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    Clinical Trial Results:
    Minimal local anaesthetic volumes for sciatic nerve blockade: A clinical evaluation of ED99 volumes

    Summary
    EudraCT number
    		 2012-005075-14
    Trial protocol
    		 AT  
    Global end of trial date
    09 Sep 2014

    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

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    Trial identification
    Sponsor protocol code
    1.0
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    Daniela Marhofer, Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmed und Schm, +43 1404004100, daniela.marhofer@meduniwien.ac.at
    Scientific contact
    Daniela Marhofer, Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmed und Schm, +43 1404004100, daniela.marhofer@meduniwien.ac.at
    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
    02 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to investigate if the previously evaluated ED99 for ultrasound guided peripheral nerve blockade is transferable for surgical anaesthesia and analgesia.
    Protection of trial subjects
    + Full clinical evaluation of the patients before inclusion in study + Perioperative continuous monitoring of vital parameters (blood pressure, ECG, oxygen saturation) + Ultrasound guided blockade of the sciatic nerve (real-time) + One week after the study, all patients were examined for signs of infection or haematoma.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 2013
    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
    Austria: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 After ethical approval, all patients were informed about the nature, scope, procedures, and associated risks of the study. The patients were undergoing foot surgery at the Department of Plastic and Reconstructive Surgery (Medical University of Vienna)

    Pre-assignment
    Screening details
    		 Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.

    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

    Arms
    Arm title
    		 Ropivacain
    Arm description
    		 nclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Epidural use
    Dosage and administration details
    0,75% extra-epineural Injektion

    Number of subjects in period 1
    		Ropivacain
    Started
    15
    Completed
    14
    Not completed
    1
         Lost to follow-up
    1

    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
    		 15 15
    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)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    Ropivacain
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.

    Subject analysis sets values
    		 Ropivacain
    Number of subjects
    14
    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)
    15
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    10

    End points

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    End points reporting groups
    Reporting group title
    Ropivacain
    Reporting group description
    		 nclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.

    Subject analysis set title
    Ropivacain
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.

    Primary: surgical analgesia

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    End point title
    		 surgical analgesia [1]
    End point description
    End point type
    Primary
    End point timeframe
    Sensory and motor block time was defined as the time from performing the block until pinprick < 10% and motor score = 0 (in comparison with the contralateral side)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Sensory and motor block time was defined as the time from performing the block until pinprick < 10% and motor score = 0 (in comparison with the contralateral side)
    End point values
    		 Ropivacain Ropivacain
    Number of subjects analysed
    15
    15
    Units: 14
    4
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From beginning of the study when performing the block for the operation until 1 week after the intervention/operation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: There was no Adverse events in this Study

    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/25644578
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