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    Clinical Trial Results:
    Suprascapular nerve block as postoperative analgesia after artroscopic shoulder surgery - a randomized, blinded, placebo controlled trial.

    Summary
    EudraCT number
    		 2015-002391-24
    Trial protocol
    		 DK  
    Global end of trial date
    27 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SSNBCSH01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark, 3400
    Public contact
    Kai Henrik Wiborg Lange, Nordsjaellands Hospital, kai.henrik.wiborg.lange@regionh.dk
    Scientific contact
    Department of Anaesthesiology, Nordsjaellands Hospital, kai.henrik.wiborg.lange@regionh.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 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to examine the reduction in postoperative pain after arthroscopic shoulder surgery in patients treated with a suprascapular nerve block.
    Protection of trial subjects
    Standard postoperative care at the Postoperative Care Unit. Treatment of pain: Active Group: Nerve block and PCA-pump with morphine Placebo Group: PCA-pump with morphine PCA = Patient-controlled analgesia.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    34
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 40

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active group
    Arm description
    		 Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Administered perineurally in relation to the suprascapular nerve as a single shot bolus of 5 ml Ropivacaine 7.5 mg*ml-1

    Arm title
    		 Placebo group
    Arm description
    		 Suprascapular nerve block with placebo (Saline 9 mg*ml-1)
    Arm type
    		 Placebo

    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
    Administered perineurally in relation to the suprascapular nerve as a single shot bolus of 5 ml Saline 9 mg*ml-1

    Number of subjects in period 1
    		Active group Placebo group
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1)

    Reporting group title
    Placebo group
    Reporting group description
    		 Suprascapular nerve block with placebo (Saline 9 mg*ml-1)

    Reporting group values
    		 Active group Placebo group Total
    Number of subjects
    		 20 20 40
    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)
    		 51.6 ( 10.3 ) 54.3 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 9 22
        Male
    		 7 11 18
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.1 ( 8.3 ) 174.5 ( 11.2 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 84.7 ( 13.3 ) 88.6 ( 19.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 Suprascapular nerve block with active drug (Ropivacaine 7.5 mg*ml-1)

    Reporting group title
    Placebo group
    Reporting group description
    		 Suprascapular nerve block with placebo (Saline 9 mg*ml-1)

    Primary: VAS reduction at T30

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    End point title
    		 VAS reduction at T30
    End point description
    Change in pain score (VAS 0-100mm) from baseline to T30 (30 minutes after application of nerve block)
    End point type
    Primary
    End point timeframe
    From Baseline to T30
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: VAS
        arithmetic mean (standard deviation)
    -50.2 ( 17.9 )
    -26.8 ( 9.9 )
    Statistical analysis title
    		 VAS score reduction from baseline to T30
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: VAS AUC T30-T360 during maximum abduction

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    End point title
    		 VAS AUC T30-T360 during maximum abduction
    End point description
    VAS score at maximum active abduction of the shoulder ½-6 hours after injection measured as area under the curve (T30-T360; AUC)
    End point type
    Secondary
    End point timeframe
    From T30-T360
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: VAS
        arithmetic mean (standard deviation)
    134.0 ( 133.3 )
    229.1 ( 93.4 )
    Statistical analysis title
    		 AUC T30-T360 abduction
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: AUC T30-T360 at rest

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    End point title
    		 AUC T30-T360 at rest
    End point description
    VAS score at maximum active abduction of the shoulder ½-6 hours after injection measured as area under the curve (T30-T360; AUC)
    End point type
    Secondary
    End point timeframe
    T30-T360
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: VAS
        arithmetic mean (standard deviation)
    59.5 ( 80.2 )
    134.6 ( 92.0 )
    Statistical analysis title
    		 AUC T30-T360 rest
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Total morphine usage T0-T360

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    End point title
    		 Total morphine usage T0-T360
    End point description
    Total use of morphine from 0-6 hours after injection (T0-T360)
    End point type
    Secondary
    End point timeframe
    T0-T360
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: mg
        arithmetic mean (standard deviation)
    6.5 ( 8.4 )
    18.5 ( 15.7 )
    Statistical analysis title
    		 Morphine T0-T360
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in infraspinatus sEMG from baseline to T30

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    End point title
    		 Change in infraspinatus sEMG from baseline to T30
    End point description
    Change in activity of the infraspinatus muscle during maximum voluntary isometric contraction from baseline to T30 measured with surface EMG (sEMG)
    End point type
    Secondary
    End point timeframe
    From baseline to 30 minutes after injection (T30)
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: mV
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [1] - sEMG signals too poor to analyze
    [2] - sEMG signals too poor to analyze
    No statistical analyses for this end point

    Secondary: Change in external rotation shoulder strength from baseline to T30

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    End point title
    		 Change in external rotation shoulder strength from baseline to T30
    End point description
    Percentage change in maximum voluntary isometric contraction during external rotation of the shoulder from baseline to 30 minutes after injection (T30) measured with a handheld dynamometer.
    End point type
    Secondary
    End point timeframe
    From baseline measurements to 30 minuters after injection (T30)
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: mV
        arithmetic mean (standard deviation)
    -68.9 ( 26.9 )
    9.1 ( 23.0 )
    Statistical analysis title
    		 Change in external rotation strength T0-T30
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change in abduction shoulder strength from baseline to T30

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    End point title
    		 Change in abduction shoulder strength from baseline to T30
    End point description
    Percentage change in maximum voluntary isometric contraction during abduction of the shoulder from baseline to 30 minutes after injection (T30) measured with a handheld dynamometer.
    End point type
    Secondary
    End point timeframe
    From baseline to T30
    End point values
    		 Active group Placebo group
    Number of subjects analysed
    20
    20
    Units: mV
        arithmetic mean (standard deviation)
    -18.9 ( 44.9 )
    27.9 ( 37.4 )
    Statistical analysis title
    		 Change in abduction strength T0-T30
    Comparison groups
    Active group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24th november 2015 - 27th august 2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    DK 2015
    Reporting groups
    Reporting group title
    Ropivacaine 7.5 mg*ml-1
    Reporting group description
    		 -

    Reporting group title
    Saline 9 mg*ml-1
    Reporting group description
    		 -

    Serious adverse events
    		 Ropivacaine 7.5 mg*ml-1 Saline 9 mg*ml-1
    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
    		 Ropivacaine 7.5 mg*ml-1 Saline 9 mg*ml-1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (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: No non-serious adverse events recorded during the study period.

    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.
    Unable to analyze surface electromyography (sEMG) data due to very poor sEMG signals.
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