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    Clinical Trial Results:
    Shamrock versus Lumbar Ultrasound Trident – Ultrasound guided block of the lumbar plexus

    Summary
    EudraCT number
    		 2013-005346-10
    Trial protocol
    		 DK  
    Global end of trial date
    08 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2016
    First version publication date
    23 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUH-TFB-SR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02255591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Thomas Fichtner Bendtsen
    Sponsor organisation address
    Dep. of Anaesthesiology and Intensive Care, Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, DK-8000
    Public contact
    Clinical Trial Info – Shamrock, Thomas Fichtner Bendtsen, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Clinical Trial Info – Shamrock, Thomas Fichtner Bendtsen, +45 51542997, tfb@dadlnet.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
    15 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time for performance of lumbar plexus block in healthy volunteers.
    Protection of trial subjects
    The trial subjects were asked about general well-being and any prior disease and discomfort upon arrival to the trial venue. The trial subjects were monitored with 3-lead electrocardiography, noninvasive pressure, and pulse oximetry from five minutes before the pre-scan to five minutes after completed intervention. During the intervention, the research anaesthesiologist and the assistent communicated with the trail subject reassuring the well-being of the trial subject. Immediately after completed intervention, trial subject discomfort during the procedure was assessed on a numeric rating scale (NRS 0-10).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Feb 2015
    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
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All volunteers were recruited through a Danish website for research volunteers from Feb 9, 2015 to Feb 24, 2015.

    Pre-assignment
    Screening details
    		 22 volunteers were screened and 20 volunteers were included in the study. One of the excluded screened subjects had a knee injury (exclusion criteria). One of the excluded screened subjects was not available for participation on the pre-set dates of the trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Data analyst, Assessor, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Shamrock
    Arm description
    		 All included trial subjects received a lumbar plexus block with the Shamrock technique either on the first or the second trial day (randomized).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidokain-adrenalin SAD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20 ml 2% lidocaine with 0.0005% adrenaline was injected.

    Investigational medicinal product name
    Dotarem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    0.13 ml Dotarem (279.3 mg gadoterate meglumine) was added to the lidocaine-adrenaline prior to injection in order to enhance visualization of the anatomical spread of lidocaine-adrenaline on MRI after the intervention.

    Arm title
    		 Lumbar Ultrasound Trident (LUT)
    Arm description
    		 All included trial subjects received a lumbar plexus block with the LUT technique either on the first or the second trial day (randomized).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lidokain-adrenalin SAD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20 ml 2% lidocaine with 0.0005% adrenaline was injected.

    Investigational medicinal product name
    Dotarem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    0.13 ml Dotarem (279.3 mg gadoterate meglumine) was added to the lidocaine-adrenaline prior to injection in order to enhance visualization of the anatomical spread of lidocaine-adrenaline on MRI after the intervention.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: All trial subjects and observers and analysts of data were blinded. The principal investigator was also the anesthesiologist who performed all lumbar plexus blocks and could therefore not be blinded. The P.I. was not involved in collecting or analyzing data.
    Number of subjects in period 1
    		Shamrock Lumbar Ultrasound Trident (LUT)
    Started
    20
    20
    Completed
    20
    19
    Not completed
    0
    1
         No show (study-unrelated reason)
    -
    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
    		 20 20
    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
        median (inter-quartile range (Q1-Q3))
    		 22.5 (22 to 24.5) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 20 20
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.1 ± 7.8 -
    Height
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 185 (183 to 187) -
    Body Mass Index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25.3 ± 2.9 -

    End points

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    End points reporting groups
    Reporting group title
    Shamrock
    Reporting group description
    		 All included trial subjects received a lumbar plexus block with the Shamrock technique either on the first or the second trial day (randomized).

    Reporting group title
    Lumbar Ultrasound Trident (LUT)
    Reporting group description
    		 All included trial subjects received a lumbar plexus block with the LUT technique either on the first or the second trial day (randomized).

