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    Clinical Trial Results:
    Comparison of 2-chloroprocaïne, bupivacaïne and lidocaïne for spinal anesthesia in knee artroscopy in an outpatient setting: a double blind randomised trial

    Summary
    EudraCT number
    		 2011-003675-11
    Trial protocol
    		 BE  
    Global end of trial date
    30 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AT06/2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    Herestraat 9, Leuven, Belgium,
    Public contact
    Research Anesthesiology, University Hospitals Leuven, 32 16344270, christel.huygens@uzleuven.be
    Scientific contact
    Research Anesthesiology, University Hospitals Leuven, 32 16344270, christel.huygens@uzleuven.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
    08 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We want to investigate the optimal anesthesia for knee arthroscopy in a day-case setting
    Protection of trial subjects
    All patients received standard preemptive pain medication with ketorolac and Paracetamol. In case of insufficient spinal anesthesia, a general anesthesia was performed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Sep 2011
    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
    Belgium: 99
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    90
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In this prospective, double-blind, randomised controlled clinical trial, 99 patients scheduled for diagnostic knee arthroscopy in an ambulatory setting were included.

    Pre-assignment
    Screening details
    		 We included patients aged 18 years and older who were scheduled for elective knee arthroscopy under spinal anesthesia and having an ASA (American Society of Anesthesiologists’) physical status I-III. Exclusion criteria were patients using anti-depressant drugs and/ or anti-psychotic medication, allergies to local anesthetics and known prostate hype

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 chloroprocaine group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    2-Chloroprocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratracheal use
    Dosage and administration details
    40 mg of plain preservative free 2-chloroprocaine 1% was injected intrathecally

    Arm title
    		 Lidocaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    40 mg of plain lidocaine 1% was injected intrathecally

    Arm title
    		 Bupivacaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    7.5 mg of plain bupivacaine 0.5% was injected intrathecally

    Number of subjects in period 1
    		chloroprocaine group Lidocaine Bupivacaine
    Started
    32
    32
    35
    Completed
    32
    32
    35

    Baseline characteristics

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

    Reporting group title
    Lidocaine
    Reporting group description
    		 -

    Reporting group title
    Bupivacaine
    Reporting group description
    		 -

    Reporting group values
    		 chloroprocaine group Lidocaine Bupivacaine Total
    Number of subjects
    		 32 32 35 99
    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
        median (full range (min-max))
    		 47.5 (21 to 76) 48 (19 to 72) 49 (20 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 11 10 19 40
        Male
    		 21 22 16 59

    End points

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

    Reporting group title
    Lidocaine
    Reporting group description
    		 -

    Reporting group title
    Bupivacaine
    Reporting group description
    		 -

    Primary: Time until complete recovery of the sensory block

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    End point title
    		 Time until complete recovery of the sensory block
    End point description
    End point type
    Primary
    End point timeframe
    Time until recovery of sensation to S5
    End point values
    		 chloroprocaine group Lidocaine Bupivacaine
    Number of subjects analysed
    30
    28
    34
    Units: hours
        median (inter-quartile range (Q1-Q3))
    2.6 (2.2 to 2.9)
    3.1 (2.7 to 3.6)
    6.1 (5.5 to 8)
    Statistical analysis title
    		 Recovery of motor block
    Comparison groups
    chloroprocaine group v Lidocaine v Bupivacaine
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01667
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Complete recovery of motor block

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    End point title
    		 Complete recovery of motor block
    End point description
    End point type
    Secondary
    End point timeframe
    Time until a Bromage score of 0 was reached
    End point values
    		 chloroprocaine group Lidocaine Bupivacaine
    Number of subjects analysed
    30
    28
    34
    Units: hours
        median (inter-quartile range (Q1-Q3))
    1.48 (1.32 to 1.8)
    1.83 (1.56 to 2.17)
    3.25 (2 to 4.17)
    Statistical analysis title
    		 Recovery of sensory block
    Comparison groups
    chloroprocaine group v Lidocaine v Bupivacaine
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01667
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Recovery of motor block
    Comparison groups
    chloroprocaine group v Lidocaine v Bupivacaine
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01667
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All patients were observed for adverse events until 24 hours postoperatively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Patients were monitored for transient neurological symptoms, but no patients complained postoperatively.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27281722
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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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