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    Clinical Trial Results:
    Randomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.

    Summary
    EudraCT number
    		 2013-002815-88
    Trial protocol
    		 BE  
    Global end of trial date
    26 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2020
    First version publication date
    30 Sep 2020
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    BUPCHLOR1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussel
    Sponsor organisation address
    Laarbeeklaan 101, Jette, Belgium, 1090
    Public contact
    Department of Anesthesiology, UZ Brussel, 24763618 24763618, luc.puis@uzbrussel.be
    Scientific contact
    Department of Anesthesiology, UZ Brussel, 24763618 24763618, luc.puis@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
    26 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this trial is to investigate the efficacy of the IMP during c-section with and without the use of Sufenta: As well as start of action, duration of action, the degree of motor and sensory block as well as the hight of the block itselfs will be investigated.
    Protection of trial subjects
    If patients of a certain group was in distress there was a rescue dose available.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2013
    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: 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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion: in-term (≥ 37 weeks),ASA I,II, planned CS,uncomplicated, singleton pregnancy, age 18-40 years. Exclusion: ASA III,IV, urgent/emergent CS, twin/multiple pregnancy, gestational age<37 weeks, BMI > 35, maternal height < 150 cm, foetus with known or suggested congenital malformations, known allergy for anaesthetics and (pre)eclampsia.

    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
    Anesthesiologist receives an envelop to know which group the patient will be in. Patient is not informed of which medication they will receive.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group C
    Arm description
    		 Patients received 2-chloroprocaine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chloroprocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    40 mg 2-chloroprocaine spinal-epidural

    Arm title
    		 Group C+S
    Arm description
    		 Patients receive 2-chloroprocaine and sufentanil
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chloroprocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    40 mg 2-chloroprocaine spinal-epidural

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    1 mcg sufentanil spinal-epidural

    Arm title
    		 Group B+S
    Arm description
    		 Hyperbaric bupivacaine (9 mg) with sufentanil (1 mcg)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    1 mcg sufentanil spinal-epidural

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    Hyperbaric bupivacaine 9 mg and 1 mcg of sufentanil were spinal-epidural given to patients.

    Number of subjects in period 1
    		Group C Group C+S Group B+S
    Started
    20
    20
    20
    Completed
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 60 60
    Age categorical
    Age 18-40
    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)
    		 60 60
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Female
    Units: Subjects
        Female
    		 60 60
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group C
    Reporting group description
    		 Patients received 2-chloroprocaine.

    Reporting group title
    Group C+S
    Reporting group description
    		 Patients receive 2-chloroprocaine and sufentanil

    Reporting group title
    Group B+S
    Reporting group description
    		 Hyperbaric bupivacaine (9 mg) with sufentanil (1 mcg)

    Primary: Time to motor block

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    End point title
    		 Time to motor block
    End point description
    End point type
    Primary
    End point timeframe
    Time in minutes starting from IMP injection to motor block.
    End point values
    		 Group C Group C+S Group B+S
    Number of subjects analysed
    20
    20
    20
    Units: minutes
        number (not applicable)
    20
    20
    20
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 t-test
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Fischer
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Time to motor block resolution

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    End point title
    		 Time to motor block resolution
    End point description
    How long does it take for the patients to have full motor recovery after the caesarean.
    End point type
    Secondary
    End point timeframe
    Time after surgery in minutes.
    End point values
    		 Group C Group C+S Group B+S
    Number of subjects analysed
    20
    20
    20
    Units: minutes
        number (not applicable)
    20
    20
    20
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - randomly selected values X and Y from two populations, the probability that X is greater than Y is equal to the probability that Y is greater than X.
    Statistical analysis title
    		 T-test between groups
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 Fisher
    Comparison groups
    Group C v Group C+S v Group B+S
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the caesarean and 1 day postop.
    Adverse event reporting additional description
    There were no Adverse Events reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    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: 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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