    Primary: Block procedure time

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    End point title
    		 Block procedure time
    End point description
    End point type
    Primary
    End point timeframe
    Assessed after pre-scanning from the time the ultrasound transducer was placed on the skin of the trial subject to the block needle was withdrawn after completed injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: second
        arithmetic mean (standard deviation)
    238 ± 74
    334 ± 156
    Statistical analysis title
    		 Block procedure time
    Statistical analysis description
    Comparison of normal distributed difference between two paired continuous variabels.
    Comparison groups
    Shamrock v Lumbar Ultrasound Trident (LUT)
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0089
    Method
    		 One-sample Student t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -168
         upper limit
    		 -28
    Notes
    [1] - Because this is a statistical test of paired variables, only the 19 subjects that completed both interventions were included in the comparative analysis.

    Secondary: Number of block needle insertions

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    End point title
    		 Number of block needle insertions
    End point description
    The number of block needle insertions was defined as the number of retractions of the block needle followed by advancement regardless of the number of skin insertions.
    End point type
    Secondary
    End point timeframe
    Counted from the start of the block procedure time to the end of injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Number
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    6 (2 to 12)
    No statistical analyses for this end point

    Secondary: Block needle insertion point

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    End point title
    		 Block needle insertion point
    End point description
    The block needle insertion point was estimated as the horizontal distance (cm) from the needle insertion point in the skin to the sagittal midline.
    End point type
    Secondary
    End point timeframe
    Measured immediately after completed injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: cm
        median (inter-quartile range (Q1-Q3))
    3 (3 to 3)
    5 (5 to 6)
    No statistical analyses for this end point

    Secondary: Block needle depth

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    End point title
    		 Block needle depth
    End point description
    The distance from skin to the block needle tip was estimated as the distance (cm) from the block needle insertion point in the skin to the block needle tip gauged by reading of the cm markings on the needle shaft.
    End point type
    Secondary
    End point timeframe
    Measured immediately after completed injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: cm
        median (inter-quartile range (Q1-Q3))
    8 (7 to 8.5)
    7 (6.5 to 7)
    No statistical analyses for this end point

    Secondary: Minimal electrical nerve stimulation

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    End point title
    		 Minimal electrical nerve stimulation
    End point description
    The minimum electrical nerve stimulation level in mA required triggering a response was measured in order to confirm the position of the block needle tip before injection.
    End point type
    Secondary
    End point timeframe
    Assessed immediately prior to injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: mA
        median (inter-quartile range (Q1-Q3))
    0.5 (0.32 to 0.7)
    0.36 (0.32 to 0.46)
    No statistical analyses for this end point

    Secondary: Response on electrical nerve stimulation

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    End point title
    		 Response on electrical nerve stimulation
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed immediately prior to injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        Quadriceps femoris muscle response
    17
    13
        Sartorius muscle response
    1
    3
        Other muscular response
    0
    0
        Paresthesia
    0
    1
        None
    1
    2
    No statistical analyses for this end point

    Secondary: Discomfort during block procedure

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    End point title
    		 Discomfort during block procedure
    End point description
    The trial subject's discomfort during block procedure was assessed on a numeric rating scale (NRS) 0-10, where 0 = no discomfort and 10 = worst possible discomfort.
    End point type
    Secondary
    End point timeframe
    Assessed immediately after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: NRS 0-10
        median (full range (min-max))
    3 (2 to 4)
    4 (3 to 6)
    No statistical analyses for this end point

    Secondary: Change in mean arterial pressure (MAP)

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    End point title
    		 Change in mean arterial pressure (MAP)
    End point description
    End point type
    Secondary
    End point timeframe
    ΔMAP was measured as the change of MAP from the time immediately prior to pre-scanning to 5 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: mmHg
        arithmetic mean (standard deviation)
    1.1 ± 9.4
    -2.7 ± 11.3
    No statistical analyses for this end point

    Secondary: Perineural spread of local anaesthetics

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    End point title
    		 Perineural spread of local anaesthetics
    End point description
    Perineural spread of local anaesthetic was assessed as positive when visual contact between the local anaesthetic and the nerve on MRI was confirmed. Perineural spread was assessed for: anterior rami L1-S1; the femoral, the obturator, and the lateral femoral cutaneous nerves; and the lumbosacral trunk on the ipsilateral side as the block injection.
    End point type
    Secondary
    End point timeframe
    Perineural spread of lidocaine was assessed on MRI scans sampled 15 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        Anteriur ramus L1
    7
    7
        Anterior ramus L2
    19
    15
        Anterior ramus L3
    18
    16
        Anterior ramus L4
    15
    12
        Anterior ramus L5
    3
    6
        Anterior ramus S1
    0
    1
        Femoral nerve
    18
    15
        Obturator nerve
    14
    14
        Lateral femoral cutaneous nerve
    16
    15
        Lumbosacral trunk
    3
    6
    No statistical analyses for this end point

