszeral-, Gefäß- und ThoraxchirurgieCharité Universitätsmedizin Berlin, Campus Mitte
    • Mr.  Martin  Schomaker 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Universitätsmedizin Berlin, Campus Mitte
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/20
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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.