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    Clinical Trial Results:
    Sensory distribution of lateral femoral cutaneous nerve block - a randomised, blinded, paired trial in heathy volunteers

    Summary
    EudraCT number
    		 2016-002643-41
    Trial protocol
    		 DK  
    Global end of trial date
    19 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2021
    First version publication date
    13 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SM1-KHTY-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02957903
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Anaesthesiolgy
    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
    01 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2016
    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
    Protection of trial subjects
    The participants were healthy volanteers. Each participant got one block. 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
    11 Nov 2016
    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
    		 40 subjects were assessed for eligibility, 19 subjects were excluded due to not meeting inclusion criteria, not eligible for study dates, declined participation.

    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
    		 Intervention A
    Arm description
    		 Intervention A received a LCFN-block with 8 ml of 0.75% ropivacaine on the right side and a LCFN-block with 8 ml isotonic saline 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 of ropivacaine given perineural at the lateral cutaneous nerve.

    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
    Dosage 8 ml of isotonic saline given perineural at the lateral cutaneous nerve.

    Arm title
    		 Intervention B
    Arm description
    		 Intervention A received a LCFN-block with 8 ml of 0.75% ropivacaine on the left side and a LCFN-block with 8 ml isotonic saline on the right 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 of ropivacaine given perineural at the lateral cutaneous nerve.

    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
    Dosage 8 ml of isotonic saline given perineural at the lateral cutaneous nerve.

    Number of subjects in period 1
    		Intervention A Intervention 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
    		 Only the 20 enrolled patients are included in the baseline.

    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
    Age in years.
    Units: years
        arithmetic mean (standard deviation)
    		 24 ± 3 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 11 11
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 178 ± 9 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 73 ± 12 -
    BMI
    Body Mass Index
    Units: kg/squaremeter
        arithmetic mean (standard deviation)
    		 23 ± 2 -
    Length of right posterior incision line
    Units: cm
        arithmetic mean (standard deviation)
    		 11 ± 2 -
    Length of left posterior incision line
    Units: cm
        arithmetic mean (standard deviation)
    		 11 ± 2 -
    Length of right lateral incision line
    Units: cm
        arithmetic mean (standard deviation)
    		 12 ± 2 -
    Length of left lateral incision line
    Units: cm
        arithmetic mean (standard deviation)
    		 13 ± 1 -
    Maximum voluntary isometric contraction right side
    Units: kg
        arithmetic mean (standard deviation)
    		 41 ± 12 -
    Maximum voluntary isometric contraction left side
    Units: cm
        arithmetic mean (standard deviation)
    		 41 ± 13 -
    Heat pain detection threshold right side
    Units: degree celcius
        arithmetic mean (standard deviation)
    		 45 ± 2 -
    Heat pain detection threshold right side
    Units: degree celcius
        arithmetic mean (standard deviation)
    		 45 ± 3 -
    Tonic heat stimulation right side
    Tonic heat stimulation measured with visual analog scale.
    Units: mm
        arithmetic mean (standard deviation)
    		 40 ± 20 -
    Tonic heat stimulation left side
    Tonic heat stimulation measured with visial analog scale.
    Units: mm
        arithmetic mean (standard deviation)
    		 39 ± 21 -

    End points

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    End points reporting groups
    Reporting group title
    Intervention A
    Reporting group description
    		 Intervention A received a LCFN-block with 8 ml of 0.75% ropivacaine on the right side and a LCFN-block with 8 ml isotonic saline on the left side.

    Reporting group title
    Intervention B
    Reporting group description
    		 Intervention A received a LCFN-block with 8 ml of 0.75% ropivacaine on the left side and a LCFN-block with 8 ml isotonic saline on the right side.

    Subject analysis set title
    Active
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects for Intervention A and B with their active side.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjectes in intervention group A and B with their placebo side.

    Primary: Difference in the percentage coverage of the posterior incicsion line with temperature discrimination

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    End point title
    		 Difference in the percentage coverage of the posterior incicsion line with temperature discrimination
    End point description
    Predefined as the difference in the percentage coverage of the posterior incision line assessed bytemperature discrimination test with alcohol soaked gauze,11 between the side given ropivacaine and the side given isotonic saline.
    End point type
    Primary
    End point timeframe
    1 hour after application of the block
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    5.8 ± 17.2
    0.0 ± 0
    Statistical analysis title
    		 Paired students t-test
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.146
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 14

    Secondary: Difference in the percentage coverage of the lateral incicsion line with temperature discrimination

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    End point title
    		 Difference in the percentage coverage of the lateral incicsion line with temperature discrimination
    End point description
    Predefined as the difference in the percentage coverage of the lateral incision line assessed bytemperature discrimination test with alcohol soaked gauze,11 between the side given ropivacaine and the side given isotonic saline.
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    18.9 ± 26.6
    0.0 ± 0.0
    Statistical analysis title
    		 Paired students t-test
    Statistical analysis description
    Mean difference between active and placebo side.
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 31.4

    Secondary: Difference in the percentage coverage of the posterior incicsion line with pinprick

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    End point title
    		 Difference in the percentage coverage of the posterior incicsion line with pinprick
    End point description
    Coverage of the posterior incision line assessed by pinprick
    End point type
    Secondary
    End point timeframe
    1 hour after block
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    4.3 ± 8.7
    0.0 ± 0.0
    Statistical analysis title
    		 Mean difference pinprick posterior incision
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 8.4

    Secondary: Difference in the percentage coverage of the lateral incicsion line with pinprick

