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    Clinical Trial Results:
    Magnetic Resonance Imaging of Local Anesthetic Distribution: A Comparison of 5 and 15 milliliters of ropivacaine 0.75% for ultrasound guided interscalene plexus blockade

    Summary
    EudraCT number
    		 2013-004219-36
    Trial protocol
    		 AT  
    Global end of trial date
    01 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2021
    First version publication date
    16 May 2021
    Other versions
    Summary report(s)
    		 Manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    MR-ISB-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02175069
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Paracelsus Mediznische Privatuniversität, Universitätsklinik für Anästhesiologie, perioperative Medizin und Intensiv
    Sponsor organisation address
    Muellner Haupstrasse 48, Salzburg, Austria, 5020
    Public contact
    Department of Anesthesia and Intensive Care, Paracelsus Medical University, Muellner Hauptstrasse 48, Paracelsus Medical University, 43 57255, p.gerner1@salk.at
    Scientific contact
    Department of Anesthesia and Intensive Care, Paracelsus Medical University, Muellner Hauptstrasse 48, Paracelsus Medical University, 43 57255, p.gerner1@salk.at
    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 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to confirm that the frequency of epidural spread correlates with higher volumes of local anesthetic injection (5ml vs 20ml) after interscalene brachial plexus block.
    Protection of trial subjects
    Standard clinical care for routine procedure
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2014
    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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    28
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 30 patients scheduled to undergo shoulder surgery were included. Eligible patients were identified and approached consecutively during their pre-surgical evaluation in the anaesthesia clinic one day prior to surgery, informed about the study, and if they agreed to participate, were asked to provide written consent.

    Pre-assignment
    Screening details
    		 Of the 31 patients deemed eligible for participation, thirty (96.8%) agreed to participate.

    Period 1
    Period 1 title
    Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    On the day of surgery, an unblinded anaesthesia nurse not otherwise involved in the study prepared the study medication according to the randomisation result in the envelope. All blocks were performed in the MRI scanner anteroom, by a blinded single practitioner (GF) with many years of experience in regional anaesthesia.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low Volume Group
    Arm description
    		 Patients received 5 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.0125 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).
    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
    5 ml ropivacaine 0.75%

    Investigational medicinal product name
    Gadopentetat-Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    0.0125mmol

    Arm title
    		 High Volume Group
    Arm description
    		 Patients received 20 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.05 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).
    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
    20 ml ropivacaine 0.75%

    Investigational medicinal product name
    Gadopentetat-Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    0.05mmol

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The block provider (anesthesiologist) was not blinded.
    Number of subjects in period 1
    		Low Volume Group High Volume Group
    Started
    15
    15
    Completed
    15
    15
    Period 2
    Period 2 title
    Analysis
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [2]
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low Volume Group
    Arm description
    		 Patients received 5 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.0125 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadopentetat-Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    0.0125mmol

    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
    5 ml ropivacaine 0.75%

    Arm title
    		 High Volume Group
    Arm description
    		 Patients received 20 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.05 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadopentetat-Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    0.05mmol

    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
    20 ml ropivacaine 0.75%

    Notes
    [2] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The block provider (anesthesiologist) was not blinded.
    Number of subjects in period 2
    		Low Volume Group High Volume Group
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low Volume Group
    Reporting group description
    		 Patients received 5 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.0125 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).

    Reporting group title
    High Volume Group
    Reporting group description
    		 Patients received 20 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.05 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).

    Reporting group values
    		 Low Volume Group High Volume Group Total
    Number of subjects
    		 15 15 30
    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)
    		 50 ± 17 55 ± 14 -
    Gender categorical
    Units: Subjects
        Female
    		 6 9 15
        Male
    		 9 6 15
    procedure type
    Units: Subjects
        Arthroscopic
    		 10 13 23
        Open
    		 5 2 7
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.3 ± 5.4 26.7 ± 4.7 -
    Craniocaudad distance
    Craniocaudal distance
    Units: mm
        arithmetic mean (standard deviation)
    		 115.6 ± 10.1 115.3 ± 10.3 -
    Transaxial distance
    Units: mm
        arithmetic mean (standard deviation)
    		 127.1 ± 18.1 126.2 ± 16.3 -
    Neck coefficient
    Units: none
        arithmetic mean (standard deviation)
    		 0.92 ± 0.12 0.92 ± 0.12 -

    End points

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    End points reporting groups
    Reporting group title
    Low Volume Group
    Reporting group description
    		 Patients received 5 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.0125 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).

