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    Clinical Trial Results:
    DEXMEDETOMIDINE FOR PERIPHERAL NERVE BLOCKADE: A DOSE-FINDING STUDY IN VOLUNTEERS

    Summary
    EudraCT number
    		 2013-003790-10
    Trial protocol
    		 AT  
    Global end of trial date
    24 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2016
    First version publication date
    25 Feb 2016
    Other versions
    Summary report(s)
    		 Publication_EudraCT 2013-003790-10

    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, Vienna, Austria, 1090
    Public contact
    Maya Keplinger, Medical University of Vienna, 0043 1404004100, maya.keplinger@meduniwien.ac.at
    Scientific contact
    Maya Keplinger, Medical University of Vienna, 0043 1404004100, maya.keplinger@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
    18 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Duration of sensory block of the ulnar nerve
    Protection of trial subjects
    Subject were during the trial continuously under the supervision of a physician or an experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Nov 2013
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruitet by use of the data base of the Clinical Pharmacology, Medical University Vienna.

    Pre-assignment
    Screening details
    		 Check of the In- and Exclusion criteria, Physical examination, Vital signs, Laboratory assessment

    Pre-assignment period milestones
    Number of subjects started
    		 24
    Number of subjects completed
    		 24

    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, Data analyst
    Blinding implementation details
    The study drugs will be prepared by a study nurse outside the area where the blocks are performed. Both the anaesthetist and the volunteers are not informed about the adjuvants for LA for ulnar nerve blockade. All sensory tests will be performed by a study physician not otherwise involved in the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group R
    Arm description
    		 Group R: 3 ml ropivacaine without adjuvants
    Arm type
    		 active control

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5mg Ropivacaine perineural as single dose

    Arm title
    		 Group RD50
    Arm description
    		 Group RD50: 22.5 mg ropivacaine mixed with 50 µg dexmedetomidine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 50 µg dexmedetomidine perineural as a single dose

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    29332990
    Other name
    Dexdor
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 50 µg dexmedetomidine perineural as a single dose

    Arm title
    		 Group RD100
    Arm description
    		 Group RD100: 22.5 mg ropivacaine mixed with 100 µg dexmedetomidine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 100 µg dexmedetomidine perineural as a single dose

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    29332990
    Other name
    Dexdor
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 100 µg dexmedetomidine perineural as a single dose

    Arm title
    		 Group RD150
    Arm description
    		 Group RD150: 22.5 mg ropivacaine mixed with 150 µg dexmedetomidine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 150 µg dexmedetomidine perineural as a single dose

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    29332990
    Other name
    Dexdor
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    Administration of 22.5 mg ropivacaine mixed with 150 µg dexmedetomidine perineural as a single dose

    Number of subjects in period 1
    		Group R Group RD50 Group RD100 Group RD150
    Started
    6
    6
    6
    6
    Completed
    6
    6
    6
    6

    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
    		 24 24
    Age categorical
    18 to 45 years of age
    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)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    18 to 45
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 24 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Group R
    Reporting group description
    		 Group R: 3 ml ropivacaine without adjuvants

    Reporting group title
    Group RD50
    Reporting group description
    		 Group RD50: 22.5 mg ropivacaine mixed with 50 µg dexmedetomidine

    Reporting group title
    Group RD100
    Reporting group description
    		 Group RD100: 22.5 mg ropivacaine mixed with 100 µg dexmedetomidine

    Reporting group title
    Group RD150
    Reporting group description
    		 Group RD150: 22.5 mg ropivacaine mixed with 150 µg dexmedetomidine

    Subject analysis set title
    main
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects who where treated according to the protocol

    Primary: duration of complete sensory block to pinprick and time

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    End point title
    		 duration of complete sensory block to pinprick and time
    End point description
    End point type
    Primary
    End point timeframe
    full period
    End point values
    		 Group R Group RD50 Group RD100 Group RD150 main
    Number of subjects analysed
    6
    6
    6
    6
    Units: hours
        number (not applicable)
    8.7
    16.4
    20.4
    21.2
    24
    Statistical analysis title
    		 Descriptive evaluation of four different groups
    Statistical analysis description
    the study was designed as mainly descriptive evaluation of four different study groups. As primary and secondary outcomes consist of time-to-event data, logrank test analyses were performed and the dose-dependency of dexmedetomidine was evaluated with the logrank test for trend. The dose-dependent effects of dexmedetomidine on sedation scores were analysed using the Cuzick trend test. Other data were analysed using a Kruskal–Wallis one-way analysis and unpaired Mann–Whitney U-posthoc test
    Comparison groups
    Group R v Group RD50 v Group RD100 v Group RD150
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - As primary and secondary outcomes consist of time-to-event data, logrank test analyses were performed and the dose-dependency of dexmedetomidine was evaluated with the logrank test for trend. The dose-dependent effects of dexmedetomidine on sedation scores were analysed using the Cuzick trend test. Other data were analysed using a Kruskal–Wallis one-way analysis and unpaired Mann–Whitney U-posthoc tests with Bonferroni–Holm correction. IBM SPSS Statistics 20.0 and GraphPad Prism were used for an

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from 02.Dec.2013 to 24.Dec.2013
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    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 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    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
    21 / 24 (87.50%)
    Vascular disorders
    Hypotension
    Additional description: intermittend Hypotension
         subjects affected / exposed
    21 / 24 (87.50%)
         occurrences all number
    21
    Cardiac disorders
    Sinus bradycardia
    Additional description: intermittend Sinus bradycardia
         subjects affected / exposed
    9 / 24 (37.50%)
         occurrences all number
    9
    Nervous system disorders
    Hypoaesthesia
    Additional description: Hypoaesthesia at nerv block site after the end of the study day
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    Mucosal dryness
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    7

    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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