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    Clinical Trial Results:
    PROTOCOLE D’ANALGESIE POST OPERATOIRE PAR INFILTRATION CONTINUE DE ROPIVACAINE DANS LES ARTHRODESES DU RACHIS LOMBAIRE

    Summary
    EudraCT number
    		 2008-004705-34
    Trial protocol
    		 FR  
    Global end of trial date
    17 Dec 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    		 Final Rapport

    Trial information

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    Trial identification
    Sponsor protocol code
    08-CIR-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    chu de nice
    Sponsor organisation address
    DRCI-Hôpital de Cimiez - 4 avenue reine victoria, Nice, France, 06003
    Public contact
    Direction de la Recherche clinique, DRCI, +33 492034589, caillon.c@chu-nice.fr
    Scientific contact
    Investigateur , Pr Litrico, +33 492036217 , caillon.c@chu-nice.fr
    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
    17 Dec 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.
    Protection of trial subjects
    The patients signed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2008
    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
    France: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After we obtained approval from the ethics committee and informed, written consent from patients, patients older than 18 years old , heavier than 50 kg, without psychological disorders, benefiting from of arthrodesis scheduled by a rachis lumbar posterior way were enrolled. Patients were randomized to one of the two following postoperative analg

    Period 1
    Period 1 title
    Inclusion Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ropivacaine or serum
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for intravesical solution
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    200mg of ropivacaïne 0,5 %

    Number of subjects in period 1
    		Ropivacaine or serum
    Started
    58
    Completed
    58

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inclusion Period
    Reporting group description
    		 -

    Reporting group values
    		 Inclusion Period Total
    Number of subjects
    		 58 58
    Age categorical
    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)
    		 58 58
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 33 33

    End points

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    End points reporting groups
    Reporting group title
    Ropivacaine or serum
    Reporting group description
    		 -

    Primary: Levels of pain

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    End point title
    		 Levels of pain [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statiscal analyses have been specified for this primary end point in the document attached.
    End point values
    		 Ropivacaine or serum
    Number of subjects analysed
    58
    Units: NA
    58
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At 2 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Ropivacaine
    Reporting group description
    		 -

    Serious adverse events
    		 Ropivacaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ropivacaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (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: Any adverse events

    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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