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    Clinical Trial Results:
    Pilot-Study comparing analgosedation concepts during placement of regional anaesthesia with either fentanyl, remifentanil, clonidine, EMLA-Patch or placebo in regard of patient's wellbeing, pain and satisfaction. A randomised, doubleblind, controlled pilot-study.

    Summary
    EudraCT number
    		 2019-000700-14
    Trial protocol
    		 AT  
    Global end of trial date
    18 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2023
    First version publication date
    23 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04026074
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Neue Stiftingtalstraße 6, Graz, Austria, 8010
    Public contact
    Division of general anaesthesia, Medical University of Graz, gregor.schittek@medunigraz.at
    Scientific contact
    Division of general anaesthesia, Medical University of Graz, gregor.schittek@medunigraz.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
    29 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To specify the best analgosedation technic during placement of regional anaesthesia from the patients view (primary endpoint is pain intensity during placement of the regional anaesthesia).
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jul 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
    Austria: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    33
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between July and October 2019.

    Pre-assignment
    Screening details
    		 After informed consent 50 patients were randomized into one of five study arms.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Remifentanil
    Arm description
    		 Remifentanil infusion with a rate of 6 to 9 µg kg-1 h-1
    Arm type
    		 Experimental

    Investigational medicinal product name
    remifentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Remifentanil infusion with a rate of 6 to 9 µg kg-1 h-1

    Arm title
    		 Fentanyl
    Arm description
    		 intravenous bolus of 100 µg (body weight above 50 kg) or 50µg (body weight below 50 kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fentanyl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    intravenous bolus of 100 µg (body weight above 50 kg) or 50µg (body weight below 50 kg)

    Arm title
    		 Clonidine
    Arm description
    		 clonidine intravenous bolus of 150 µg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    clonidine intravenous bolus of 150 µg

    Arm title
    		 Lidocaine/Prilocaine
    Arm description
    		 Lidocaine/Prilocaine topical cream 1.5g/10cm2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine/Prilocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Lidocaine/Prilocaine topical cream 1.5g/10cm2; administered at least 30 minutes before skin puncture

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion, Cream
    Routes of administration
    Cutaneous use, Intravenous use
    Dosage and administration details
    Patients were administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)

    Number of subjects in period 1
    		Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo
    Started
    9
    12
    9
    12
    8
    Completed
    9
    12
    9
    12
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Remifentanil
    Reporting group description
    		 Remifentanil infusion with a rate of 6 to 9 µg kg-1 h-1

    Reporting group title
    Fentanyl
    Reporting group description
    		 intravenous bolus of 100 µg (body weight above 50 kg) or 50µg (body weight below 50 kg)

    Reporting group title
    Clonidine
    Reporting group description
    		 clonidine intravenous bolus of 150 µg

    Reporting group title
    Lidocaine/Prilocaine
    Reporting group description
    		 Lidocaine/Prilocaine topical cream 1.5g/10cm2

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo Total
    Number of subjects
    		 9 12 9 12 8 50
    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)
    		 58 ± 19.8 61 ± 18 47 ± 21.6 55 ± 19.4 60 ± 18 -
    Gender categorical
    Units: Subjects
        Female
    		 5 7 6 5 6 29
        Male
    		 4 5 3 7 2 21

    End points

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    End points reporting groups
    Reporting group title
    Remifentanil
    Reporting group description
    		 Remifentanil infusion with a rate of 6 to 9 µg kg-1 h-1

    Reporting group title
    Fentanyl
    Reporting group description
    		 intravenous bolus of 100 µg (body weight above 50 kg) or 50µg (body weight below 50 kg)

    Reporting group title
    Clonidine
    Reporting group description
    		 clonidine intravenous bolus of 150 µg

    Reporting group title
    Lidocaine/Prilocaine
    Reporting group description
    		 Lidocaine/Prilocaine topical cream 1.5g/10cm2

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Pain at puncture (categorised)

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    End point title
    		 Pain at puncture (categorised)
    End point description
    End point type
    Primary
    End point timeframe
    during placement of the regional anaesthesia
    End point values
    		 Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo
    Number of subjects analysed
    9
    12
    9
    12
    8
    Units: Number of patients
        light pain (1 to 2)
    7
    5
    1
    6
    3
        medium or strong pain (from 3)
    2
    7
    8
    6
    5
    Statistical analysis title
    		 Pain at puncture (categorised)
    Comparison groups
    Remifentanil v Fentanyl v Clonidine v Lidocaine/Prilocaine v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.08
    Method
    		 Chi-squared
    Confidence interval

    Primary: Pain at puncture

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    End point title
    		 Pain at puncture
    End point description
    Numeric rating scale; 10 indicating the highest pain score
    End point type
    Primary
    End point timeframe
    during placement of the regional anaesthesia
    End point values
    		 Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo
    Number of subjects analysed
    9
    12
    9
    12
    8
    Units: Units on numeric rating scale
        median (inter-quartile range (Q1-Q3))
    2.00 (1.5 to 3.0)
    3.00 (2.0 to 4.75)
    4.0 (3.0 to 5.0)
    2.5 (1.25 to 4.0)
    3.00 (2.0 to 4.5)
    Statistical analysis title
    		 Pain at puncture
    Comparison groups
    Remifentanil v Fentanyl v Clonidine v Lidocaine/Prilocaine v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.172
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Complication rate

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    End point title
    		 Complication rate
    End point description
    End point type
    Secondary
    End point timeframe
    1 day
    End point values
    		 Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo
    Number of subjects analysed
    9
    12
    9
    12
    8
    Units: Number of complicatons
        Number of complications
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Wellbeing

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    End point title
    		 Wellbeing
    End point description
    Wellbeing assessment during placement of the regional anaesthesia was assessed with the anaesthesiological questionnaire (ANP). ANP is a self-rating method for the assessment of postoperative complaints, patient wellbeing and satisfaction. The rating scales from 0 to 3, with 0="none" and 3="strongly"). Higher wellbeing values represent a better outcome.
    End point type
    Secondary
    End point timeframe
    1 day after surgery
    End point values
    		 Remifentanil Fentanyl Clonidine Lidocaine/Prilocaine Placebo
    Number of subjects analysed
    9
    12
    9
    12
    8
    Units: Number of patients
        None
    0
    0
    0
    1
    0
        Some
    1
    3
    0
    3
    1
        quite
    6
    8
    9
    7
    6
        Strong
    2
    0
    0
    1
    1
    Statistical analysis title
    		 Wellbeing
    Comparison groups
    Remifentanil v Fentanyl v Clonidine v Lidocaine/Prilocaine v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.535
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from inclusion to end of study for the respective patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    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: The follow-up period per patient for this study was very short. No complications or adverse effects were observed during this time.

    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
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