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    Clinical Trial Results:
    Does perineural dexmedetomidine prolong the duration of an ulnar nerve block when controlling for possible systemic effects? - a randomized, blinded, placebo controlled, paired trial in healthy volunteers

    Summary
    EudraCT number
    		 2016-004883-20
    Trial protocol
    		 DK  
    Global end of trial date
    30 Sep 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SM1-JH-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03222323
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ZUH, Køge
    Sponsor organisation address
    Lykkebækvej 1, Koege, Denmark,
    Public contact
    Jakob Hessel Andersen, Zealand University Hospital, +45 60610666, Jahea@regionsjaelland.dk
    Scientific contact
    Jakob Hessel Andersen, Zealand University Hospital, +45 60610666, Jahea@regionsjaelland.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
    01 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the trial is to investigate whether dexmedetomidine used as an adjuvant to ropivacaine prolongs block duration compared to ropivacaine alone, and whether block duration is affected by the mode of dexmedetomidine administration.
    Protection of trial subjects
    Ropivacaine is a well-known local anesthetic registered for perineural use, and is given within recommended doses. Dexmedetomidine is used systemically for sedation in the ICU and for procedures in Eu-rope. Dexmedetomidine is not approved for perineural administration, but is well de-scribed in the literature as an adjuvant for peripheral nerve blocks. No overrepresentation of nerve injury has been proven in studies using dexmedetomidine perineurally. There are no existing reports of permanent nerve damage in studies employing perineural dex-medetomidine, and several in vitro studies on rats did not find increased risk of nerve in-flammation/damage when dexmedetomidine was co-administered with ropivacaine com-pared to ropivacaine alone. It is therefore our opinion that side effects and risks associat-ed with participation in this trial are minimal. The nerve blocks are performed using ultrasound guidance minimizing the risk of compli-cations. The nerve blocks are performed by one of two anesthesiologists trained in ultra-sound-guided nerve blocks.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2017
    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: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants will be recruited from the news bulletin for medical students ”MOK” in Copenhagen, Facebook groups for medical students and from Forsoegsperson.dk.

    Pre-assignment
    Screening details
    		 The volunteers will be screened in a telephone interview. A copy of the participant trial information will be send prior to the trial date. They will be informed about the possibility of bringing an external assessor. On the trial date, participants will receive oral infor-mation by the principal investigator, in a closed room without interruptions

    Period 1
    Period 1 title
    Dexmedetomidine day
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Blinding procedure, packaging and labeling The trial is conducted in a blinded, randomized fashion. The randomization is done by a computer generated randomization list, generated by the Skanderborg pharmacy, who according to the randomization manufactures two boxes for each participant. The boxes contain the trial medication, one box for each of the two trial days. The trial medicine will be packed and labelled by Skanderborg Pharmacy according to the applicable rules.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Perineural treatment
    Arm description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5 % + 1,0 mL dex-medetomidine 100 μg/ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    100ug

    Arm title
    		 Systemic treatment
    Arm description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5 % + 1,0mL isotonic saline (systemic dexmedetomidine from the opposite arm)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection, Solution for injection/infusion
    Routes of administration
    Perineural use, Not mentioned
    Dosage and administration details
    100ug absorbed and redistributed from opposite arm

    Number of subjects in period 1
    		Perineural treatment Systemic treatment
    Started
    22
    22
    Completed
    22
    22
    Period 2
    Period 2 title
    Placebo day
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The trial is conducted in a blinded, randomized fashion. The randomization is done by a computer generated randomization list, generated by the Skanderborg pharmacy, who according to the randomization manufactures two boxes for each participant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo treatment
    Arm description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5% + 1,0 mL isotonic saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    1 ml coadministered perineurally

    Arm title
    		 High-dose ropivacaine
    Arm description
    		 Ulnar nerve block with 4 ml ropivacaine 0,75 % + 1,0mL isotonic saline
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ropivavcaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    7.5mg/ml 4 ml perineurally

    Number of subjects in period 2
    		Placebo treatment High-dose ropivacaine
    Started
    22
    22
    Completed
    22
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dexmedetomidine day
    Reporting group description
    		 -

    Reporting group values
    		 Dexmedetomidine day Total
    Number of subjects
    		 22 22
    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)
    		 24 ( 2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Perineural treatment
    Reporting group description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5 % + 1,0 mL dex-medetomidine 100 μg/ml

