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    Clinical Trial Results:
    Chloroprocaine vs prilocaine for spinal anaesthesia in day-case surgery: a double-blind randomized trial

    Summary
    EudraCT number
    		 2015-001944-13
    Trial protocol
    		 NL  
    Global end of trial date
    22 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jan 2022
    First version publication date
    28 Jan 2022
    Other versions
    Summary report(s)
    		 Abstract & results

    Trial information

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    Trial identification
    Sponsor protocol code
    ZAA15CPP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zaans Medisch Centrum
    Sponsor organisation address
    Koningin Julianaplein 58, Zaandam, Netherlands, 1502 DV
    Public contact
    Clinical trials information, Zaans Medisch Centrum, wesselink.e@zaansmc.nl
    Scientific contact
    Clinical trials information, Zaans Medisch Centrum, wesselink.e@zaansmc.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
    05 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate effectiveness of spinal chloroprocaine, and prilocaine in day case surgery. The null hypothesis is that there is no significant intergroup difference in time to complete recovery from motor blockade.
    Protection of trial subjects
    METC approval
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Netherlands: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    132
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 150 patients were randomly allocated to receive intrathecally either 40 mg of 2-chloroprocaine or 40 mg of prilocaine.

    Pre-assignment
    Screening details
    		 Patients scheduled for knee arthroscopy with spinal anesthesia were eligible for participation in the study if they were 18 years or older and had an American Society of Anesthesiologists’ physical status I–II.

    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, Carer, Assessor, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prilocaine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prilocaine 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for parenteral use
    Routes of administration
    Intrathecal use
    Dosage and administration details
    40 mc intrathecal

    Arm title
    		 chloroprocaine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    chloroprocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratracheal use
    Dosage and administration details
    chloroprocaine 40 mg intrathecal

    Number of subjects in period 1
    		Prilocaine chloroprocaine
    Started
    75
    75
    Completed
    75
    75

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prilocaine
    Reporting group description
    		 -

    Reporting group title
    chloroprocaine
    Reporting group description
    		 -

    Reporting group values
    		 Prilocaine chloroprocaine Total
    Number of subjects
    		 75 75 150
    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)
    		 49.8 ± 11.2 54.0 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    		 31 34 65
        Male
    		 44 41 85
    Subject analysis sets

    Subject analysis set title
    Prilocaine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Prilocaine

    Subject analysis set title
    Chloroprocaine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Chloroprocaine

    Subject analysis sets values
    		 Prilocaine Chloroprocaine
    Number of subjects
    75
    75
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.9 ± 11.2
    54.0 ± 12.5
    Gender categorical
    Units: Subjects
        Female
    31
    34
        Male
    44
    41

    End points

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    End points reporting groups
    Reporting group title
    Prilocaine
    Reporting group description
    		 -

    Reporting group title
    chloroprocaine
    Reporting group description
    		 -

    Subject analysis set title
    Prilocaine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Prilocaine

    Subject analysis set title
    Chloroprocaine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Chloroprocaine

    Primary: Time to full motor block recovery

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    End point title
    		 Time to full motor block recovery
    End point description
    End point type
    Primary
    End point timeframe
    15 minutes
    End point values
    		 Prilocaine chloroprocaine Prilocaine Chloroprocaine
    Number of subjects analysed
    64
    73
    75
    60
    Units: minutes
        number (confidence interval 5%)
    75 (60 to 90)
    60 (60 to 82.5)
    75 (60 to 90)
    60 (60 to 82.5)
    Attachments
    		 Untitled (Filename: Fig 1. Consort 2010 Flow Diagram.jpg)
    Statistical analysis title
    		 Statistics
    Statistical analysis description
    For all variables, double data entry was used for verification and reconciliation in case of transcription errors and discrepancies caused by illegible data. Categorical variables were summarized per group by means of frequencies and percentages and compared between groups using the chi-square test or using Fisher’s exact test in case of an expected cell count below 5. Continuous variables that were normally distributed were summarized by their mean and standard deviation.
    Comparison groups
    Prilocaine v chloroprocaine
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 days postoperative
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 AE_ARTS_E1_C1_1
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Prilocaine
    Reporting group description
    		 -

    Reporting group title
    Chloroprocaine
    Reporting group description
    		 -

    Serious adverse events
    		 Prilocaine Chloroprocaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 75 (1.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Prolonged hospital stay
    Additional description: Prolonged hospital stay due to nausea&vomiting or pain
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.3%
    Non-serious adverse events
    		 Prilocaine Chloroprocaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 75 (2.67%)
    Surgical and medical procedures
    Conversion to General Anesthesia
    Additional description: spinal anesthesia failure
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 75 (2.67%)
         occurrences all number
    6
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2017
    age 18-64 was changed to >18 years, this was more representative for the population BMI<30 was changed to 'no BMO' limitations, this was more resprentative for the population Both inclusion criteria were approved by the METC

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31439640
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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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