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    Clinical Trial Results:
    Ultrasound-guided nerve block of the anterior femoral cutaneous nerves in healthy volunteers

    Summary
    EudraCT number
    		 2018-004986-15
    Trial protocol
    		 DK  
    Global end of trial date
    07 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2019
    First version publication date
    13 Nov 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Protocol_AFCN_17022019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle-Juul Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Siska Bjørn , Aarhus University Hospital, +45 60651087, siska.bjoern@post.au.dk
    Scientific contact
    Thomas Fichtner Bendtsen , Aarhus University Hospital, +45 51542997, tfb@dadlnet.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
    31 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this volunteer trial was to investigate the success of cutaneous anesthesia of the surgical incision for total knee arthroplasty (TKA) when adding a block of the intermediate femoral cutaneous nerve (IFCN) to a proximal femoral triangle block (FTB). Our primary hypothesis was that proximal FTB combined with IFCNB would provide superior cutaneous anesthesia of the surgical incision line compared to proximal FTB alone.
    Protection of trial subjects
    This volunteer trial was conducted in accordance with the Declaration of Helsinki and approved by the Danish Medicines Agency (2019023631), The Central Denmark Region Committees on Health Research Ethics (1-10-72-366-18) and the Danish Data Protection Agency. The trial was prospectively registered in the EudraCT database (2018-004986-15) and was monitored by the Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals. Prior to inclusion, written informed consent was obtained from all subjects after a thorough oral and written participant information had been given.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 2019
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Healthy volunteers of 18 years or older were recruited through a Danish website dedicated to recruit volunteers for research (www.forsøgsperson.dk). All volunteers received payment for their participation.

    Pre-assignment
    Screening details
    		 Inclusion criteria: > 18 years, ASA score I-II. Exclusion criteria: inability to cooperate/communicate in Danish, weight <60 kg, BMI > 28 kg/m2, lower limb neuropathy, chronic opioid-requiring pain, infection in the areas of injection, pregnancy, allergy to local anesthetic and daily consumption of medicine apart from oral contraceptives.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Randomization group 1
    Arm description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine). Leg leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline).
    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
    Each volunteer received a total of 40 ml ropivacaine 5 mg/ml = 200 mg ropivacaine during the entire trial period (5-6 hours)

    Investigational medicinal product name
    Sodium chloride 0.9 %
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Each volunteer received a total of 40 ml normal saline during the entire trial period (5-6 hours)

    Arm title
    		 Randomization group 2
    Arm description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline). Left leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine).
    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
    Each volunteer received a total of 40 ml ropivacaine 5 mg/ml = 200 mg ropivacaine during the entire trial period (5-6 hours)

    Investigational medicinal product name
    Sodium chloride 0.9 %
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Each volunteer received a total of 40 ml normal saline during the entire trial period (5-6 hours)

    Arm title
    		 Randomization group 3
    Arm description
    		 Right leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline)
    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
    Each volunteer received a total of 40 ml ropivacaine 5 mg/ml = 200 mg ropivacaine during the entire trial period (5-6 hours)

    Investigational medicinal product name
    Sodium chloride 0.9 %
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Each volunteer received a total of 40 ml normal saline during the entire trial period (5-6 hours)

    Arm title
    		 Randomization group 4
    Arm description
    		 Right leg: PLACEBO distal FTB (20 ml saline) +ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine)
    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
    Each volunteer received a total of 40 ml ropivacaine 5 mg/ml = 200 mg ropivacaine during the entire trial period (5-6 hours)

    Investigational medicinal product name
    Sodium chloride 0.9 %
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Each volunteer received a total of 40 ml normal saline during the entire trial period (5-6 hours)

    Number of subjects in period 1
    		Randomization group 1 Randomization group 2 Randomization group 3 Randomization group 4
    Started
    10
    10
    10
    10
    Completed
    10
    10
    10
    10

    Baseline characteristics

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

    Reporting group values
    		 overall period Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 40
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27 ± 6.9 -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 25 25
    ASA score
    Units: Subjects
        ASA I
    		 40 40
        ASA II
    		 0 0
    BMI
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 23 ± 1.9 -

    End points

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    End points reporting groups
    Reporting group title
    Randomization group 1
    Reporting group description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine). Leg leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline).

    Reporting group title
    Randomization group 2
    Reporting group description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline). Left leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine).

