Trial document




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  DRKS00003869

Trial Description

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Title

Topical EMLA-patch for postoperative wound pain after gynecological laparoscopy

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Trial Acronym

EMGYN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of this study is to analyse the effectivity of anesthtic patches (patches containing anesthetics) on incisional pain after laparoscopic surgery. Patients undergoing surgery due to gynecologic reasons are going to be examined. The priniciple aim of this study is postoperative pain these anesthetic patches compared to conventional patches. Further study aims are the evaluation of the length of hospital stay and need of additional medication for pain relief. Hence either anesthetic patches or conventional patches are installed on the incisions after suergery. The amount of pain after surgery will be analysed with a standardised questionnaire.

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Brief Summary in Scientific Language

Aim of this study is to analyse the effectivity of EMLA-patches on incisional pain after laparoscopic surgery. Patients undergoing surgery due to gynecologic reasons are going to be examined. The priniciple aim of this study is postoperative pain using EMLA-patches compared to conventional patches. Further study endpoints are length of hospital stay and need of additional medication for pain relief. Hence either EMLA-patches or conventional patches are installed on the incisions after suergery. The amount of pain after surgery will be analysed with a standardised questionnaire (Short-Form McGill Pain Questionnaire (MPQ-SF)).

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Organizational Data

  •   DRKS00003869
  •   2012/05/04
  •   [---]*
  •   yes
  •   Approved
  •   2012-252N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   D25.9 -  Leiomyoma of uterus, unspecified
  •   R10.3 -  Pain localized to other parts of lower abdomen
  •   Other gynaecologic diseases in which a laparoscopy has to be performed.
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Interventions/Observational Groups

  •   Study collective: EMLA-patch
  •   Control collective: placebo (conventional patch)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Priniciple aim of this study is postoperative pain using EMLA-patches compared to conventional patches (controlled by the standardized Questionaire"Short form Mc Gill Pain Questionaire").

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Secondary Outcome

Further study endpoints are length of hospital stay and need of additional medication for pain relief.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/05/15
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with laparoscopy

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Exclusion Criteria

allergy against amide-anesthetics

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Mannheim
    • Mr.  Prof. Dr.   Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr.  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Dr.  Amadeus  Hornemann 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Mannheim
    • Mr.  Prof. Dr.   Marc  Sütterlin 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting planned
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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.