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    Clinical Trial Results:
    Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery

    Summary
    EudraCT number
    2014-004207-78
    Trial protocol
    DK  
    Global end of trial date
    16 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Jul 2017
    First version publication date
    16 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ProtokolSB1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02346110
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Nørrebrogade 44, Aarhus C, Denmark, 8000
    Public contact
    Department of Anesthesia and Intensive Care, Aarhus University Hospital, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Department of Anesthesia and Intensive Care , Aarhus University Hospital, +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
    29 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to investigate whether addition of the adjuvant dexamethasone to bupivacaine-adrenaline can prolong the analgesic effect of the saphenous block compared to plain bupivacaine-adrenaline in patients after major ankle and hind foot surgery.
    Protection of trial subjects
    Patients received a PCA pump with morphine to provide instant pain relief at bolus request. Patients were visited at regular intervals during the observation period with extra focus on their pain management.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Apr 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: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    39
    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)
    25
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were enrolled from 27/Apr/2015 - 14/Dec/2015.

    Pre-assignment
    Screening details
    62 patients were screened. Reasons for primary exclusion: Operation type not included (n = 5) Logistical reasons ( n = 6) Operation cancelled/rescheduled (n = 4) Daily intake of strong opioids (n = 2) Allergy to opioids (n = 1) Communication problems (n = 1) BMI > 35 (n = 2) Neuropathy (n = 1)

    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, Assessor
    Blinding implementation details
    The hospital pharmacy performed the randomization in blocks of 10 and a 1:1 ratio, and prepared 40 consecutively numbered black nontransparent plastic bags containing 1 mL of saline or 1 mL of dexamethasone according to the randomization list. Isotonic saline and dexamethasone are both transparent liquids, all containers and bags were identical. One patient was excluded due to incorrect inclusion (communication problems) this patient is not included in any data analysis.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention
    Arm description
    Saphenous block with 10 mL Marcain-adrenalin + 1 ml (4 mg) Dexamethasone.
    Arm type
    Experimental

    Investigational medicinal product name
    Dexamethason
    Investigational medicinal product code
    Other name
    Dexagalen
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    4 mg

    Investigational medicinal product name
    Marcain-adrenalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL Marcain-adrenalin containing: BUPIVACAINE HYDROCHLORIDE 5 mg/ml milligram EPINEPHRINE 5 μg/ml

    Arm title
    Control group
    Arm description
    Saphenous block with 10 mL Marcain-adrenalin + 1 mL saline
    Arm type
    Active comparator

    Investigational medicinal product name
    Marcain-adrenalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL Marcain-adrenalin containing: BUPIVACAINE HYDROCHLORIDE 5 mg/ml EOINEOHRINE 5 μg/ml

    Number of subjects in period 1
    Intervention Control group
    Started
    19
    20
    Completed
    19
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 ml (4 mg) Dexamethasone.

    Reporting group title
    Control group
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 mL saline

    Reporting group values
    Intervention Control group Total
    Number of subjects
    19 20 39
    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)
    57.2 ± 12.6 59.8 ± 13.5 -
    Gender categorical
    Units: Subjects
        Female
    9 9 18
        Male
    10 11 21
    ASA physical status
    ASA = American Society of Anesthesiologists
    Units: Subjects
        ASA I
    9 7 16
        ASA II
    10 13 23
    Surgical procedures
    Units: Subjects
        Total ankle replacement
    10 11 21
        Ankle arthrodesis
    2 3 5
        Subtalar arthrodesis
    5 2 7
        Triple arthrodesis
    2 4 6
    BMI
    Body mass index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    28.6 ± 4.07 26.1 ± 4.13 -
    Height
    Units: meter
        arithmetic mean (standard deviation)
    1.76 ± 0.11 1.73 ± 0.1 -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    88.2 ± 13.3 78.1 ± 14 -
    Preoperative pain at rest, NRS
    NRS = numerical rating scale
    Units: Not applicable
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0) 0 (0 to 0.5) -

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 ml (4 mg) Dexamethasone.

    Reporting group title
    Control group
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 mL saline

    Primary: Time until first opioid request

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    End point title
    Time until first opioid request
    End point description
    End point type
    Primary
    End point timeframe
    0-48 hrs Time zero = end of saphenous block performance
    End point values
    Intervention Control group
    Number of subjects analysed
    19
    20
    Units: hour
        arithmetic mean (standard deviation)
    29.4 ± 8.4
    23.2 ± 10.3
    Statistical analysis title
    Time until first opioid request
    Comparison groups
    Intervention v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.048
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    12.3

    Secondary: Time until first pain

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    End point title
    Time until first pain
    End point description
    End point type
    Secondary
    End point timeframe
    0-48 hrs Time zero = End of saphenous block performance
    End point values
    Intervention Control group
    Number of subjects analysed
    19
    20
    Units: hour
        arithmetic mean (standard deviation)
    28.3 ± 7.9
    21.5 ± 10.2
    Statistical analysis title
    Time until first pain
    Statistical analysis description
    T-test Normally distributed data
    Comparison groups
    Intervention v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.026
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    6.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    12.7

    Secondary: Opioid consumption 0-24 hrs

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    End point title
    Opioid consumption 0-24 hrs
    End point description
    The opioid consumption was not normally distributed
    End point type
    Secondary
    End point timeframe
    0-24 hours
    End point values
    Intervention Control group
    Number of subjects analysed
    19
    20
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    1.5 (0 to 14.2)
    Statistical analysis title
    Opioid consumption 0-24 hrs
    Comparison groups
    Intervention v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.046
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Opioid consumption was not normally distributed.

    Secondary: Opioid consumption 24-48 hrs

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    End point title
    Opioid consumption 24-48 hrs
    End point description
    The opioid consumption was not normally distributed
    End point type
    Secondary
    End point timeframe
    24-48 hrs
    End point values
    Intervention Control group
    Number of subjects analysed
    19
    20
    Units: hour
        median (inter-quartile range (Q1-Q3))
    15 (10 to 21)
    15 (5 to 32.5)
    Statistical analysis title
    Opioid consumption 24-48 hrs
    Comparison groups
    Intervention v Control group
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.989
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from inclusion of the first patient 27/Apr/2015 and until the last patient completed the study observation period 16/Dec/2015.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 ml (4 mg) Dexamethasone.

    Reporting group title
    Control group
    Reporting group description
    Saphenous block with 10 mL Marcain-adrenalin + 1 mL saline

    Serious adverse events
    Intervention Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (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
    Intervention Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    8 / 20 (40.00%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    8
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    8
    Nausea
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 20 (25.00%)
         occurrences all number
    5
    8
    Vomiting
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2015
    Changes: Sensory testing at the 42 hour test time is deleted Pain score at 42 the hour test time is deleted Sensory testing and pain score at 42 hours are deleted because this time point consistently is in the middle of the night, and it is difficult to wake up the patients and get valid test results. Furthermore, as most of the patients will be sleeping we find it more ethical to let the patients sleep through the night. Ankle arthrodesis performed as an arthroscopy is removed as an exclusion criteria.

    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.
    Five patients did not require opioids at all. These patients contribute to the primary outcome with the time until a shift in sensory thermanalgesia in the infrapatellar area. This was chosen as the best proxy marker for the end of block duration.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28033159
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