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    Clinical Trial Results:
    THE PROGRAMMED INTERMITTENT EPIDURAL BOLUS ADRENALINE STUDY

    Summary
    EudraCT number
    		 2015-004397-14
    Trial protocol
    		 NO  
    Global end of trial date
    07 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2022
    First version publication date
    25 Apr 2022
    Other versions
    Summary report(s)
    		 programmed intermittend epidural bolus

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03043781
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Akershus University Hospital
    Sponsor organisation address
    Sykehusveien 25, Loerenskog, Norway, 1478 Loerenskog
    Public contact
    Professor, Akershus university hospital, +47 67964679, vegard.dahl@ahus.no
    Scientific contact
    Professor, Akershus university hospital, +47 67964679, vegard.dahl@ahus.no
    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
    10 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to investigate whether use of intermittent epidural bolus (IEB) + patient controlled epidural bolus (PCEA) results in lower epidural mixture use per time compared to continuous epidural infusion + PCEA in the setting of an adrenaline containing mixture.
    Protection of trial subjects
    We recruited women in labor scheduled for epidural analgesia
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2017
    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
    Norway: 151
    Worldwide total number of subjects
    151
    EEA total number of subjects
    151
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    151
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women in labor in need of epidural analgesia

    Pre-assignment
    Screening details
    		 age > 18, read and signed written informed consent, one fetus at term

    Period 1
    Period 1 title
    baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Monitor, Carer, Assessor, Data analyst
    Blinding implementation details
    Participants received either continuous infusion or pregrammed intermittent boluses of epidural analgesia

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 continuous
    Arm description
    		 received continuous infusion of analgesia or bolus once hourly
    Arm type
    		 Active comparator

    Investigational medicinal product name
    bupivacaine/adrenaline/fentanyl
    Investigational medicinal product code
    n.a
    Other name
    standard EDA mixture
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    5+5 ml bolus, then 5ml/hr

    Arm title
    		 intermittent
    Arm description
    		 bolus of 5 ml solution once hourly
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine/adrenaline/fentanyl
    Investigational medicinal product code
    n.a
    Other name
    standard EDA mixture
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    5+5 ml bolus, then 5ml once hourly

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Investigator had to be aware of type of intervention, however the parturient, midwife and the person assessing the outcome was blinded
    Number of subjects in period 1
    		continuous intermittent
    Started
    76
    75
    Completed
    75
    75
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    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
    		 151 151
    Age categorical
    Aged > 18 years and in labor
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 151 151
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adult women
    		 0 0
    Gender categorical
    women in labor > 18 year of age
    Units: Subjects
        Female
    		 151 151
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    continuous
    Reporting group description
    		 received continuous infusion of analgesia or bolus once hourly

    Reporting group title
    intermittent
    Reporting group description
    		 bolus of 5 ml solution once hourly

    Primary: total consumption

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    End point title
    		 total consumption
    End point description
    End point type
    Primary
    End point timeframe
    total consumtion og solution per houir during the analgetic time frame
    End point values
    		 continuous intermittent
    Number of subjects analysed
    75
    75
    Units: ml
        number (not applicable)
    9.0
    8.1
    Statistical analysis title
    		 student T-test
    Statistical analysis description
    mean difference in total consummption between groups
    Comparison groups
    continuous v intermittent
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.08 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 1.8
    Notes
    [1] - the actual measured P-value indicates no difference between groups

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    last included participant in the post-delivery ward
    Adverse event reporting additional description
    hypotenstion, total spinal effect etc
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no spescific
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: In these participating parturients, there were no adverse events

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32812652
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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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