    Reporting group title
    Randomization group 3
    Reporting group description
    		 Right leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline)

    Reporting group title
    Randomization group 4
    Reporting group description
    		 Right leg: PLACEBO distal FTB (20 ml saline) +ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine)

    Subject analysis set title
    Active proximal FTB + active IFCNB
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active proximal FTB + active IFCNB = randomization group 2 + 3

    Subject analysis set title
    Active proximal FTB + placebo IFCNB
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active proximal FTB + placebo IFCNB = randomization group 1 + 4

    Subject analysis set title
    Active distal FTB + active IFCNB
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active distal FTB + active IFCNB = randomization groups 1 + 4

    Subject analysis set title
    Active distal FTB + placebo IFCNB
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active dital FTB + placebo IFCNB = randomization groups 2 + 3

    Subject analysis set title
    Active proximal FTB (before IFCNB)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active proximal FTB. Data collection after the first block session before addition of the IFCNB (second block session)

    Subject analysis set title
    Active distal FTB (before IFCNB)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Active distal FTB. Data collection after the first block session before addition of the IFCNB (second block session)

    Subject analysis set title
    IFCNB right side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    IFCNB performed on the right side

    Subject analysis set title
    IFCNB left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    IFCNB performed on the left side

    Subject analysis set title
    Proximal FTB right side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Proximal FTB performed on the right side

    Subject analysis set title
    Proximal FTB left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Proximal FTB performed on the left side

    Subject analysis set title
    Distal FTB right side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Distal FTB performed on the right side

    Subject analysis set title
    Distal FTB left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Distal FTB performed on the left side

    Subject analysis set title
    IFCNB right + left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Each volunteer had IFCNB bilaterally. For the discomfort the volunteer was asked to give one total score for the discomfort during the IFCNB performance.

    Subject analysis set title
    Proximal FTB right + left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Each volunteer had proximal FTB bilaterally. For the discomfort the volunteer was asked to give one total score for the discomfort during the proximal FTB performance.

    Subject analysis set title
    Distal FTB right + left side
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Each volunteer had distal FTB bilaterally. For the discomfort the volunteer was asked to give one total score for the discomfort during the distal FTB performance.

    Primary: Success rate of complete anesthesia of the midline skin incision after proximal FTB combined with IFCNB compared to proximal FTB alone

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    End point title
    		 Success rate of complete anesthesia of the midline skin incision after proximal FTB combined with IFCNB compared to proximal FTB alone
    End point description
    Pinprick was performed 30 min after performance of the last block. Pinprick was performed using a sterile neurological examination pin (Neuropen, Owen Mumford, UK). Cutaneous anesthesia was graded as either complete or incomplete/absent.
    End point type
    Primary
    End point timeframe
    Standard midline incision for TKA drawn with UV pen at baseline. Pinprick testing performed 30 min after block performance.
    End point values
    		 Active proximal FTB + active IFCNB Active proximal FTB + placebo IFCNB
    Number of subjects analysed
    20
    20
    Units: No unit
        Complete anesthesia of the incision line
    15
    4
        Incomplete anesthesia of the incision line
    5
    16
    Statistical analysis title
    		 Primary outcome - Fischer's exact
    Statistical analysis description
    Fischer's exact test
    Comparison groups
    Active proximal FTB + active IFCNB v Active proximal FTB + placebo IFCNB
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Success rate of complete anesthesia of the incision line with distal FTB combined with IFCNB compared to distal FTB alone

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    End point title
    		 Success rate of complete anesthesia of the incision line with distal FTB combined with IFCNB compared to distal FTB alone
    End point description
    End point type
    Secondary
    End point timeframe
    Pinprick performed 30 minutes after the last block performance
    End point values
    		 Active distal FTB + active IFCNB Active distal FTB + placebo IFCNB
    Number of subjects analysed
    20
    20
    Units: No unit
        Complete anesthesia of the incision line
    7
    1
        Incomplete anesthesia of the incision line
    13
    19
    Statistical analysis title
    		 Secondary outcome - Fischer's exact
    Comparison groups
    Active distal FTB + active IFCNB v Active distal FTB + placebo IFCNB
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Success rate of complete anesthesia of the incision line with proximal FTB and IFCNB compared to distal FTB and IFCNB

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    End point title
    		 Success rate of complete anesthesia of the incision line with proximal FTB and IFCNB compared to distal FTB and IFCNB
    End point description
    End point type
    Secondary
    End point timeframe
    Pinprick performed 30 min after block performance
    End point values
    		 Active proximal FTB + active IFCNB Active distal FTB + active IFCNB
    Number of subjects analysed
    20
    20
    Units: No unit
        Complete cutaneous anesthesia of the incision line
    15
    7
        Incomplete cutaneous anesthesia of the incision
    5
    20
    Statistical analysis title
    		 Secondary outcome - Fischer's exact
    Comparison groups
    Active distal FTB + active IFCNB v Active proximal FTB + active IFCNB
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Frequency of a non-anesthetized gap on the anteromedial side between the expected areas of cutaneous anesthesia after proximal vs. distal FTB both combined with an IFCNB