    Secondary: Epidural spread of local anaesthetics

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    End point title
    		 Epidural spread of local anaesthetics
    End point description
    Epidural spread was assessed to be present when circumferential epidural spread of the injectate was observed on MRI and decreased or absent sensation for cold was observed in at least one pair of bilateral dermatomes during the sensory mapping.
    End point type
    Secondary
    End point timeframe
    Epidural spread of local anaesthetics was assessed on MRI sampled 15 minutes after completed intervention and during sensory mapping 45 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        Epidural spread
    0
    1
    No statistical analyses for this end point

    Secondary: Motor block

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    End point title
    		 Motor block
    End point description
    Motor block of the femoral nerve (knee extension), obturator nerve (hip adduction), superior gluteal nerve (hip abduction), and lumbosacral trunk (knee flexion), respectively, was assessed as present when the post-block muscle force of each motion was ≤ 50% of baseline muscle force.
    End point type
    Secondary
    End point timeframe
    Baseline muscle force (mmHg) was assessed on the first trial day prior to intervention. Post-block muscle force (mmHg) was assessed 30 min after completed intervention on each trial day.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        Femoral nerve motor block
    14
    15
        Obturator nerve motor block
    12
    14
        Superior gluteal nerve motor block
    3
    5
        Lumbosacral trunk motor block
    9
    10
    No statistical analyses for this end point

    Secondary: Sensory block - Cold

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    End point title
    		 Sensory block - Cold
    End point description
    Sensory block for cold in the dermatomes T8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for cold was absent.
    End point type
    Secondary
    End point timeframe
    Assessed 45 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        T8
    0
    0
        T9
    0
    0
        T10
    0
    0
        T11
    0
    0
        T12
    0
    0
        L1
    2
    0
        L2
    12
    9
        L3
    16
    15
        L4
    11
    15
        L5
    5
    6
        S1
    14
    14
        S2
    0
    1
        S3
    0
    1
        Lateral femoral cutanous nerve
    14
    9
    No statistical analyses for this end point

    Secondary: Sensory block - Warmth

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    End point title
    		 Sensory block - Warmth
    End point description
    Sensory block for warmth in the dermatomes T8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for warmth was absent.
    End point type
    Secondary
    End point timeframe
    Assessed 45 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        T8
    0
    0
        T9
    0
    0
        T10
    0
    0
        T11
    0
    0
        T12
    0
    0
        L1
    4
    1
        L2
    12
    8
        L3
    15
    15
        L4
    11
    15
        L5
    2
    3
        S1
    10
    9
        S2
    0
    1
        S3
    0
    1
        Lateral femoral cutanous nerve
    15
    10
    No statistical analyses for this end point

    Secondary: Sensory block - Touch

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    End point title
    		 Sensory block - Touch
    End point description
    Sensory block for touch in the dermatomes T8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for touch was absent.
    End point type
    Secondary
    End point timeframe
    Assessed 45 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        T8
    0
    0
        T9
    0
    0
        T10
    0
    0
        T11
    0
    0
        T12
    0
    0
        L1
    4
    0
        L2
    11
    6
        L3
    7
    10
        L4
    9
    12
        L5
    0
    0
        S1
    0
    0
        S2
    0
    0
        S3
    0
    1
        Lateral femoral cutaneous nerve
    16
    8
    No statistical analyses for this end point

    Secondary: Sensory block - Pain

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    End point title
    		 Sensory block - Pain
    End point description
    Sensory block for pinprick (pain) in the dermatomes T8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for pinprick (pain) was absent.
    End point type
    Secondary
    End point timeframe
    Assessed 45 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        T8
    0
    0
        T9
    0
    0
        T10
    0
    0
        T11
    0
    0
        T12
    0
    0
        L1
    4
    0
        L2
    13
    8
        L3
    12
    15
        L4
    9
    13
        L5
    0
    2
        S1
    2
    3
        S2
    0
    2
        S3
    1
    2
        Lateral femoral cutaneous nerve
    13
    9
    No statistical analyses for this end point

