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    Clinical Trial Results:
    The influence of different doses of local anaesthetics on the sensory distribution of lateral femoral cutaneous nerve block - a randomised, blinded, paired trial in heathy volunteers

    Summary
    EudraCT number
    		 2016-004936-39
    Trial protocol
    		 DK  
    Global end of trial date
    09 Jun 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 May 2021
    First version publication date
    07 Jan 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of short name

    Trial information

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    Trial identification
    Sponsor protocol code
    SM2-KHT-2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03138668
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Anesthesiology
    Sponsor organisation address
    Ringstedgade 61, Næstved, Denmark, 4700
    Public contact
    Office, Department of Anesthesiology, Næstved Hospital, 45 56514002, anaestesisekretariat@regionsjaelland.dk
    Scientific contact
    Office, Department of Anesthesiology, Næstved Hospital, 45 56514002, anaestesisekretariat@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
    09 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the sensory distribution of a LFCN-block with two different doses
    Protection of trial subjects
    The participants were healthy volanteers. Each participant got to blocks, one on each side. There were not taken special measurments regarding pain, as, local anesthesia at the point of injection also would create pain. The sourroundings however where kept quite, and participants had privacy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 May 2017
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 50 paritcipants were assessed for eligibility, 30 participants were excluded due to not meeting inclusion criteria, not eligible for study dates, declined participation

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 LFCN-block with 8 mL ropivacaine 0.75% on their right side and a LFCN-block containing 16 mL ropivacaine 0.75% on the left side.
    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
    Dosage 60 mg or 120 mg, given perineural at the lateral femoral cutaneous nerve.

    Arm title
    		 Group B
    Arm description
    		 LFCN-block with 16 mL ropivacaine 0.75% on their right side and a LFCN-block containing 8 mL ropivacaine 0.75% on the left side.
    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
    Dosage 60 mg or 120 mg, given perineural at the lateral femoral cutaneous nerve.

    Number of subjects in period 1
    		Group A Group B
    Started
    11
    9
    Completed
    11
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 20 20
    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)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 25 (19 to 49) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 13 13
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 176 (164 to 186) -
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 70 (55 to 85) -
    Quadriceps femoris, MVIC, right leg
    Maximum Voluntary Isometric Contraction of quadriceps femoris
    Units: kg
        arithmetic mean (full range (min-max))
    		 41 (26 to 58) -
    Quadriceps femoris, MVIC, left leg
    Maximum Voluntary Isometric Contraction of quadriceps femoris
    Units: kg
        arithmetic mean (full range (min-max))
    		 44 (26 to 63) -
    Heat stimulation, VAS, right leg
    Visual Analogue Score of pain during heat stimulation.
    Units: mm
        arithmetic mean (full range (min-max))
    		 41 (9 to 96) -
    Heat stimulation, VAS, left leg
    Visual Analogue Score of pain during heat stimulation.
    Units: mm
        arithmetic mean (full range (min-max))
    		 44 (11 to 94) -

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 LFCN-block with 8 mL ropivacaine 0.75% on their right side and a LFCN-block containing 16 mL ropivacaine 0.75% on the left side.

    Reporting group title
    Group B
    Reporting group description
    		 LFCN-block with 16 mL ropivacaine 0.75% on their right side and a LFCN-block containing 8 mL ropivacaine 0.75% on the left side.

    Primary: Coverage of posterior incision by temperature discrimination test

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    End point title
    		 Coverage of posterior incision by temperature discrimination test
    End point description
    End point type
    Primary
    End point timeframe
    One hour post block
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Difference of Coverage of post incision by temp
    Statistical analysis description
    Diffence of the coverage of posterior incision by temperature discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.345
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3.5

    Secondary: Coverage of lateral incision by temperature discrimination test

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    End point title
    		 Coverage of lateral incision by temperature discrimination test
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 19.3)
    19.5 (0 to 45.3)
    Statistical analysis title
    		 Difference of Coverage of lateral incision by temp
    Statistical analysis description
    Diffence of the coverage of lateral incision by temperature discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.221
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 24.5

    Secondary: Coverage of posterior incision by mechanical discrimination test

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    End point title
    		 Coverage of posterior incision by mechanical discrimination test
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Difference of Coverage of post incision by mech
    Statistical analysis description
    Diffence of the coverage of posterior incision by mechanical discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.715
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Secondary: Coverage of lateral incision by mechanical discrimination test

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    End point title
    		 Coverage of lateral incision by mechanical discrimination test
    End point description
    End point type
    Secondary
    End point timeframe
    On hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 20.3)
    0 (0 to 29.5)
    Statistical analysis title
    		 Difference of Coverage of lateral incision by mech
    Statistical analysis description
    Diffence of the coverage of lateral incision by mechanical discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 16.5

    Secondary: Blocked area assessed by temperature discrimination test

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    End point title
    		 Blocked area assessed by temperature discrimination test
    End point description
    End point type
    Secondary
    End point timeframe
    On hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: square centimeter
        arithmetic mean (standard deviation)
    418 ( 225 )
    564 ( 182.7 )
    Statistical analysis title
    		 Difference of blocked area, by temp discrimination
    Statistical analysis description
    Difference of blocked area assessed by temperature discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    146.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.7
         upper limit
    		 256.9

    Secondary: Blocked area assessed by mechanical discrimination test

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    End point title
    		 Blocked area assessed by mechanical discrimination test
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: square centimeter
        arithmetic mean (standard deviation)
    369 ( 211.4 )
    461 ( 156 )
    Statistical analysis title
    		 Difference of blocked area, by mech discrimination
    Statistical analysis description
    Difference of blocked area assessed by mechanical discrimination test.
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    92.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.8
         upper limit
    		 176.6

    Secondary: Post-block MVIC ≤80% of baseline

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    End point title
    		 Post-block MVIC ≤80% of baseline
    End point description
    End point type
    Secondary
    End point timeframe
    1 hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: number
    2
    2
    No statistical analyses for this end point

    Secondary: No pain during THS at superior portion of posterior incision

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    End point title
    		 No pain during THS at superior portion of posterior incision
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: number
    0
    0
    No statistical analyses for this end point

    Secondary: No pain during THS at superior portion of lateral incision

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    End point title
    		 No pain during THS at superior portion of lateral incision
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: number
    0
    0
    No statistical analyses for this end point

    Secondary: No pain during THS at inferior portion of posterior incision

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    End point title
    		 No pain during THS at inferior portion of posterior incision
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: number
    0
    1
    No statistical analyses for this end point

    Secondary: No pain during THS at inferior portion of lateral incision

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    End point title
    		 No pain during THS at inferior portion of lateral incision
    End point description
    End point type
    Secondary
    End point timeframe
    One hour post block.
    End point values
    		 Group A Group B
    Number of subjects analysed
    11
    9
    Units: number
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    In the period from admission of the first block until 2 hours after admission of the last block.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICH-GCP
    Dictionary version
    Revision 2
    Reporting groups
    Reporting group title
    Overall adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Overall adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    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 the observation period no Adverse Events observed.

    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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