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    End point title
    		 Frequency of a non-anesthetized gap on the anteromedial side between the expected areas of cutaneous anesthesia after proximal vs. distal FTB both combined with an IFCNB
    End point description
    End point type
    Secondary
    End point timeframe
    Pinprick performed 30 min after block placement
    End point values
    		 Active proximal FTB + active IFCNB Active distal FTB + active IFCNB
    Number of subjects analysed
    20
    20
    Units: No unit
        Gap at the anteromedial side
    2
    17
        No gap at the anteromedial side
    18
    3
    Statistical analysis title
    		 Secondary outcome - Fischer's exact
    Comparison groups
    Active distal FTB + active IFCNB v Active proximal FTB + active IFCNB
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Maximal extension of the cutaneous area of anesthesia

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    End point title
    		 Maximal extension of the cutaneous area of anesthesia
    End point description
    Maximal extension of the cutaneous area of anesthesia after proximal and distal FTB measured as the direct distance on a straight line from the tibial tuberosity to the point of maximal extension in the proximal, distal, medial and lateral direction.
    End point type
    Secondary
    End point timeframe
    Measured after pinprick testing at the data collection station.
    End point values
    		 Active proximal FTB (before IFCNB) Active distal FTB (before IFCNB)
    Number of subjects analysed
    40 [1]
    40 [2]
    Units: centimeter
    arithmetic mean (standard deviation)
        Maximal proximal extension
    26.1 ± 7.9
    12.1 ± 7.8
        Maximal distal extension
    34.0 ± 4.9
    33.7 ± 6.0
        Maximal medial extension
    22.7 ± 4.6
    18.1 ± 4.4
        Maximal lateral extension
    9.9 ± 1.9
    10.0 ± 2.7
    Notes
    [1] - 40 legs
    [2] - 40 legs
    No statistical analyses for this end point

    Secondary: Injection point for IFCNB

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    End point title
    		 Injection point for IFCNB
    End point description
    Distance from the intersection of the inguinal crease and the femoral artery to the injection point for IFCNB
    End point type
    Secondary
    End point timeframe
    Measured just before block performance
    End point values
    		 IFCNB right side IFCNB left side
    Number of subjects analysed
    40 [3]
    40 [4]
    Units: centimeter
        arithmetic mean (standard deviation)
    9.8 ± 1.8
    9.3 ± 2.0
    Notes
    [3] - 40 legs
    [4] - 40 legs
    No statistical analyses for this end point

    Secondary: Block performance time IFCNB

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    End point title
    		 Block performance time IFCNB
    End point description
    End point type
    Secondary
    End point timeframe
    Block performance time defined as the time from the start of ultrasound scanning to the end of the injection
    End point values
    		 IFCNB right side IFCNB left side
    Number of subjects analysed
    40 [5]
    40 [6]
    Units: minute
        arithmetic mean (standard deviation)
    3.2 ± 0.8
    3.4 ± 1.0
    Notes
    [5] - 40 legs
    [6] - 40 legs
    No statistical analyses for this end point

    Secondary: Block performance time proximal FTB

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    End point title
    		 Block performance time proximal FTB
    End point description
    End point type
    Secondary
    End point timeframe
    Block performance time defined as the time from the start of ultrasound scanning to the end of the injection
    End point values
    		 Proximal FTB right side Proximal FTB left side
    Number of subjects analysed
    40 [7]
    40 [8]
    Units: minute
        arithmetic mean (standard deviation)
    2.2 ± 0.8
    2.4 ± 0.8
    Notes
    [7] - 40 legs
    [8] - 40 legs
    No statistical analyses for this end point

    Secondary: Block performance time distal FTB

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    End point title
    		 Block performance time distal FTB
    End point description
    End point type
    Secondary
    End point timeframe
    Block performance time defined as the time from the start of ultrasound scanning to the end of the injection
    End point values
    		 Distal FTB right side Distal FTB left side
    Number of subjects analysed
    40 [9]
    40 [10]
    Units: minute
        arithmetic mean (standard deviation)
    2.1 ± 0.7
    2.3 ± 0.7
    Notes
    [9] - 40 legs
    [10] - 40 legs
    No statistical analyses for this end point

