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    Clinical Trial Results:
    Does perineural dexamethasone increase the duration of an ulnar nerve block when controlling for systemic effects? A randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers

    Summary
    EudraCT number
    		 2020-004242-10
    Trial protocol
    		 DK  
    Global end of trial date
    15 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2022
    First version publication date
    15 May 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MM1-2020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04817982
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Lykkebækvej 1, Køge, Denmark, 4600
    Public contact
    Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark, mmaag@regionsjaelland.dk
    Scientific contact
    Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark, mmaag@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
    02 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if perineural dexamethasone increases the duration of an ulnar nerve block when controlling for the systemic effects of dexamethasone. We will primarily assess the duration of the ulnar nerve block by temperature discrimination.
    Protection of trial subjects
    Healthy volunteers had one peripheral venous cathether placed in their forearm prior to block performence. Healthy volunteers were monitored for 30 minutes after block performance using 5-lead electrocardiography, continuous peripheral saturation measurement, and non-invasive blood pressure measurement every 5 minutes. The follow-up related to duration of the ulnar nerve blocks were conducted by health care professionals in a hospital setting. All participants were followed-up until complete block cessation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 2021
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled in the Capital and Zealand Regions of Denmark between 7 April 2021 and 15 May 2021.

    Pre-assignment
    Screening details
    		 Important exclusion criteria were allergy to study medication, use of corticosteroids or prescription analgesics, alcohol or drug abuse, cardiovascular disease, and diabetes. Eighteen healthy volunteers aged 18 to 65 were screened for inclusion. One refused to participate and one were excluded due to concomitant corticosteroid therapy.

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    Trial day one/two (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Research nurses, not otherwise involved in the trial, prepared trial medication in identical syringes with identical appearing medicine and identical volume. There were no incidences of unblinding. Participants were randomly allocated to receive perineural/systemic dexamethasone on either day 1 or 2 and on the other day to receive lidocaine/placebo.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Perineural dexamethasone
    Arm description
    		 In this arm, ulnar nerve blocks were performed with 3ml of 5mg/ml bupivacaine + 1ml of 4mg/ml perineural dexamethasone + 1ml saline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    3ml of 5mg/ml bupivacaine

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    1ml of 4mg/ml dexamethasone

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    1ml of isotonic saline.

    Arm title
    		 Systemic dexamethasone
    Arm description
    		 Perineural dexamethasone is added on the opposite site of this arm. Some of the perineurally administered dexamethasone would be absorbed and exert systemic effects on the 'systemic dexamethasone' arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    3ml of 5mg/ml bupivacaine

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2ml of isotonic saline.

    Arm title
    		 Lidocaine
    Arm description
    		 Lidocaine 20 mg/ml was added to bupivacaine 5mg/ml
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    3ml of 5mg/ml bupivacaine

    Investigational medicinal product name
    Lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2ml of 20mg/ml lidocaine

    Arm title
    		 Placebo
    Arm description
    		 Saline was added to bupivacaine.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    3ml of 5mg/ml bupivacaine

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2ml of isotonic saline.

    Number of subjects in period 1
    		Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Started
    16
    16
    16
    16
    Completed
    16
    16
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trial day one/two
    Reporting group description
    		 -

    Reporting group values
    		 Trial day one/two Total
    Number of subjects
    		 16 16
    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)
    		 16 16
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.6 ( 3.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 7 7
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 178 ( 9 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 75 ( 15 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 24 ( 4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Perineural dexamethasone
    Reporting group description
    		 In this arm, ulnar nerve blocks were performed with 3ml of 5mg/ml bupivacaine + 1ml of 4mg/ml perineural dexamethasone + 1ml saline.

    Reporting group title
    Systemic dexamethasone
    Reporting group description
    		 Perineural dexamethasone is added on the opposite site of this arm. Some of the perineurally administered dexamethasone would be absorbed and exert systemic effects on the 'systemic dexamethasone' arm.

    Reporting group title
    Lidocaine
    Reporting group description
    		 Lidocaine 20 mg/ml was added to bupivacaine 5mg/ml

    Reporting group title
    Placebo
    Reporting group description
    		 Saline was added to bupivacaine.

    Primary: Duration of the sensory block as measured by temperature discrimination

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    End point title
    		 Duration of the sensory block as measured by temperature discrimination
    End point description
    Participants were stimulated with an alcohol swab in the hypothenar area. When the alcohol swab was identified as cold, the block was defined as having cessated.
    End point type
    Primary
    End point timeframe
    Every 30 minutes from block onset until a cold swab feels cold again.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    706 (656 to 756)
    677 (617 to 736)
    452 (373 to 530)
    640 (576 to 705)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Statistical analysis description
    We performed paired t-test for the comparisons of perineural dexamethasone versus placebo, systemic dexamethasone versus placebo, and lidocaine versus placebo.
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.005
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23
         upper limit
    		 108
    Variability estimate
    Standard deviation
    Notes
    [1] - Paired t-test
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Systemic dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.26
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30
         upper limit
    		 103
    Variability estimate
    Standard deviation
    Notes
    [2] - Paired t-test
    Statistical analysis title
    		 Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -189
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -243
         upper limit
    		 -135
    Variability estimate
    Standard deviation
    Notes
    [3] - Paired t-test