    Secondary: Block success

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    End point title
    		 Block success
    End point description
    Block success was assessed as motor block of the femoral and obturator nerves, and sensory block of the lateral femoral cutaneous nerve. Motor block is a proxy marker for sensory block and was assessed as successful when the post-block muscle strength of the femoral and obturator nerves, respectively, was ≤ 50% of baseline muscle force. Success of sensory block of the lateral femoral cutaneous nerve (LFCN) was assessed as present when the sensory for cold and/or pinprick (pain) was absent.
    End point type
    Secondary
    End point timeframe
    Motor block of the femoral and obturator nerves was assessed at 30 min after completed injection. Sensor block of cold and/or pinprick of the lateral femoral cutaneous nerve was assessed at 45 min after completed injection.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: Subjects
        Block success of femoral and obturator nerves
    12
    14
        Block success of femoral, obturator, and LCFN
    7
    7
    No statistical analyses for this end point

    Secondary: Maximum concentration (Cmax) of plasma lidocaine (p-lidocaine)

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    End point title
    		 Maximum concentration (Cmax) of plasma lidocaine (p-lidocaine)
    End point description
    End point type
    Secondary
    End point timeframe
    Cmax of p-lidocaine was assessed in blood sampled at 0, 5, 10, 20, 40, 60, and 90 minutes after intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: μg*ml-1
        arithmetic mean (standard deviation)
    1.45 ± 0.35
    1.4 ± 0.36
    No statistical analyses for this end point

    Secondary: Time to Cmax p-lidocaine

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    End point title
    		 Time to Cmax p-lidocaine
    End point description
    End point type
    Secondary
    End point timeframe
    Time to Cmax was estimated in the period 0-90 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    60 (60 to 60)
    60 (40 to 60)
    No statistical analyses for this end point

    Secondary: Lidocaine concentration-area under the curve

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    End point title
    		 Lidocaine concentration-area under the curve
    End point description
    End point type
    Secondary
    End point timeframe
    Assessed in the period 0-90 minutes after completed intervention.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: μg*min*ml-1
        arithmetic mean (standard deviation)
    102 ± 25
    102 ± 27
    No statistical analyses for this end point

    Secondary: Cost-effectiveness

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    End point title
    		 Cost-effectiveness
    End point description
    Cost-effectiveness of the interventions was estimated as the difference in mean marginal cost for the Shamrock vs. the LUT technique.
    End point type
    Secondary
    End point timeframe
    Calculated in the end of the data analysis after last subject last visit.
    End point values
    		 Shamrock Lumbar Ultrasound Trident (LUT)
    Number of subjects analysed
    20
    19
    Units: USD
        number (not applicable)
    0
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Continuous assessment of adverse events from the start of pre-scanning until the discharge after intervention on the trial day. All trial subjects were urged to self-report any adverse events after discharge.
    Adverse event reporting additional description
    Regular assessment of adverse events from the start of pre-scanning until the end of observation. All trial subjects were systematically asked about any adverse events by the time of discharge. All trial subjects were urged to self-report any adverse events after discharge - both between the trial days and after the last trial day.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Shamrock lumbar plexus block
    Reporting group description
    		 -

    Reporting group title
    Lumbar Ultrasound Trident lumbar plexus block
    Reporting group description
    		 -

    Serious adverse events
    		 Shamrock lumbar plexus block Lumbar Ultrasound Trident lumbar plexus block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Shamrock lumbar plexus block Lumbar Ultrasound Trident lumbar plexus block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 19 (10.53%)
    Vascular disorders
    Phlebitis superficial
    Additional description: Superficial phlebitis on the site of the i.v. access used for blood sampling.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
    Additional description: Short and temporary sensation of palpitations related to injection of lidocaine-adrenaline.
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Skin rash where plaster had been used to fix i.v. access used for blood sampling and sterile surgical cover, respectively.
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1

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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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