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    Clinical Trial Results:
    Ultrasound Guided Caudal Blockade in Children between 30 and 50kg: A Feasibility Study

    Summary
    EudraCT number
    		 2013-002359-14
    Trial protocol
    		 AT  
    Global end of trial date
    28 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2021
    First version publication date
    05 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS number: DRKS00005021
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Klaus Markstaller(Sponsor), contact person: Daniela Marhofer, Med. Universität Wien, Universitätsklinik für Anästhesie, Allg. Intesnivmedizin&Schmerztherapie, +43 14040041020, daniela.marhofer@meduniwien.ac.at
    Scientific contact
    Klaus Markstaller(Sponsor), contact person: Daniela Marhofer, Med. Universität Wien, Universitätsklinik für Anästhesie, Allg. Intesnivmedizin&Schmerztherapie, +43 14040041020, daniela.marhofer@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Caudal block is possible for children between 30 and 50kg body weight, no additional analgesic drugs were required during surgery
    Protection of trial subjects
    Anonymisation of the data, no name will be published, only iniditals
    Background therapy
    		 Premedication consisted in midazolam orally or iv. All children received an infusion of Elo-Mel isotone at a rate of 5 ml kg-1 h-1. General anaesthesia was induced with propofol 10 mg •ml-1 at 2−4 mg kg-1 and fentanyl 1 µg kg-1 to facilitate the insertion of a laryngeal mask. Anaesthesia was then maintained with sevoflurane at 1 MAC (end-expiratory) via laryngeal mask and spontaneous respiration. Where pre-induction establishment of a venous access was not possible, inhalation anaesthesia with sevoflurane 8 vol% was used for induction.
    Evidence for comparator
    		 Caudal anaesthesia is a common anaesthesiological procedure for children less than 25kg body weight
    Actual start date of recruitment
    30 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    9
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who have to undergo subumbilical surgery with a body weight 30-50kg are recruited in the Deaprtment of paediatric surgery.

    Pre-assignment
    Screening details
    		 Subjects undergo subumbilical surgery with a body weight 30-50kg

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed

    Period 1
    Period 1 title
    baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Caudal block for children with a body weight 30-50kg
    Arm description
    		 Children with a body weight 30-50kg has to undergo caudal block are recruitted
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine 3.1mg/ml
    Investigational medicinal product code
    Ropivacaine
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Epidural use
    Dosage and administration details
    1ml/kg bodyweight Ropivacaine 3.1mg/ml

    Number of subjects in period 1
    		Caudal block for children with a body weight 30-50kg
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 20 20
    Age categorical
    Children from 2 to 17 years ( 2groups: 2-11 years old and 12-17 years old)
    Units: Subjects
        Children (2-11 years)
    		 9 9
        Adolescents (12-17 years)
    		 11 11
    Gender categorical
    girls and boys are included
    Units: Subjects
        Female
    		 3 3
        Male
    		 17 17
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Children with a body weight 30-50kg has to undergo caudal block are recruitted

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    20
    Age categorical
    Children from 2 to 17 years ( 2groups: 2-11 years old and 12-17 years old)
    Units: Subjects
        Children (2-11 years)
    9
        Adolescents (12-17 years)
    11
    Age continuous
    Units:
        
    ( )
    Gender categorical
    girls and boys are included
    Units: Subjects
        Female
    3
        Male
    17

    End points

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    End points reporting groups
    Reporting group title
    Caudal block for children with a body weight 30-50kg
    Reporting group description
    		 Children with a body weight 30-50kg has to undergo caudal block are recruitted

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Children with a body weight 30-50kg has to undergo caudal block are recruitted

    Primary: Feasibility of a successful block

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    End point title
    		 Feasibility of a successful block
    End point description
    Feasibility of the caudal blockades in children with a body weight 30-50kg. If there are any movements of extremities or haemodynamic changes of 15% at time of skin incision the caudal block would have been considered as "unsuccessful".
    End point type
    Primary
    End point timeframe
    The block has to work 15 minutes after performing the block
    End point values
    		 Caudal block for children with a body weight 30-50kg Overall trial
    Number of subjects analysed
    20
    20
    Units: yes or not
    20
    20
    Statistical analysis title
    		 Descriptive Analysis, Pearson's correlation
    Statistical analysis description
    The presence of a normal distribution was checked by a one-sample Kolmogorov-Smirnov test, using statistical software (IBM SPSS Statistics, v. 20; IBM, Armonk, NY, USA). All data were descriptively analysed. Pearson’s correlation coefficient was used to evaluate associations between pharmacodynamics and body weight
    Comparison groups
    Caudal block for children with a body weight 30-50kg v Overall trial
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 Pearson's correlation
    Parameter type
    		 correlation coefficient
    Confidence interval
    Notes
    [1] - clinical case series study of feasibility
    [2] - no p-value

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    study period
    Adverse event reporting additional description
    failed block is predefined by a movement while skin inzision, preoperatively monitoring of the vital parameters (non invasive blood pressure, egg, oxygen saturation), neurological evaluation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 n.a.
    Dictionary version
    0
    Reporting groups
    Reporting group title
    failed block
    Reporting group description
    		 failed block is predefined by a movment while the skin incision

    Serious adverse events
    		 failed block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 failed block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: clinical case series study of feasibility none AE

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2014
    Protocol change: after 4 participants an amendment was done: instead of caudal block and sedation, general anaesthesia with larnygeal mask but under spontanous ventilation would be done. Reason: the need of sedation medication was too high, general anaesthesia under spontanous ventilation would be better and easier

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    no limitations and caveats
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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