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    Clinical Trial Results:
    Supraclavicular catheter for regional anesthesia of the shoulder - an explorative study in healthy volunteers.

    Summary
    EudraCT number
    		 2016-002835-14
    Trial protocol
    		 DK  
    Global end of trial date
    24 Aug 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SCCCSH01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark, 3400
    Public contact
    Department of anesthesiology, Nordsjællands Hospital Hillerød, kai.henrik.wiborg.lange@regionh.dk
    Scientific contact
    Department of anesthesiology, Nordsjællands Hospital Hillerød, kai.henrik.wiborg.lange@regionh.dk
    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 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to place a supraclavicular catheter in 32 healthy volunteers and examine: 1: If the largest shoulder nerves are affected 2: which other nerves are affected after injection with a low (5ml) or a high (20 ml) volume of ropivacain 5 mg/ml.
    Protection of trial subjects
    Local analgetic skin infiltration before insertion of nerve catheter.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Denmark: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 32
    Number of subjects completed
    		 32

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 ml Ropivacaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    5 ml Ropivacaine 5 mg*ml-1 administered perineurally in relation to the brachial plexus at a supraclavicular level.

    Arm title
    		 20 ml ropivacaine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20 ml Ropivacaine 5 mg*ml-1 administered perineurally in relation to the brachial plexus at a supraclavicular level.

    Number of subjects in period 1
    		5 ml Ropivacaine 20 ml ropivacaine
    Started
    16
    16
    Completed
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5 ml Ropivacaine
    Reporting group description
    		 -

    Reporting group title
    20 ml ropivacaine
    Reporting group description
    		 -

    Reporting group values
    		 5 ml Ropivacaine 20 ml ropivacaine Total
    Number of subjects
    		 16 16 32
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.7 ± 8.2 25.3 ± 3.2 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 18
        Male
    		 7 7 14

    End points

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    End points reporting groups
    Reporting group title
    5 ml Ropivacaine
    Reporting group description
    		 -

    Reporting group title
    20 ml ropivacaine
    Reporting group description
    		 -

    Primary: Shoulder nerve block

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    End point title
    		 Shoulder nerve block
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Number
    13
    15
    Statistical analysis title
    		 Shoulder nerves affected
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.9
    Notes
    [1] - Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the difference between proportions of succesful shoulder blocks in the 5 ml group vs the 20 ml group being greater than -0.2. As the difference in proportions was above -0.2 and the upper bound of the 95% CI was above zero, our results were inconclusive.

    Secondary: Change in spirometry (VC)

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    End point title
    		 Change in spirometry (VC)
    End point description
    The relative change in spirometry (VC) from baseline to 45 minutes after injection of ropivacain 0.5%.
    End point type
    Secondary
    End point timeframe
    T0-T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Litres
        arithmetic mean (standard deviation)
    -2.6 ± 9.8
    -10.6 ± 8.9
    Statistical analysis title
    		 Change in spirometry (VC)
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in spirometry (FVC)

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    End point title
    		 Change in spirometry (FVC)
    End point description
    The relative change in spirometry (FVC) from baseline to 45 minutes after injection of ropivacain 0.5%.
    End point type
    Secondary
    End point timeframe
    T0-T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Litres
        arithmetic mean (standard deviation)
    -1.1 ± 8.9
    -6.4 ± 9.3
    Statistical analysis title
    		 Change in spirometry (FVC)
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.113
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in spirometry (FEV1)

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    End point title
    		 Change in spirometry (FEV1)
    End point description
    The relative change in spirometry (FEV1) from baseline to 45 minutes after injection of ropivacain 0.5%.
    End point type
    Secondary
    End point timeframe
    T0-T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Litres
        arithmetic mean (standard deviation)
    -2.7 ± 9.3
    -8.8 ± 7.1
    Statistical analysis title
    		 Change in spirometry (FEV1)
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in spirometry (PEF)

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    End point title
    		 Change in spirometry (PEF)
    End point description
    The relative change in spirometry (PEF) from baseline to 45 minutes after injection of ropivacain 0.5%.
    End point type
    Secondary
    End point timeframe
    T0-T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Litres per minute
        arithmetic mean (standard deviation)
    0.7 ± 15.4
    -6.7 ± 8.8
    Statistical analysis title
    		 Change in spirometry (PEF)
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Complete phrenic nerve block

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    End point title
    		 Complete phrenic nerve block
    End point description
    Number of subjects with a complete unilateral phrenic nerve block defined as a reduction in FVC of at least 20%.
    End point type
    Secondary
    End point timeframe
    T0-T45
    End point values
    		 5 ml Ropivacaine 20 ml ropivacaine
    Number of subjects analysed
    16
    16
    Units: Number
    0
    2
    Statistical analysis title
    		 Phrenic nerve block
    Comparison groups
    5 ml Ropivacaine v 20 ml ropivacaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    July to september 2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    DK 2015
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (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
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    Nervous system disorders
    Subjektiv muskelsvaghed
    Additional description: Subjective muscle weakness
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1

    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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