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    End point title
    		 Difference in the percentage coverage of the lateral incicsion line with pinprick
    End point description
    Coverage of the posterior incision line assessed by pinprick
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: percent
        arithmetic mean (standard deviation)
    22.7 ± 32.3
    0.0 ± 0.0
    Statistical analysis title
    		 Mean difference pinprick lateral incision
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.6
         upper limit
    		 37.7

    Secondary: Heat pain detection threshold posterior line, superior point

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    End point title
    		 Heat pain detection threshold posterior line, superior point
    End point description
    HPDT, a computer-controlled thermode set to heat by 1°C/s from 32 to 52°C was used to assess the lowest temperature that was perceived as painful. The participants pushed a button, when the heat sensation turned into a sensation of pain.
    End point type
    Secondary
    End point timeframe
    1 hour after block
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: degree celsius
        arithmetic mean (standard deviation)
    45.0 ± 2.6
    46.1 ± 2.4
    Statistical analysis title
    		 Mean difference HPDT posterior incision line
    Statistical analysis description
    Superior point
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.9

    Secondary: Heat pain detection threshold posterior line, inferior point

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    End point title
    		 Heat pain detection threshold posterior line, inferior point
    End point description
    HPDT, a computer-controlled thermode set to heat by 1°C/s from 32 to 52°C was used to assess the lowest temperature that was perceived as painful. The participants pushed a button, when the heat sensation turned into a sensation of pain.
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: degree celsius
        arithmetic mean (standard deviation)
    45.5 ± 3.1
    45.2 ± 2.4
    Statistical analysis title
    		 Mean difference HPDT posterior incision line
    Statistical analysis description
    Inferior point
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.619
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 1.9

    Secondary: Heat pain detection threshold lateral line, superior point

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    End point title
    		 Heat pain detection threshold lateral line, superior point
    End point description
    HPDT, a computer-controlled thermode set to heat by 1°C/s from 32 to 52°C was used to assess the lowest temperature that was perceived as painful. The participants pushed a button, when the heat sensation turned into a sensation of pain.
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: degree celsius
        arithmetic mean (standard deviation)
    44.8 ± 2.3
    44.7 ± 3.1
    Statistical analysis title
    		 Mean difference HPDT lateral incision line
    Statistical analysis description
    Superior point
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.823
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.9

    Secondary: Heat pain detection threshold lateral line, inferior point

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    End point title
    		 Heat pain detection threshold lateral line, inferior point
    End point description
    HPDT, a computer-controlled thermode set to heat by 1°C/s from 32 to 52°C was used to assess the lowest temperature that was perceived as painful. The participants pushed a button, when the heat sensation turned into a sensation of pain.
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: degree celsius
        arithmetic mean (standard deviation)
    46.0 ± 3.8
    45.3 ± 2.3
    Statistical analysis title
    		 Mean difference HPDT lateral incision line
    Statistical analysis description
    Inferior point
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.387
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 2.2

    Secondary: Tonic heat stimulation posterior line, superior point

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    End point title
    		 Tonic heat stimulation posterior line, superior point
    End point description
    When testing pain during heat stimulation, the thermode heated to 45°C for 30 s and pain was assessed by the subject using Visual Analogue Score (VAS) from 0 to 100 mm (0 mm being no pain, 100 mm being worst pain imaginable).
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: mm
        arithmetic mean (standard deviation)
    30.3 ± 18.8
    33.0 ± 20.8
    Statistical analysis title
    		 Mean difference Tonic Heat posterior incision line
    Statistical analysis description
    Superior point
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 12.3

    Secondary: Tonic heat stimulation posterior line, inferior point

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    End point title
    		 Tonic heat stimulation posterior line, inferior point
    End point description
    When testing pain during heat stimulation, the thermode heated to 45°C for 30 s and pain was assessed by the subject using Visual Analogue Score (VAS) from 0 to 100 mm (0 mm being no pain, 100 mm being worst pain imaginable).
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: mm
        arithmetic mean (standard deviation)
    30.8 ± 23.1
    37.0 ± 21.8
    Statistical analysis title
    		 Mean difference Tonic Heat posterior incision line
    Statistical analysis description
    Inferior point
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 12.3

    Secondary: Tonic heat stimulation lateral line, superior point

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    End point title
    		 Tonic heat stimulation lateral line, superior point
    End point description
    When testing pain during heat stimulation, the thermode heated to 45°C for 30 s and pain was assessed by the subject using Visual Analogue Score (VAS) from 0 to 100 mm (0 mm being no pain, 100 mm being worst pain imaginable).
    End point type
    Secondary
    End point timeframe
    1 hour after block
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: mm
        arithmetic mean (standard deviation)
    32.2 ± 19.6
    36.7 ± 19.9
    Statistical analysis title
    		 Mean difference Tonic Heat lateral incision line
    Statistical analysis description
    Superior point
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 7.6

    Secondary: Tonic heat stimulation lateral line, inferior point

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    End point title
    		 Tonic heat stimulation lateral line, inferior point
    End point description
    When testing pain during heat stimulation, the thermode heated to 45°C for 30 s and pain was assessed by the subject using Visual Analogue Score (VAS) from 0 to 100 mm (0 mm being no pain, 100 mm being worst pain imaginable).
    End point type
    Secondary
    End point timeframe
    1 hour after block.
    End point values
    		 Active Placebo
    Number of subjects analysed
    20
    20
    Units: mm
        arithmetic mean (standard deviation)
    23.8 ± 20.0
    37.3 ± 20.5
    Statistical analysis title
    		 Mean difference Tonic Heat lateral incision line
    Statistical analysis description
    Inferior point
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00018
    Method
    		 Paired students t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.4
         upper limit
    		 19.7

    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
    		 Non-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
    0
    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: No adverse events are observed in the investigation period.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29468642
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