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    Clinical Trial Results:
    Selective ultrasound-guided nerve block of the medial femoral cutaneous nerve in healthy volunteers

    Summary
    EudraCT number
    		 2020-004942-12
    Trial protocol
    		 DK  
    Global end of trial date
    13 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2022
    First version publication date
    20 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Protokol_MFCN_10102020
    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 165, Aarhus, Denmark,
    Public contact
    Siska Bjørn, Aarhus University, +45 60651087, siskabjoern@clin.au.dk
    Scientific contact
    Thomas Fichtner Bendtsen, Aarhus University, 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
    13 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate the success rate of anesthesia of the "gap" (non-anesthetized area) on the surgical incision used for total knee arthroplasty (TKA) after nerve block of the anterior branch from the medial femoral cutaneous nerve (MFCN) compared to the posterior branch of the MFCN.
    Protection of trial subjects
    This volunteer trial was conducted in accordance with the Declaration of Helsinki and approved by the Danish Medicines Agency, The Central Denmark Region Committees on Health Research Ethics and the Danish Data Protection Agency. The trial was prospectively registered in the EudraCT database 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. All nerve blocks in the trial were superficial cutaneous nerve blocks with very little discomfort for the volunteer.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2020
    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
    		 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: Age≥18, ASA I-II, informed consent. Exclusion criteria: Unable to cooperate, unable to speak or understand Danish, known neuropathy in the extremities, infection in the areas around the injection sites, BMI >28 kg/m2, pregnancy, allergy towards any. medical product in the trial, daily use of medicine except 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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Randomization group 1
    Arm description
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femoral triangle blocks (distal FTB, block round 2). Block round 3: active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch of the MFCN on the right side and vice versa on the left side.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Marcaine adrenaline
    Investigational medicinal product code
    Other name
    Bupivacaine with adrenaline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Marcaine adrenaline 2.5 mg/ml + 5 microgram/ml Cumulated dose: 160 mg

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Sodium chloride 9mg/ml used for the placebo nerve blocks.

    Arm title
    		 Randomization group 2
    Arm description
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femoral triangle blocks (distal FTB, block round 2). Block round 3: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4:active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch of the MFCN on the right side and vice versa on the left side.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Marcaine adrenaline
    Investigational medicinal product code
    Other name
    Bupivacaine with adrenaline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Marcaine adrenaline 2.5 mg/ml + 5 microgram/ml Cumulated dose: 160 mg

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Normal saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Sodium chloride 9mg/ml used for the placebo nerve blocks.

    Number of subjects in period 1 [1]
    		Randomization group 1 Randomization group 2
    Started
    9
    10
    Completed
    9
    10
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 20 volunteers were enrolled in the trial. One volunteer withdrew consent during block round 1 (before randomization). The withdrawal was due to personal reasons and not any adverse events. Therefore only 9 volunteers were randomized to group 1.

    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
    		 19 19
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.6 ± 2.8 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 13 13
    ASA group
    The ASA Physical Status Classification
    Units: Subjects
        ASA I
    		 19 19
        ASA II
    		 0 0
    Body mass index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 23.2 ± 1.9 -

    End points

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    End points reporting groups
    Reporting group title
    Randomization group 1
    Reporting group description
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femoral triangle blocks (distal FTB, block round 2). Block round 3: active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch of the MFCN on the right side and vice versa on the left side.

    Reporting group title
    Randomization group 2
    Reporting group description
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femoral triangle blocks (distal FTB, block round 2). Block round 3: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4:active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch of the MFCN on the right side and vice versa on the left side.

    Subject analysis set title
    Anterior branch of MFCN
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Volunteers with a gap after IFCNB and distal FTB (block round 1 + 2). Block of the anterior branch of the MFCN in block round 3.

    Subject analysis set title
    Posterior branch of the MFCN
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Volunteers with a gap on the incision line after IFCNB and distal FTB (block round 1 + 2). Addition of MFCN block in block round 4 (posterior branch of the MFCN)

    Primary: Success rate of anesthesia of the non-anesthetized gap on the midline incision after addition of selective MFCN-A versus addition of the MFCN-P to the combined IFCN block and distal FTB

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    End point title
    		 Success rate of anesthesia of the non-anesthetized gap on the midline incision after addition of selective MFCN-A versus addition of the MFCN-P to the combined IFCN block and distal FTB
    End point description
    Pinprick was performed using a sterile neurological examination pin (Neuropen, Owen Mumford, UK).
    End point type
    Primary
    End point timeframe
    Standard midline incision for TKA drawn with UV pen at baseline. Pinprick testing performed 30 min after each round of nerve blocks.
    End point values
    		 Anterior branch of MFCN Posterior branch of the MFCN
    Number of subjects analysed
    10
    10
    Units: No unit
        Complete anesthesia of the incision line
    9
    0
        Incomplete anesthesia of the incision line
    1
    10
    Statistical analysis title
    		 McNemar’s test
    Comparison groups
    Anterior branch of MFCN v Posterior branch of the MFCN
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mcnemar
    Confidence interval

    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
    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
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femora triangle blocks (distal FTB, block round 2). Block round 3: active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch on of the MFCN on the right side and vice versa on the left side.

    Reporting group title
    Randomization group 2
    Reporting group description
    		 All volunteers received bilateral active intermediate femoral cutaneous nerve blocks (IFCNB, block round 1) and active bilateral distal femora triangle blocks (distal FTB, block round 2). Block round 3: placebo block of the medial femoral cutaneous nerve (MFCN) combined with active block of the anterior branch on of the MFCN on the right side and vice versa on the left side. Block round 4:active block of the medial femoral cutaneous nerve (MFCN) combined with placebo block of the anterior branch on of the MFCN on the right side and vice versa on the left side.

    Serious adverse events
    		 Randomization group 1 Randomization group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Randomization group 1 Randomization group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
    Nervous system disorders
    Dizziness
    Additional description: Very brief vasovagal episode during block round 1 (before randomized study drug was given). The dizziness resolved after a few minutes with no interventions.
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0

    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.
    No significant limitations to report
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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