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    Clinical Trial Results:
    Effect of local anesthetic dose versus volume on block duration of single shot ultrasound-guided axillary brachial plexus block with mepivacaine

    Summary
    EudraCT number
    		 2012-001704-38
    Trial protocol
    		 NL  
    Global end of trial date
    18 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    NL40000.072.012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sint Maartenskliniek
    Sponsor organisation address
    Hengstdal 3, Ubbergen, Netherlands,
    Public contact
    Clinical Trials Information, Sint Maartenskliniek, m.fenten@maartenskliniek.nl
    Scientific contact
    Clinical Trials Information, Sint Maartenskliniek, m.fenten@maartenskliniek.nl
    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
    03 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the present study is to determine the effect of mepivacaine dose and volume on the duration of sensory axillary brachial plexus block (overall and individual nerves).
    Protection of trial subjects
    pain treatment according to standard hospital protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2012
    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
    Netherlands: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    42
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were assessed for eligibility during the preoperative screening visit. Patients were informed about the study verbally and in writing and written informed consent was obtained from all patients.

    Pre-assignment
    Screening details
    		 Eligible patients were adults aged 18 or over with ASA physical health classification I–III, scheduled for single-injection ABPB for hand, wrist or forearm surgery. Exclusion criteria were infection at the injection site, coagulopathy, known hypersensitivity to amide-type local anesthetics, and kknown history of peripheral neuropathy.

    Period 1
    Period 1 title
    overall study (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 anesthetic nurse that prepared the study medication was allowed to disclose allocation to the anesthesiologist that performed the block procedure. Both patients and researcher were blinded for the volume and concentration of anesthetic solution used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A: 20 mL mepivacaine 1.5 %
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    mepivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The patient was placed in the supine position with the head facing away from the arm to be blocked, the arm abducted and the elbow flexed in 90°. A 100-mm 22-gauge insulated short bevel needle (Stimuplex®; B. Braun, Melsungen, Germany) was inserted laterally in the axilla under ultrasound guidance. The musculocutaneous, median, ulnar and radial nerve were identified using ultrasound and the tip of the needle was brought in proximity of each individual nerve subsequently. The needle was connected to a nerve stimulator (Stimuplex® HNS 11; B. Braun) set to deliver 100 nC (0.1 ms, 1 mA) in order to facilitate identification of the individual nerves. The nerves were identified and blocked separately with one fourth of the study medication per nerve. Per patient one skin puncture was made, the needle was retracted subcutaneously and redirected under ultrasound guidance to approach the nerves individually.

    Arm title
    		 Group B: 30 mL mepivacaine 1.0 %
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    mepivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The patient was placed in the supine position with the head facing away from the arm to be blocked, the arm abducted and the elbow flexed in 90°. A 100-mm 22-gauge insulated short bevel needle (Stimuplex®; B. Braun, Melsungen, Germany) was inserted laterally in the axilla under ultrasound guidance. The musculocutaneous, median, ulnar and radial nerve were identified using ultrasound and the tip of the needle was brought in proximity of each individual nerve subsequently. The needle was connected to a nerve stimulator (Stimuplex® HNS 11; B. Braun) set to deliver 100 nC (0.1 ms, 1 mA) in order to facilitate identification of the individual nerves. The nerves were identified and blocked separately with one fourth of the study medication per nerve. Per patient one skin puncture was made, the needle was retracted subcutaneously and redirected under ultrasound guidance to approach the nerves individually.

    Arm title
    		 Group C: 30 mL mepivacaine 1.5 %
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    mepivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The patient was placed in the supine position with the head facing away from the arm to be blocked, the arm abducted and the elbow flexed in 90°. A 100-mm 22-gauge insulated short bevel needle (Stimuplex®; B. Braun, Melsungen, Germany) was inserted laterally in the axilla under ultrasound guidance. The musculocutaneous, median, ulnar and radial nerve were identified using ultrasound and the tip of the needle was brought in proximity of each individual nerve subsequently. The needle was connected to a nerve stimulator (Stimuplex® HNS 11; B. Braun) set to deliver 100 nC (0.1 ms, 1 mA) in order to facilitate identification of the individual nerves. The nerves were identified and blocked separately with one fourth of the study medication per nerve. Per patient one skin puncture was made, the needle was retracted subcutaneously and redirected under ultrasound guidance to approach the nerves individually.

    Number of subjects in period 1
    		Group A: 20 mL mepivacaine 1.5 % Group B: 30 mL mepivacaine 1.0 % Group C: 30 mL mepivacaine 1.5 %
    Started
    16
    18
    15
    Completed
    15
    15
    15
    Not completed
    1
    3
    0
         Consent withdrawn by subject
    1
    -
    -
         block failure
    -
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 -

    Reporting group values
    		 overall study Total
    Number of subjects
    		 49 49
    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)
    		 42 42
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 15 15

    End points

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    End points reporting groups
    Reporting group title
    Group A: 20 mL mepivacaine 1.5 %
    Reporting group description
    		 -

    Reporting group title
    Group B: 30 mL mepivacaine 1.0 %
    Reporting group description
    		 -

    Reporting group title
    Group C: 30 mL mepivacaine 1.5 %
    Reporting group description
    		 -

    Primary: duration of axillary plexus nerve block

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    End point title
    		 duration of axillary plexus nerve block
    End point description
    End point type
    Primary
    End point timeframe
    total duration
    End point values
    		 Group A: 20 mL mepivacaine 1.5 % Group B: 30 mL mepivacaine 1.0 % Group C: 30 mL mepivacaine 1.5 %
    Number of subjects analysed
    15
    15
    15
    Units: minutes
    arithmetic mean (confidence interval 95%)
        overall sensory
    256 (230 to 282)
    226 (209 to 243)
    270 (248 to 291)
        overall motor
    254 (226 to 282)
    220 (200 to 240)
    264 (244 to 284)
    Statistical analysis title
    		 one-way ANOVA was used and Tukey post-hoc analyses
    Comparison groups
    Group A: 20 mL mepivacaine 1.5 % v Group B: 30 mL mepivacaine 1.0 % v Group C: 30 mL mepivacaine 1.5 %
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    for each subject the study duration is defined from the start of the block placement until the return of full motor and sensory skills of all nerves.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    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: this relatively short duration of the study and the small number of study participants is probably the reason that no SAE's took place

    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.
    Three patients were excluded because of block failure, all in Group B. Our study was not set up nor powered to assess success rate of the different concentrations. From a clinical perspective, 1 % mepivacaine may not be a suitable choice for ABPB

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26423050
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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