    Secondary: Duration of the sensory block measured by mechanical discrimination

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    End point title
    		 Duration of the sensory block measured by mechanical discrimination
    End point description
    The participants were stimulated in the hypothenar area with a needle. The block was defined as having cessated when a needle felt sharp again.
    End point type
    Secondary
    End point timeframe
    Measured every 30 minutes from block onset until a needle felt sharp again.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: minutes
        arithmetic mean (confidence interval 95%)
    612 (548 to 677)
    624 (559 to 689)
    374 (321 to 427)
    604 (523 to 685)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.79
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -57
         upper limit
    		 73
    Variability estimate
    Standard deviation
    Notes
    [4] - Paired t-test
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.79
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -57
         upper limit
    		 73
    Variability estimate
    Standard deviation
    Notes
    [5] - Paired t-test
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Placebo v Systemic dexamethasone
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.56
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51
         upper limit
    		 91
    Variability estimate
    Standard deviation
    Notes
    [6] - Paired t-test
    Statistical analysis title
    		 Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -230
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -290
         upper limit
    		 -170
    Variability estimate
    Standard deviation
    Notes
    [7] - Paired t-test

    Secondary: Duration of the sensory block measured by pain during tonic heat stimulatiom

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    End point title
    		 Duration of the sensory block measured by pain during tonic heat stimulatiom
    End point description
    Participants were stimulated every 30 minutes with a probe heated to 45 degrees Celcius for 30 seconds. The block was defined as having cessated when stimulation elicited a painful response again.
    End point type
    Secondary
    End point timeframe
    Every 30 minutes from block onset until stimulation with a 45 degrees Celcius probe in the hypothenar area elicited pain again.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: minutes
        arithmetic mean (confidence interval 95%)
    651 (586 to 715)
    661 (606 to 717)
    398 (335 to 462)
    578 (493 to 664)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14
         upper limit
    		 130
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Placebo v Systemic dexamethasone
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 154
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -180
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -237
         upper limit
    		 -124
    Variability estimate
    Standard deviation

    Secondary: Duration of the motor block measured by fifth finger abduction

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    End point title
    		 Duration of the motor block measured by fifth finger abduction
    End point description
    Participants' hands were immobilised allowing only for fifth finger abduction. The strength during abduction was assessed using the modified Bromage scale. The motor block was defined as cessated when fifth finger abduction reached a Bromage score of 4 or the participant indicated normal strength.
    End point type
    Secondary
    End point timeframe
    Measured every 30 minutes from block onset until fifth finger abduction reached a Bromage score of 4 or the participant indicated normal strength in the fifth finger.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: minutes
        arithmetic mean (confidence interval 95%)
    613 (564 to 662)
    652 (587 to 716)
    391 (337 to 445)
    603 (537 to 669)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37
         upper limit
    		 57
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Placebo v Systemic dexamethasone
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20
         upper limit
    		 118
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Copy of Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -212
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -265
         upper limit
    		 -159
    Variability estimate
    Standard deviation

    Secondary: Onset of the sensory block measured by temperature discrimination

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    End point title
    		 Onset of the sensory block measured by temperature discrimination
    End point description
    The participants were stimulated in their hypothenar area using an alcohol swab. Block onset was defined as when an alcohol swab no longer felt cold.
    End point type
    Secondary
    End point timeframe
    Measured every minute until an alcohol swab no longer felt cold.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: minutes
        arithmetic mean (confidence interval 95%)
    2.8 (2.1 to 3.6)
    2.7 (1.6 to 3.8)
    2.3 (1.6 to 3.0)
    3.1 (2.1 to 4.1)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.8
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Placebo v Systemic dexamethasone
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.9
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.1
    Variability estimate
    Standard deviation

    Secondary: Onset of the motor block measured by fifth finger abduction

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    End point title
    		 Onset of the motor block measured by fifth finger abduction
    End point description
    The participants' hands were immobilised allowing only for fifth finger abduction. The motor block onset was assessed every 1 minute until the fifth finger abduction reached a Bromage score of 0.
    End point type
    Secondary
    End point timeframe
    Measured every minute until fifth finger abduction reached a Bromage score of 0.
    End point values
    		 Perineural dexamethasone Systemic dexamethasone Lidocaine Placebo
    Number of subjects analysed
    16
    16
    16
    16
    Units: minutes
        arithmetic mean (confidence interval 95%)
    5.5 (3.4 to 7.6)
    4.5 (3.0 to 6.0)
    4.2 (2.9 to 5.5)
    5.9 (4.0 to 7.7)
    Statistical analysis title
    		 Paired t-test arm 1 versus arm 4
    Comparison groups
    Perineural dexamethasone v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.79
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 2.6
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 2 versus arm 4
    Comparison groups
    Placebo v Systemic dexamethasone
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 1
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Paired t-test arm 3 versus arm 4
    Comparison groups
    Placebo v Lidocaine
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Paired t-test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.4
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From block performance until 24 hours after completion of each of the two trial days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    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: None of the healthy volunteers experienced non-serious adverse events during follow-up.

    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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