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    Clinical Trial Results:
    Comparative doubleblind study with prilocaine 2 % and 2-chloroprocaine for elective caesarean section.

    Summary
    EudraCT number
    		 2016-000813-63
    Trial protocol
    		 BE  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Sep 2020
    First version publication date
    11 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TACs
    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 2+4763134, veerle.vanmossevelde@uzbrussel.be
    Scientific contact
    Data nurse, Universitair Ziekenhuis Brussel, +32 2+4763134, veerle.vanmossevelde@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
    Interim
    Date of interim/final analysis
    30 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2018
    Global end of trial reached?
    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 caesarean section with and without the use of Sufenta: as well as onset of action and duration of action, the degree of motor block and level of sensory block will be investigated.
    Protection of trial subjects
     Deze klinische studie wordt opgestart na evaluatie door één of meerdere ethische comité(s).  Uw deelname is vrijwillig; er kan op geen enkele manier sprake zijn van dwang. Voor deelname is uw ondertekende toestemming nodig. Ook nadat u hebt getekend, kan u de arts-onderzoeker laten weten dat u uw deelname wilt stopzetten. De beslissing om al dan niet (verder) deel te nemen zal geen enkele negatieve invloed hebben op de kwaliteit van de zorgen noch op de relatie met de behandelende arts(en).  De gegevens die in het kader van uw deelname worden verzameld, zijn vertrouwelijk. Bij de publicatie van de resultaten is uw anonimiteit verzekerd.  Er worden u geen kosten aangerekend voor specifieke behandelingen, bezoeken / consultaties, onderzoeken in het kader van deze studie.  Er is een verzekering afgesloten voor het geval dat u schade zou oplopen in het kader van uw deelname aan deze klinische studie.  Indien u extra informatie wenst, kan u altijd contact opnemen met de arts-onderzoeker of een medewerker van zijn of haar team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2016
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients from UZ Brussels who come in for a caesarean are asked to participate in the study.

    Pre-assignment
    Screening details
    		 Inclusion: female, 18-45 years old, ASA I or II, uncomplicated singleton pregnancy at term or indication for elective caesarean delivery.

    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
    Blinding implementation details
    Group allocation will be performed according to a computerised randomisation list. Supervising anaesthesiologist will perform combined spinal and epidural puncture after receiving a closed envelop with group allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 60 mg prilocaine 2% and 2 mcg sufentanil
    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
    Epidural use
    Dosage and administration details
    60 mg prilocaine

    Investigational medicinal product name
    sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intrathecal use
    Dosage and administration details
    2 mcg sufentanil

    Arm title
    		 Group B
    Arm description
    		 60 mg prilocaine 2% en 3 mcg sufentanil
    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
    Epidural use
    Dosage and administration details
    60 mg prilocaine

    Investigational medicinal product name
    sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intrathecal use
    Dosage and administration details
    3 mcg sufentanil

    Arm title
    		 Group C
    Arm description
    		 60 mg prilocaine + 4 mcg sufentanil
    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
    Epidural use
    Dosage and administration details
    60 mg prilocaine

    Investigational medicinal product name
    sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intrathecal use
    Dosage and administration details
    4 mcg sufentanil

    Arm title
    		 Group D
    Arm description
    		 60 mg prilocaine en 1 mcg sufentanil
    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
    Epidural use
    Dosage and administration details
    60 mg prilocaine

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

    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    20
    20
    20
    20
    Completed
    20
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 60 mg prilocaine 2% and 2 mcg sufentanil

    Reporting group title
    Group B
    Reporting group description
    		 60 mg prilocaine 2% en 3 mcg sufentanil

    Reporting group title
    Group C
    Reporting group description
    		 60 mg prilocaine + 4 mcg sufentanil

    Reporting group title
    Group D
    Reporting group description
    		 60 mg prilocaine en 1 mcg sufentanil

    Reporting group values
    		 Group A Group B Group C Group D Total
    Number of subjects
    		 20 20 20 20 80
    Age categorical
    All females between 18 and 45 years old.
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 20 20 20 20 80
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Female
    Units: Subjects
        Female
    		 20 20 20 20 80
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 60 mg prilocaine 2% and 2 mcg sufentanil

    Reporting group title
    Group B
    Reporting group description
    		 60 mg prilocaine 2% en 3 mcg sufentanil

    Reporting group title
    Group C
    Reporting group description
    		 60 mg prilocaine + 4 mcg sufentanil

    Reporting group title
    Group D
    Reporting group description
    		 60 mg prilocaine en 1 mcg sufentanil

    Primary: Sensory and motor function

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    End point title
    		 Sensory and motor function
    End point description
    Sensory and motor function will be evaluated with an ether skin test and with a standardised motor score respectively.
    End point type
    Primary
    End point timeframe
    5 minutes post injection
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    20
    20
    20
    20
    Units: 0, 1, 2, 3
        number (not applicable)
    20
    20
    20
    20
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Comparison between groups will be performed by one-way ANOVA testing, followed by independent sample t-testing, when appropriate. Discontinuous data will be approached by a Fisher exact test.
    Comparison groups
    Group A v Group B v Group C
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 T-test
    Statistical analysis description
    Comparison between groups will be performed by one-way ANOVA testing, followed by independent sample t-testing, when appropriate. Discontinuous data will be approached by a Fisher exact test.
    Comparison groups
    Group A v Group B v Group C
    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
    		 FISHER
    Statistical analysis description
    Comparison between groups will be performed by one-way ANOVA testing, followed by independent sample t-testing, when appropriate. Discontinuous data will be approached by a Fisher exact test.
    Comparison groups
    Group A v Group B v Group C
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Comparison between groups will be performed by one-way ANOVA testing, followed by independent sample t-testing, when appropriate. Discontinuous data will be approached by a Fisher exact test.
    Comparison groups
    Group A v Group B v Group C
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Sensory and motor function post caesarean

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    End point title
    		 Sensory and motor function post caesarean
    End point description
    Sensory and motor function will be evaluated with an ether skin test and with a standardised motor score.
    End point type
    Primary
    End point timeframe
    1 hour and every 15 minutes after termination of caesarean section.
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    20
    20
    20
    20
    Units: 0, 1, 2, 3
        number (not applicable)
    20
    20
    20
    20
    Statistical analysis title
    		 anova
    Statistical analysis description
    Comparison between groups will be performed by one-way ANOVA testing, followed by independent sample t-testing, when appropriate. Discontinuous data will be approached by a Fisher exact test.
    Comparison groups
    Group A v Group B v Group C v Group D
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 days postoperative
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 80 (1.25%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Bleeding time abnormal
    Additional description: Hysterectomie was performed due to excessive postoperative bleeding.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 80 (2.50%)
    Pregnancy, puerperium and perinatal conditions
    Placenta accreta
    Additional description: Placenta accreta with bleeding
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hypotension
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2020
    We would like to add an open arm label to the previous study, where we use prilocaïne 2% + 1µg sufentanil. The objective of the study was to determine the ideal dose of spinal sufentanil in elective caesarean delivery. Therefore we used 3 different doses of sufentanil. However, we’ve noticed that all patient were comfortable at a doses of 2 µg sufentanil, so we would like to see if it is possible to diminish the intrathecal dose even further, which would have a positive effect also on side effects.

    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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