    Secondary: Discomfort during IFCNB performance

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    End point title
    		 Discomfort during IFCNB performance
    End point description
    Volunteers were asked to score the discomfort/pain during the performance of the IFCNB. Volunteers were asked to give one total score including both sides. Discomfort/pain was scored on the NRS 0-10
    End point type
    Secondary
    End point timeframe
    Evaluated after performance of the last nerve block
    End point values
    		 IFCNB right + left side
    Number of subjects analysed
    40 [11]
    Units: NRS 0-10
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    Notes
    [11] - Each volunteer gave a total score including both right and left leg
    No statistical analyses for this end point

    Secondary: Discomfort during proximal FTB performance

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    End point title
    		 Discomfort during proximal FTB performance
    End point description
    Volunteers were asked to score the discomfort/pain during the performance of the proximal FTB. Volunteers were asked to give one total score including both sides. Discomfort/pain was scored on the NRS 0-10.
    End point type
    Secondary
    End point timeframe
    Evaluated after performance of the last nerve block
    End point values
    		 Proximal FTB right + left side
    Number of subjects analysed
    40 [12]
    Units: NRS 0-10
        median (inter-quartile range (Q1-Q3))
    4 (2.5 to 5.5)
    Notes
    [12] - Each volunteer gave a total score including both right and left leg
    No statistical analyses for this end point

    Secondary: Discomfort during distal FTB performance

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    End point title
    		 Discomfort during distal FTB performance
    End point description
    Volunteers were asked to score the discomfort/pain during the performance of the distal FTB. Volunteers were asked to give one total score including both sides. Discomfort/pain was scored on the NRS 0-10.
    End point type
    Secondary
    End point timeframe
    Evaluated after performance of the last block
    End point values
    		 Distal FTB right + left side
    Number of subjects analysed
    40 [13]
    Units: NRS 0-10
        median (inter-quartile range (Q1-Q3))
    5 (3 to 6)
    Notes
    [13] - Each volunteer gave a total score including both right and left leg
    No statistical analyses for this end point

    Secondary: Reduction in knee extension force after IFCNB

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    End point title
    		 Reduction in knee extension force after IFCNB
    End point description
    Reduction of maximal force of knee extension after IFCNB
    End point type
    Secondary
    End point timeframe
    Knee extension force (measured as maximal voluntary isometric force (MVIC)). MVIC was measured at baseline, after the first block session (proximal + distal FTB) and after the second block session (IFCNB)
    End point values
    		 Active proximal FTB + active IFCNB Active distal FTB + active IFCNB
    Number of subjects analysed
    20
    20
    Units: newton
    median (standard deviation)
        MVIC knee extension before IFCNB
    252.6 ± 142.6
    332.1 ± 120.7
        MVIC knee extension after IFCNB
    237.6 ± 152.1
    314.8 ± 159.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of inclusion and up until 24 hours after inclusion
    Adverse event reporting additional description
    All adverse events were evaluated and followed-up by a specialist anesthetist.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Randomization group 1
    Reporting group description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine). Leg leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline).

    Reporting group title
    Randomization group 2
    Reporting group description
    		 Right leg: ACTIVE distal FTB (20 ml ropivacaine) +PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline). Left leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine).

    Reporting group title
    Randomization group 3
    Reporting group description
    		 Right leg: PLACEBO distal FTB (20 ml saline) + ACTIVE proximal FTB (10 ml ropivacaine) + ACTIVE IFCNB (10 ml ropivacaine) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + PLACEBO IFCNB (10 ml saline)

    Reporting group title
    Randomization group 4
    Reporting group description
    		 Right leg: PLACEBO distal FTB (20 ml saline) +ACTIVE proximal FTB (10 ml ropivacaine) + PLACEBO IFCNB (10 ml saline) Left leg: ACTIVE distal FTB (20 ml ropivacaine) + PLACEBO proximal FTB (10 ml saline) + ACTIVE IFCNB (10 ml ropivacaine)

    Serious adverse events
    		 Randomization group 1 Randomization group 2 Randomization group 3 Randomization group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Randomization group 1 Randomization group 2 Randomization group 3 Randomization group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    General disorders and administration site conditions
    Dizziness
    Additional description: Caused by orthostatic hypotension
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reduced cutaneous sensation
    Additional description: Resolved spontaneously the next day. No sequelae.
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Reduced muscle strength
    Additional description: Resolved spontaneously the next day. No sequelae.
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2019
    Amendment approved by the Ethics Committee March 8, 2019 and by the Danish Medicines Agency March 15, 2019. The amendment was approved before recruitment was started. The amendment was made to improve the design of the study and ropivacaine was changed from 7.5 mg/ml to 5 mg/ml to reduce the accumulated dose.

    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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