    Reporting group title
    High Volume Group
    Reporting group description
    		 Patients received 20 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.05 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).
    Reporting group title
    Low Volume Group
    Reporting group description
    		 Patients received 5 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.0125 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).

    Reporting group title
    High Volume Group
    Reporting group description
    		 Patients received 20 ml of ropivacaine 0.75% (Naropin®; AstraZeneca Austria GmbH, Vienna, Austria) mixed with 0.05 mmol of the contrast dye, gadopentetate-dimeglumine (Magnevist® 0.5 mmol ml-1; Bayer Vital GmbH, Leverkusen, Germany).

    Primary: epidural spread

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    End point title
    		 epidural spread
    End point description
    End point type
    Primary
    End point timeframe
    during MRI
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no epidural spread
    13
    13
        epidural spread
    2
    2
    Statistical analysis title
    		 chisq
    Comparison groups
    High Volume Group v Low Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: spread around intervertebral foramen

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    End point title
    		 spread around intervertebral foramen
    End point description
    End point type
    Secondary
    End point timeframe
    during MRI
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no spread
    15
    11
        spread
    0
    4
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.032
    Method
    		 Chi-squared
    Confidence interval

    Secondary: spread around phrenic nerve

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    End point title
    		 spread around phrenic nerve
    End point description
    End point type
    Secondary
    End point timeframe
    during MRI
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no spread
    13
    1
        spread
    2
    14
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: intramuscular spread

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    End point title
    		 intramuscular spread
    End point description
    End point type
    Secondary
    End point timeframe
    during MRi
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        spread
    6
    15
        no spread
    9
    0
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: time to start of pca

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    End point title
    		 time to start of pca
    End point description
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: minutes
        median (standard deviation)
    498 ± 245
    755 ± 230
    Statistical analysis title
    		 mannw
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.013
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PCA ropivacaine consumption

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    End point title
    		 PCA ropivacaine consumption
    End point description
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: milliliters
        median (standard deviation)
    142 ± 42
    118 ± 117
    Statistical analysis title
    		 mannw
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.71
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: diclofenac consumption

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    End point title
    		 diclofenac consumption
    End point description
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no diclofenac
    9
    12
        diclofenac
    6
    3
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.23
    Method
    		 Chi-squared
    Confidence interval

    Secondary: paracetamol consumption

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    End point title
    		 paracetamol consumption
    End point description
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no paracetamol
    9
    11
        paracetamol
    6
    4
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.44
    Method
    		 Chi-squared
    Confidence interval

    Secondary: piritramid consumption

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    End point title
    		 piritramid consumption
    End point description
    End point type
    Secondary
    End point timeframe
    during study
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: patients
        no piritramid
    12
    14
        piritramid
    3
    1
    Statistical analysis title
    		 chisq
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.28
    Method
    		 Chi-squared
    Confidence interval

    Secondary: pain at rest

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    End point title
    		 pain at rest
    End point description
    End point type
    Secondary
    End point timeframe
    postop
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: VAS
        arithmetic mean (standard deviation)
    0.47 ± 1.36
    0.43 ± 1.36
    Statistical analysis title
    		 ANOVA
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.98
    Method
    		 ANOVA
    Confidence interval

    Secondary: pain with movement

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    End point title
    		 pain with movement
    End point description
    End point type
    Secondary
    End point timeframe
    postop
    End point values
    		 Low Volume Group High Volume Group
    Number of subjects analysed
    15
    15
    Units: vas
        arithmetic mean (standard deviation)
    1.07 ± 2.09
    0.50 ± 1.87
    Statistical analysis title
    		 anova
    Comparison groups
    Low Volume Group v High Volume Group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.89
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Entire Study Period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: There were no minor adverse events.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/2686513
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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
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