Trial document





This trial has been registered retrospectively.
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  DRKS00010155

Trial Description

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Title

Dyscomfort of puncture of peripheral veins or A. radialis after preparation of the local puncture site with cryoanaesthesia or local lidocaine infiltration

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Puncture of peripheral veins for inserting a venous catheter is a routine measure, which is carried out worldwide in every hospital hundreds of times a day.
Cannulation of the radial artery is also a routine procedure when invasive (directly in the artery) blood pressure measurement is reuqired.

Every puncture is unpleasant and painful for the patient. Thus, different measures to reduce the dyscomfort of puncture need to be investigated.

Creams containing local anesthetics, which are applied to the possible puncture site 1-2 hours before puncture, are common practise in the field of pediatrics. but unusual in adults due to the high logistical efforts and insufficient awareness of the bothersomeness of puncture dyscomfort among treating doctors.

Therefore, its the aim of the present study, to compare two easy implementable methods for reducing the dyscomfort during preparation und pucture of a peripheral vein or the a. radialis, respectively.

One is cryoanaesthesia induced by rapidly evaporating liquid (n-butane, n-propane mixture) applied locally and the other one is a local intradermal (in arterial puncture also subcutaneous) infiltration with a local anesthetic (2% lidocaine).

In the cohort of patients undergoing perpheral venous cannulation a control group is also carried along without intervention. Furthermore in this group of patients the impact of different cannual sizes (17G versus 20G) are examined.

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Brief Summary in Scientific Language

The dyscomfort induced by the preparation and the puncture of a peripheral vein in the back of the hand (cohort A) or cannulation of the radial artery is investigated. Local preparation consits of a hryoanaesthesia induced by a vapocoolant and is compared with the intradermal / subcutaneous infiltration with 2% lidocaine. In patients undergoing peripheral venous access a third group receiving no puncture site preparation serves as the control group. In these patients the impact of different cannula sizes (17G versus 20G) is investigated using a full-factorial disign (6 groups).

The total dyscomfort of the entire puncture procedure (including local preparation and pucture) are assessed using an 11-point verbal rating scale.

The procedure for puncture was designed so that the patient had no knowledge of the way of preparation ("patient-blinded"). For this purpose the following procedure was used:
0) patient turns the head to the opposite side; this is monitored until the end of the puncture by a study-nurse
1) Disinfection of the puncture site with an alcohol swab. Procedure is stopped at end of step 3 until the puncture site is dry.
2) preparation and assembling all neccessary material
3) Opening an envelope (smallest unused numbers) containing the assignment of patient to one of the study groups ( "allocation concealment")
4. Standardized notice to the patient "it is now going to be cold"
5a) in patients receiving lidocaine-infiltration or patients without intervention (only cohort with venipuncture): alcohol spray
5b) in patients receiving kryoanaesthesia: alkane spray on puncture site
6) Standardized notice to patient: "I begin now with the puncture"
7a) in patients receiving lidocaine-infiltration: local infiltration with lidocaine (27G needle): immediately afterwards venepuncture with cannula (17G or 20G) or arterial cannulation with a 20G needle without further announcement
7b) in patients receiving crypanaesthesia and patients the control group without intervention (only cohort with venepuncture): start of venepuncture with 17G or 20G needle or puncture of the radial artery with 20G needle.

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Organizational Data

  •   DRKS00010155
  •   2016/03/18
  •   [---]*
  •   yes
  •   Approved
  •   103/02, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   pain and dyscomfort induced by cannulation and local site preparation
  •   R52.0 -  Acute pain
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Interventions/Observational Groups

  •   Cohort venipuncture:
    Control: puncture of a vein at the back of the hand without physical or pharmacological preparation. Before venepuncture a standardized verbal announcement was given to the patient "it will be cold at the back of your hand" with subsequent spraying at the puncture site with alcohol spray, followed by a standardized verbal announcement "I will now begin with the puncture" and subsequent puncture of the vein with a 17G or 20G IV needle (stratified allocation according to the full-factorial design of the study).

    Cohort "arterial puncture": not applicaple
  •   intradermal (in cohort with arterial cannulation also subcutaneous) infiltration with lidocaine using a 27G cannula.
  •   Kryoanaesthesia by short (2-3 seconds) spraying with an alkane mixuture until the skin turns into a white color (by freezing humidity on the skin). Kryoanaesthesia was provided with "EisSpray" (ratiopharma GmbH, Deutschland).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, data analyst
  •   Control group receives no treatment
  •   Prevention
  •   Factorial
  •   N/A
  •   No
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Primary Outcome

1) puncture failure rate
2) Dyskomfort the entire puncture process (rating on a 11-point verbal numeric rating scale, where 0 is no dyscomfort and 11 is maximal imageable dyscomfort.

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Secondary Outcome

1) Time required until puncture
2) Time required for preparation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2005/05/01
  •   450
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

cohort A (venous cannulation):
- patient able to understand
- adequate venous situation at the back of the hand
- indication for peripheral venous access (preoperatively)
cohort B (arterial cannulation):
- patient able to understand
- palpable radial artery
- free flow in the ipilateral A. ulnaris
- indication for arterial cannulation (preoperatively)

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Exclusion Criteria

- Skin changes at the puncture site
- M. Raynaud
- Allergies / intolerance refrigerant or lidocaine

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Addresses

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    • Philipps-Universität Marburg
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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    • Klinik für Anästhesie & IntensivtherapiePhilipps-Universität Marburg
    • Mr.  Prof. (apl) Dr.  Leopold  Eberhart 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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    • Klinik für Anästhesie & IntensivtherapiePhilipps-Universität Marburg
    • Mr.  Prof. (apl) Dr.  Leopold  Eberhart 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesie & IntensivtherapiePhilipps-Universität Marburg
    • Mr.  Prof. (apl) Dr.  Leopold  Eberhart 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/03/01
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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.