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    The EU Clinical Trials Register currently displays   43927   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    Jatkuvan haavapuudutuksen vaikutukset tavanomaiseen kipulääkitykseen lapsipotilailla sydänleikkauksen jälkeen

    Summary
    EudraCT number
    2008-008380-94
    Trial protocol
    FI  
    Global end of trial date
    07 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2020
    First version publication date
    01 Feb 2020
    Other versions
    Summary report(s)
    Ropivacaine infusion for post sternotomy pain

    Trial information

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    Trial identification
    Sponsor protocol code
    Sternumhaavapuudutus
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital
    Sponsor organisation address
    Stenbäckinkatu 11, Helsinki, Finland, 00029 HUS
    Public contact
    Department of Anesthesia and Intensive care, Helsinki University Hospital, +358 0504271648, arja.hiller@hus.fi
    Scientific contact
    Department of Anesthesia and Intensive care, Helsinki University Hospital, +358 0504271648, arja.hiller@hus.fi
    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
    31 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Examine whether the continuous infusion of 0.2% ropivacaine decreases daily morphine consumption for 72 h in children who were undergoing ASd closure.
    Protection of trial subjects
    The study was approved by the institutional Ethics Committee
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    49
    Adolescents (12-17 years)
    0
    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
    -

    Pre-assignment
    Screening details
    A total of 49 children aged 1-9 years of ASA physical status II-IV who were undergoing ASD repair were enrolled

    Period 1
    Period 1 title
    Postoperative (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Enrolled children were randomly assigned to a treatment by the sealed-envelope method. The study design was a series of blocks of fours, whereby a patient randomly received either a continuous wound infusion or ropivacaine or of saline. A nurse anesthetist who did not participate in the postoperative care of the enrolled children prepared all study medications according to the assigned group treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    saline
    Arm description
    continuos ropivacaine infusion was compare with same amount (ml) saline
    Arm type
    Placebo

    Investigational medicinal product name
    ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Unknown use
    Dosage and administration details
    drugs were given to wound catheter parallel into the sternal wound above mediastinum 0.2% ropivacaine as a bolus 0.5 ml/kg and thereafter as continuos infuusion 0.3-0.4 mg/kg/h

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Unknown use
    Dosage and administration details
    After skin closure, the surgeon injected a bolus of saline 0.5 ml/kg to wound catheter and thereafter continuous infusion of saline 1-7 ml/h depending on the weight of a child.

    Arm title
    ropivacaine
    Arm description
    Continuous ropivacaine infusion was compared with same amount (ml) of saline
    Arm type
    Active comparator

    Investigational medicinal product name
    ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Unknown use
    Dosage and administration details
    drugs were given to wound catheter parallel into the sternal wound above mediastinum 0.2% ropivacaine as a bolus 0.5 ml/kg and thereafter as continuos infuusion 0.3-0.4 mg/kg/h

    Number of subjects in period 1
    saline ropivacaine
    Started
    23
    26
    Completed
    23
    26

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    saline
    Reporting group description
    continuos ropivacaine infusion was compare with same amount (ml) saline

    Reporting group title
    ropivacaine
    Reporting group description
    Continuous ropivacaine infusion was compared with same amount (ml) of saline

    Primary: change in morphine consumption between groups during 72 h

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    End point title
    change in morphine consumption between groups during 72 h
    End point description
    Morphine consumption mg/kg Control Ropivacaine 0-24 h 0.63 (0.30) 0.68 (0.25) 24-48 h 0.16 (0.10) 0.20 (0.18) 48-72 h 0.06 (0.07) 0.07 (0.12)
    End point type
    Primary
    End point timeframe
    72 h
    End point values
    saline ropivacaine
    Number of subjects analysed
    23
    26
    Units: mg /kg
    number (confidence interval 95%)
        morphine consumption
    0.63 (0.43 to 0.71)
    0.68 (0.48 to 0.79)
    Statistical analysis title
    Statistical analysis
    Statistical analysis description
    Comparisons between the groups were performed using the Student`s t-test to compare means, the Mann-Whitney U-test to compare distributions nonparametrically, and Fisher´s exact test when appropriate.Normality of the distribution was assessed by Shapiro-Wilk W test, and depending on the results, either parametric or nonparametric analysis was performed. Data on demographics, surgery, anesthetics and doses of drug administered were analyzed using Student´´s t-test.
    Comparison groups
    saline v ropivacaine
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.5 [1]
    Method
    Fisher exact
    Parameter type
    Mean difference (final values)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.05
         upper limit
    0.05
    Variability estimate
    Standard deviation
    Notes
    [1] - A P-value <0.05 were considered significant.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During 24 hrs hourly, 24-72 h every fourth hour
    Adverse event reporting additional description
    Daily questionnaire for ward nurses
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    ropivacaine
    Reporting group description
    -

    Reporting group title
    control
    Reporting group description
    -

    Serious adverse events
    ropivacaine control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ropivacaine control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 26 (57.69%)
    18 / 23 (78.26%)
    General disorders and administration site conditions
    nausea and vomiting
         subjects affected / exposed
    15 / 26 (57.69%)
    18 / 23 (78.26%)
         occurrences all number
    57
    78

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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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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