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    Clinical Trial Results:
    Comparative study with prilocaine 1% and prilocaine 1.5% for ultrasound guided axillary brachial plexus blockade

    Summary
    EudraCT number
    		 2015-002744-14
    Trial protocol
    		 BE  
    Global end of trial date
    13 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2020
    First version publication date
    28 Aug 2020
    Other versions
    Summary report(s)
    		 Results Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    PRILPLEXUS1%-1.5%
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussels
    Sponsor organisation address
    Laarbeeklaan 101, Jette, Belgium, 1090
    Public contact
    Data Nurse, Universitair Ziekenhuis Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.be
    Scientific contact
    Data Nurse, Universitair Ziekenhuis Brussel, +32 24763134, veerle.vanmossevelde@uzbrussel.be
    Sponsor organisation name
    UZ Brussels
    Sponsor organisation address
    Laarbeeklaan 101, Jette, Belgium, 1090
    Public contact
    Evelien Vandeurzen, University Hospital Brussels, 0032 24749237, evelien.vandeurzen@uzbrussel.be
    Scientific contact
    Evelien Vandeurzen, UZ Brussel, 0032 24749237, evelien.vandeurzen@uzbrussel.be
    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
    13 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In this study we will investigate the difference between prilocaine 1% and prilocaine 1.5% in relation to the time of onset of sensory and motor blockade and the quality and the duration of the block. In addition we will investigate if there is an effect of prilocaine in the used doses on the methemoglobinemia.
    Protection of trial subjects
    If a block failed, patients received a rescue block or if necessary general anesthesia. Supplemental anesthesia was sometimes also given if complaints of discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    39
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was conducted at the Universitair Ziekenhuis Brussel (Brussels University Hospital). A total of 60 patients, ASA I-III, scheduled for elective minor hand or for forearm surgery were included. Patients were assessed for eligibility durig the preoperative anesthesia consultation.

    Pre-assignment
    Screening details
    		 Exclusion criteria were: age < 18 years old, contra-indications for loco-regional anesthesia, and peripheral neurological disorders. Diabetic patients were included unless peripheral polyneuropathy was diagnosed or suspected.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Patient did not know which block they were receiving. Only physician knew.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients receive prilocaine 1%
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prilocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    20 ml of prilocaine 1% for group A. Prilocaine 2% was diluted with normal saline to obtain 20 ml of the desired concentration.

    Arm title
    		 Group B
    Arm description
    		 Prilocaine 1.5%
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prilocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    20 ml of prilocaine 1.5% for group B. Prilocaine 2% was diluted with normal saline to obtain 20 ml of the desired concentration.

    Number of subjects in period 1
    		Group A Group B
    Started
    30
    30
    Completed
    26
    29
    Not completed
    4
    1
         Lack of efficacy
    4
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients receive prilocaine 1%

    Reporting group title
    Group B
    Reporting group description
    		 Prilocaine 1.5%

    Primary: Overall duration of sensory and motor block

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    End point title
    		 Overall duration of sensory and motor block
    End point description
    End point type
    Primary
    End point timeframe
    5 Hours after block placement.
    End point values
    		 Group A Group B
    Number of subjects analysed
    26
    29
    Units: minute
        number (not applicable)
    26
    29
    Attachments
    		 Excel file
    Statistical analysis title
    		 M-ANOVA test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Primary: Methemoglobin level

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    End point title
    		 Methemoglobin level
    End point description
    End point type
    Primary
    End point timeframe
    2 hours after block placement.
    End point values
    		 Group A Group B
    Number of subjects analysed
    26
    29
    Units: percent volume/volume
        number (not applicable)
    26
    29
    Attachments
    		 Table 2
    Statistical analysis title
    		 M-ANOVA test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Patient satisfaction

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    End point title
    		 Patient satisfaction
    End point description
    End point type
    Primary
    End point timeframe
    Post-operative asked questionnaire
    End point values
    		 Group A Group B
    Number of subjects analysed
    26
    29
    Units: scale of 1-10
    26
    29
    Attachments
    		 See Column N
    Statistical analysis title
    		 M-ANOVA test
    Comparison groups
    Group A v Group B
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Local anesthetic systemic toxicity

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    End point title
    		 Local anesthetic systemic toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    6 months after surgery
    End point values
    		 Group A Group B
    Number of subjects analysed
    26
    29
    Units: number of patients with complaints
    26
    29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Start of surgery till 6 months post-op.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Total group
    Reporting group description
    		 -

    Serious adverse events
    		 Total group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Total group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 60 (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: There were no adverse events reported.

    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 reported
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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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