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    Clinical Trial Results:
    A randomized trial of automated intermittent ropivacaine administration vs. continuous infusion in an interscalene catheter

    Summary
    EudraCT number
    		 2013-000235-27
    Trial protocol
    		 DK  
    Global end of trial date
    22 Mar 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-000235-27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense Universitets hospital
    Sponsor organisation address
    J. B. Winsløws Vej 4, Odense, Denmark, 5000
    Public contact
    Dep. V, Odense University Hospital, 45 66113333,
    Scientific contact
    Dep. V, Odense University Hospital, 45 66113333,
    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
    04 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigater wether we can reduce pain associated with shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection
    Protection of trial subjects
    Written informed consent was obtained from all subjects before enrollment. The investigators performed this.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2013
    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
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    20
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Written informed consent was obtained from all subjects before enrollment. The investigators performed this.

    Pre-assignment
    Screening details
    		 Patients were recruited in the Department of Orthopedic Surgery, Odense University Hospi- tal, Denmark. Inclusion criteria: Adult patients (aged ≥ 18 years, ASA 1-3) undergoing major shoulder surgery performed under general anesthesia with continuous inter- scalene nerve block.

    Pre-assignment period milestones
    Number of subjects started
    		 35 [1]
    Number of subjects completed
    		 35

    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 10 more patients were enrolled to ensure statistical significance
    Period 1
    Period 1 title
    Study period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 intervention
    Arm description
    		 ropivacain administation
    Arm type
    		 Experimental

    Investigational medicinal product name
    ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for suspension for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    2mg/ml 16ml/t

    Number of subjects in period 1 [2]
    		intervention
    Started
    35
    Completed
    35
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 10 more patients were enrolled to ensure statistical significance
    Period 2
    Period 2 title
    intervention
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Carer, Assessor, Subject

    Arms
    Arm title
    		 intervention
    Arm description
    		 control
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    16ml/t

    Number of subjects in period 2
    		intervention
    Started
    35
    Completed
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 -

    Reporting group values
    		 Study period Total
    Number of subjects
    		 35 35
    Age categorical
    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)
    		 15 15
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 24 24
    VAS
    VAS 1-10
    Units: Subjects
        VAS
    		 20 20
        morphine
    		 15 15
    Control
    Placebo saline
    Units: ml
        median (standard deviation)
    		 1 ( 1 ) -
    Subject analysis sets

    Subject analysis set title
    control
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo was administered (saline)

    Subject analysis set title
    intervention
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    ropivacain

    Subject analysis sets values
    		 control intervention
    Number of subjects
    35
    35
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    15
        From 65-84 years
    20
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    17
        Male
    18
    VAS
    VAS 1-10
    Units: Subjects
        VAS
    35
        morphine
    35
    Control
    Placebo saline
    Units: ml
        median (standard deviation)
    1 ( 1 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 ropivacain administation
    Reporting group title
    intervention
    Reporting group description
    		 control

    Subject analysis set title
    control
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    placebo was administered (saline)

    Subject analysis set title
    intervention
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    ropivacain

    Primary: VAS

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    End point title
    		 VAS [1]
    End point description
    VAS score from 1-10
    End point type
    Primary
    End point timeframe
    Through out the study period
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: due to technical complication it was not possible to assign a statistical analysis it can be viewed en the article
    End point values
    		 intervention
    Number of subjects analysed
    35
    Units: mg
    number (not applicable)
        VAS
    2.9
    No statistical analyses for this end point

    Secondary: morphine

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    End point title
    		 morphine
    End point description
    End point type
    Secondary
    End point timeframe
    through out the study
    End point values
    		 intervention intervention control intervention
    Number of subjects analysed
    35
    35
    35
    Units: mg
        medication
    35
    35
    35
    35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Through out the study
    Adverse event reporting additional description
    one patient experienced a lung embolism during the study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Danish medcal center
    Dictionary version
    1
    Reporting groups
    Reporting group title
    study group
    Reporting group description
    		 included patients

    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: This is right
    Serious adverse events
    		 study group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Lung embolism
    Additional description: One patient experienced a lung embolism during the study period was not considered in relation to the study
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 study group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)

    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.
    VAS might not be the best measure for effect

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29034961
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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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