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    Clinical Trial Results:
    Effect of a lateral nerve of the thigh block on post-operative pain among patients with pain (VAS>40mm) during flexion of the hip the first or second postoperative day

    Summary
    EudraCT number
    		 2014-003730-10
    Trial protocol
    		 DK  
    Global end of trial date
    21 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2017
    First version publication date
    17 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    001-2014-KHTY
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02344264
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Anesthesiology, Næstved Hospital
    Sponsor organisation address
    Ringstedgade 61, Næstved, Denmark, 4700
    Public contact
    Daniel Hägi-Pedersen, Department of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.dk
    Scientific contact
    Daniel Hägi-Pedersen, Department of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.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
    21 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effect of a lateral cutaneuos nerve block in patient with moderat to severe pain after total hip replacement surgery during active flexion af the hip the first or second postoperative day. VAS score.
    Protection of trial subjects
    Treated with usual care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2015
    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
    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)
    21
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients, which underwent a primary total hip replacement

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 First blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml
    Arm type
    		 Cross-reference

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    naropin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    60 milligrams

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    8 milliliters

    Arm title
    		 Group B
    Arm description
    		 First blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml
    Arm type
    		 Cross-reference

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    naropin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    60 milligrams

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    8 milliliters

    Number of subjects in period 1
    		Group A Group B
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 First blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml

    Reporting group title
    Group B
    Reporting group description
    		 First blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml

    Primary: Difference in VAS between NCFL and placebo during active 30 degrees hip flexion

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    End point title
    		 Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
    End point description
    End point type
    Primary
    End point timeframe
    45 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    35 (32 to 53)
    61.5 (44 to 72)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31
         upper limit
    		 -4
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups during active hip flexion 15 minutes

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    End point title
    		 Difference in mean VAS between the groups during active hip flexion 15 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    15 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    39.5 (29.25 to 55.25)
    58.5 (39 to 71.25)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group B v Group A
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 -5
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups during active hip flexion 30 minutes

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    End point title
    		 Difference in mean VAS between the groups during active hip flexion 30 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    30 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    44 (24.25 to 57)
    58.5 (38.75 to 70.25)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 0
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups during active hip flexion 60 minutes

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    End point title
    		 Difference in mean VAS between the groups during active hip flexion 60 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    60 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    34 (18.75 to 50)
    55 (24.75 to 70.5)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30
         upper limit
    		 -5
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups during active hip flexion 75 minutes

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    End point title
    		 Difference in mean VAS between the groups during active hip flexion 75 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    75 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    29
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    35.5 (18 to 53.5)
    49 (22.5 to 66)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23
         upper limit
    		 6
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups during active hip flexion 90 minutes

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    End point title
    		 Difference in mean VAS between the groups during active hip flexion 90 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    90 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    29
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    34.5 (15 to 51.25)
    50 (22.5 to 65)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25
         upper limit
    		 5
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 15 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 15 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    15 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    30.5 (14.25 to 45)
    37.5 (12 to 57.5)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17
         upper limit
    		 8
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 30 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 30 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    30 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    32 (14 to 41.75)
    37 (10 to 59.75)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 6
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 45 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 45 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    45 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    22.5 (9 to 39.25)
    37.5 (10.75 to 62.5)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 4
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 60 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 60 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    60 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    30
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    17.5 (9 to 32.5)
    28 (4 to 52)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 4
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 75 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 75 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    75 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    29
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    15 (5 to 32)
    25 (4.5 to 46.5)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Median difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18
         upper limit
    		 5
    Variability estimate
    Standard deviation

    Secondary: Difference in mean VAS between the groups at rest 90 minutes

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    End point title
    		 Difference in mean VAS between the groups at rest 90 minutes
    End point description
    End point type
    Secondary
    End point timeframe
    90 minutes
    End point values
    		 Group A Group B
    Number of subjects analysed
    30
    29
    Units: millimeter(s)
        median (inter-quartile range (Q1-Q3))
    15 (5 to 30.25)
    25 (1 to 42.5)
    Statistical analysis title
    		 Hodges-lehmann-estimator
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Hodges-lehmann-estimator
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 hours after first injection
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICH Guideline
    Dictionary version
    E6
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Only adverse events related to the study medication were included.

    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
    For support, Contact us.
    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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