    Reporting group title
    Systemic treatment
    Reporting group description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5 % + 1,0mL isotonic saline (systemic dexmedetomidine from the opposite arm)
    Reporting group title
    Placebo treatment
    Reporting group description
    		 Ulnar nerve block with 4 ml ropivacaine 0,5% + 1,0 mL isotonic saline

    Reporting group title
    High-dose ropivacaine
    Reporting group description
    		 Ulnar nerve block with 4 ml ropivacaine 0,75 % + 1,0mL isotonic saline

    Primary: Duration of sensory nerve block (Mechanical discrimination )

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    End point title
    		 Duration of sensory nerve block (Mechanical discrimination )
    End point description
    End point type
    Primary
    End point timeframe
    0-36 h
    End point values
    		 Perineural treatment Systemic treatment Placebo treatment High-dose ropivacaine
    Number of subjects analysed
    22
    22
    22
    22
    Units: hours
        arithmetic mean (confidence interval 95%)
    14.4 (13.1 to 15.6)
    9.2 (8.6 to 9.8)
    7.1 (6.6 to 7.6)
    7.8 (7.3 to 8.3)
    Statistical analysis title
    		 Paired T test
    Comparison groups
    Perineural treatment v Placebo treatment
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Onset of block (mechanical discrimination)

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    End point title
    		 Onset of block (mechanical discrimination)
    End point description
    End point type
    Secondary
    End point timeframe
    0-120 minutes
    End point values
    		 Perineural treatment Systemic treatment Placebo treatment High-dose ropivacaine
    Number of subjects analysed
    22
    22
    22
    22
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    13 (10 to 16)
    12 (10 to 15)
    13 (10 to 15)
    12 (8 to 16)
    No statistical analyses for this end point

    Secondary: Duration of block (temperature discrimination)(h)

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    End point title
    		 Duration of block (temperature discrimination)(h)
    End point description
    End point type
    Secondary
    End point timeframe
    0-36 h
    End point values
    		 Perineural treatment Systemic treatment Placebo treatment High-dose ropivacaine
    Number of subjects analysed
    22
    22
    22
    22
    Units: hours
        arithmetic mean (confidence interval 95%)
    14 (13.1 to 15)
    9.1 (8.6 to 9.7)
    7.5 (6.9 to 8.1)
    8.1 (7.5 to 8.6)
    Statistical analysis title
    		 Paired T test
    Comparison groups
    Perineural treatment v Placebo treatment
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Paired T-test
    Comparison groups
    Systemic treatment v Placebo treatment
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Non- inferiority
    Comparison groups
    Perineural treatment v Systemic treatment
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Paired T test
    Comparison groups
    Perineural treatment v High-dose ropivacaine
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Paired T test
    Comparison groups
    Systemic treatment v High-dose ropivacaine
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Duration of block-analgesia (PDTH) (h)

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    End point title
    		 Duration of block-analgesia (PDTH) (h)
    End point description
    End point type
    Secondary
    End point timeframe
    0-36 h
    End point values
    		 Perineural treatment Systemic treatment Placebo treatment High-dose ropivacaine
    Number of subjects analysed
    22
    22
    22
    22
    Units: hours
        arithmetic mean (confidence interval 95%)
    13.6 (12.7 to 14.6)
    9.3 (8.5 to 10)
    7.6 (7.1 to 8.1)
    8 (7.5 to 8.7)
    No statistical analyses for this end point

    Secondary: Duration of motor block (MVIC) (h)

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    End point title
    		 Duration of motor block (MVIC) (h)
    End point description
    End point type
    Secondary
    End point timeframe
    0-36 h
    End point values
    		 Perineural treatment Systemic treatment Placebo treatment High-dose ropivacaine
    Number of subjects analysed
    22
    22
    22
    22
    Units: hours
        arithmetic mean (confidence interval 95%)
    15.4 (14.2 to 16.6)
    9.8 (9.1 to 10.5)
    7.4 (6.9 to 8.0)
    8.1 (7.5 to 8.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-36h
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICH
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Bradycardia/hypotension
    Reporting group description
    		 -

    Serious adverse events
    		 Bradycardia/hypotension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (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
    		 Bradycardia/hypotension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    Cardiac disorders
    bradycardia/hypotension
    Additional description: 1 participant experienced this event
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2017
    Changed statistical plan from equality to non-inferiority trial Changed primary outcome to duration of nerve block measured by mechanical discrimination.

    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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