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    Clinical Trial Results:
    Effect and safety of the iliopsoas plane block in healthy volunteers

    Summary
    EudraCT number
    		 2018-000089-12
    Trial protocol
    		 DK  
    Global end of trial date
    10 Jun 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    HIP/FUSION#4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Clinical Medicine, Aarhus University
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 165, Aarhus N, Denmark, 8200
    Public contact
    Niels Dalsgaard Nielsen, Center for Planlagt Kirurgi, Regionshospitalet Silkeborg, +45 22838334, nielsdn@dadlnet.dk
    Scientific contact
    Niels Dalsgaard Nielsen, Center for Planlagt Kirurgi, Regionshospitalet Silkeborg, +45 22838334, nielsdn@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
    14 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate, whether the iliopsoas plane block affects the muscle strength of the quadriceps femoris muscle.
    Protection of trial subjects
    No specific measures was used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    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
    		 We recruited healthy volunteers ≥ 18 years with an American Society of Anesthesiologists physical status classification score (ASA) I-II from a Danish website dedicated to recruit volunteers for research.

    Pre-assignment
    Screening details
    		 31 subjects were assessed for eligibility. 9 were excluded (6 meeting exclusion criteria; 3 withdrawing consent).

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

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 Active nerve block, left side
    Arm type
    		 Split body, both experimental and placebo

    Investigational medicinal product name
    Lidocaine-epinephrine with gadoteric acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    5 mL of lidocaine-epinephrine 18 mg/mL + 5 μg/mL mixed with gadoteric acid 1,75 mg/mL

    Number of subjects in period 1
    		Overall trial
    Started
    20
    Completed
    20

    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
        Adults (18-64 years)
    		 20 20
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Active nerve block, left side

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For comparison of baseline values with values obtained 1 hours after nerve block performance (post block).

    Subject analysis set title
    Block
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Comparison of side with active nerve block vs. side with sham (placebo) nerve block.

    Subject analysis set title
    Post block
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For comparison of baseline values with values obtained 1 hours after nerve block performance (post block).

    Subject analysis set title
    Sham
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Comparison of side with active nerve block vs. side with sham (placebo) nerve block.

    Primary: Reduction of maximal force of knee extension one hour after iliopsoas plane block compared to baseline

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    End point title
    		 Reduction of maximal force of knee extension one hour after iliopsoas plane block compared to baseline
    End point description
    End point type
    Primary
    End point timeframe
    1 hour after iliopsoas plane block
    End point values
    		 Overall trial Baseline Post block
    Number of subjects analysed
    14
    14
    14
    Units: newton
        number (confidence interval 95%)
    -9.7 (-22 to 3.0)
    354 (299 to 408)
    344 (291 to 397)
    Statistical analysis title
    		 Ttest
    Comparison groups
    Baseline v Post block
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.12
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22
         upper limit
    		 3
    Variability estimate
    Standard deviation
    Dispersion value
    22

    Secondary: Reduction of maximal force of hip adduction one hour after iliopsoas plane block compared to baseline

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    End point title
    		 Reduction of maximal force of hip adduction one hour after iliopsoas plane block compared to baseline
    End point description
    End point type
    Secondary
    End point timeframe
    One hour after iliopsoas plane block compared to baseline
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: newton
        arithmetic mean (confidence interval 95%)
    0.75 (-12 to 14)
    No statistical analyses for this end point

    Secondary: Maximal force of knee extension for active vs. sham block

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    End point title
    		 Maximal force of knee extension for active vs. sham block
    End point description
    End point type
    Secondary
    End point timeframe
    One hour after iliopsoas plane block for
    End point values
    		 Overall trial
    Number of subjects analysed
    14
    Units: newton
        arithmetic mean (confidence interval 95%)
    -8.1 (-18 to 2.5)
    No statistical analyses for this end point

    Secondary: Maximal force of hip adduction for active vs. sham block

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    End point title
    		 Maximal force of hip adduction for active vs. sham block
    End point description
    End point type
    Secondary
    End point timeframe
    One hour after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: newton
        arithmetic mean (confidence interval 95%)
    3.3 (-7.4 to 14)
    No statistical analyses for this end point

    Secondary: Anesthesia for pinprick on the lateral thigh

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    End point title
    		 Anesthesia for pinprick on the lateral thigh
    End point description
    End point type
    Secondary
    End point timeframe
    One hour after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: No. of subjects with anaesthesia
    0
    No statistical analyses for this end point

    Secondary: Anesthesia for pinprick on the proximal medial corner of patella

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    End point title
    		 Anesthesia for pinprick on the proximal medial corner of patella
    End point description
    End point type
    Secondary
    End point timeframe
    One hour after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: No. of subjects with anaesthesia
    0
    No statistical analyses for this end point

    Secondary: Spread of injectate inside the iliopsoas plane

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    End point title
    		 Spread of injectate inside the iliopsoas plane
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    1.0
    No statistical analyses for this end point

    Secondary: Spread of injectate between the iliofemoral ligament and the iliopsoas muscle

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    End point title
    		 Spread of injectate between the iliofemoral ligament and the iliopsoas muscle
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0.33
    No statistical analyses for this end point

    Secondary: Spread of injectate to the interfacial plane between the pectineus and the external obturator muscle

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    End point title
    		 Spread of injectate to the interfacial plane between the pectineus and the external obturator muscle
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Spread of injectate to the superficial surface of the iliopsoas muscle

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    End point title
    		 Spread of injectate to the superficial surface of the iliopsoas muscle
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0.05
    No statistical analyses for this end point

    Secondary: Intraarticular spread of injectate in the hip joint

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    End point title
    		 Intraarticular spread of injectate in the hip joint
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0.05
    No statistical analyses for this end point

    Secondary: Spread of injectate to the posterior side of the hip joint capsule

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    End point title
    		 Spread of injectate to the posterior side of the hip joint capsule
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after ilipsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Spread of injectate to the iliopectineal bursa

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    End point title
    		 Spread of injectate to the iliopectineal bursa
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately after iliopsoas plane block
    End point values
    		 Overall trial
    Number of subjects analysed
    20
    Units: Fraction
        number (not applicable)
    0.28
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 hour after nerve block performance.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    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 trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    General disorders and administration site conditions
    Pain at site of injection
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Muscular pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1

    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
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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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