Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000752

Trial Description

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Title

Impact of a sigle shot femoralis block on postoperative lung function and haemodynamic stability

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Regional anesthesia for abdominal surgery proofed to be an efective approch to improve postoperative lung function. Apart from thorakoabdominal surgery this effect is yet proofed. Especially pain could contribute to low tidal ventilation. Additionally possible interactions of an increased postoperative opioid consumption may have detrimental effects too. Thus we wanted to evaluate supplemental regional anesthesia for hip surgery and the impact of pain response on postoperative lung function and haemodynamic stability

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Brief Summary in Scientific Language

Supllemantal single shot regional anesthesia for hip surgery an their impact on pain relief in terms of postoperative lung function and haemodynamic stability

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Organizational Data

  •   DRKS00000752
  •   2011/03/30
  •   [---]*
  •   yes
  •   Approved
  •   163/08, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   ppostoperative cardiopulmonary impairment
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Interventions/Observational Groups

  •   Supplemental single shot regional anesthesia using Carbostesin 0.25% + Clonidine 20µg. General anesthesia was performed according to SOP (Standard operating procedure)
  •   Standard therapy (General anesthesia) accord to the respective SOP (standard operating procedure), no additional regional anesthesia was performed.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

lung function within the first 24 postoperative hours at fixed time points: T0h after achieving a modified fast track score >10 (White et al), T1h = 1h post-OP, T2h= 2h post OP, T6h= 6 h post-op, T24h = 24hours post OP. , Spirometric lung function (GE easy one spirometer), Pulsseoximetric saturation (GE Monitoring), VAS scale

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Secondary Outcome

VAS SCore at the respective fixed time points. T0h, T1h, T2h, T6h, T24h

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/01/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Hip surgery, scheduled for general anesthesia, no further relvant deseases

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Exclusion Criteria

COPD, Cardiac desease NYHA III+IV, ASA >3, smoker

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Addresses

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    • Uniklinikum Marburg
    • Mr.  Dr. med.  Martin  Zoremba 
    • Baldingerstraße 1
    • 35033  Marburg
    • Germany
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    • Uniklinikum Marburg
    • Mr.  Dr. med.  Martin  Zoremba 
    • Baldingerstraße 1
    • 35033  Marburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinikum Marburg
    • Mr.  Dr. med.  Martin  Zoremba 
    • Baldingerstraße 1
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinikum Marburg
    • Mr.  Dr. med.  Martin  Zoremba 
    • Baldingerstraße 1
    • 35033  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/10/01
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Trial Publications, Results and other Documents

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