Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Evaluation comparative, en double aveugle, de l'efficacité d'infiltrations locales per et post opératoires de ropivacaïne dans la prise en charge de la douleur après chirurgie hépatique chez l'adulte

    Summary
    EudraCT number
    		 2007-007968-19
    Trial protocol
    		 FR  
    Global end of trial date
    17 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2020
    First version publication date
    26 Feb 2020
    Other versions
    Summary report(s)
    		 DPO

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ET2007-073
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 rue Laennec , LYON Cedex 08, France, 69373
    Public contact
    Dr PERES BACHELOT, Centre Léon Bérard, +33 4 78 78 28 28, DRCIreglementaire@lyon.unicancer.fr
    Scientific contact
    Dr PERES BACHELOT, Centre Léon Bérard, +33 4 78 78 28 28, DRCIreglementaire@lyon.unicancer.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 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluer l'efficacité d'infiltrations locales per et post opératoires (sur le site opératoire) de ropivacaïne versus sérum physiologique, sur la consommation de morphine par le patient au cours des 96 heures postopératoires
    Protection of trial subjects
    Within the framework of this study, the patients included will be followed according to the recommendations for the management of patients operated on for hepatic metastases : medical follow-up with biological assays, tumor markers. The patient's postoperative pain will be assessed using a simple verbal scale, and titrated with morphine hydrochloride. A morphine PCA will be put in place at the end of the titration. No visit or any examination specific to this study is scheduled in addition to the usual follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2009
    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: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    85
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participant will be included by the anesthesiologist or the surgeon who, after verifying their eligibility, will have informed them about the study. After a sufficient reflection period, the participant will be invited to give his consent in writing. This form will also be dated and sign by the investigator.

    Pre-assignment
    Screening details
    		 No screening

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaïne
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    - 40 mL of Ropivacaïne 3,75 mg/ml in infiltration of the entire operating site at the end of the intervention. - 768 mL of Ropivacaïne 2 mg/ml in infiltration continues at a rate of 8 mL/h for 96 hours.

    Arm title
    		 Control Arm
    Arm description
    		 -
    Arm type
    		 Physiological serum

    Investigational medicinal product name
    Physiological serum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    - 40 mL of Physiological serum of the entire operating site at the end of the intervention. - Continuous pre-peritoneal infiltration of physiological serum at a flow rate of 8 mL / h, closing of the peritoneum and for 96 h, via one or more multi-perforated catheters and DM COOPDECH Ballonjector®) or an electric syringe .

    Number of subjects in period 1
    		Experimental Arm Control Arm
    Started
    42
    43
    Completed
    42
    43

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 -

    Reporting group title
    Control Arm
    Reporting group description
    		 -

    Reporting group values
    		 Experimental Arm Control Arm Total
    Number of subjects
    		 42 43 85
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 42 43 85
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 21 32
        Male
    		 31 22 53
    Subject analysis sets

    Subject analysis set title
    Experimental arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is made up of the 85 patients included in the study, including 42 in the Experimental arm (Ropivacaine) and 43 in the Control arm (physiological serum).

    Subject analysis set title
    Control arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is made up of the 85 patients included in the study, including 42 in the Experimental arm (Ropivacaine) and 43 in the Control arm (physiological serum).

    Subject analysis sets values
    		 Experimental arm Control arm
    Number of subjects
    42
    43
    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)
    42
    43
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    11
    21
        Male
    31
    22

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 -

    Reporting group title
    Control Arm
    Reporting group description
    		 -

    Subject analysis set title
    Experimental arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is made up of the 85 patients included in the study, including 42 in the Experimental arm (Ropivacaine) and 43 in the Control arm (physiological serum).

    Subject analysis set title
    Control arm
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is made up of the 85 patients included in the study, including 42 in the Experimental arm (Ropivacaine) and 43 in the Control arm (physiological serum).

    Primary: Endpoint analysis

    		 Close Top of page
    End point title
    		 Endpoint analysis
    End point description
    End point type
    Primary
    End point timeframe
    The patient population not assessable for the primary endpoint was made up of patients for whom the total dose of morphine could not be calculated due to at least one missing data (at least one dose of morphine not given). 8 patients were not assessable.
    End point values
    		 Experimental Arm Control Arm
    Number of subjects analysed
    42
    43
    Units: 96h/kg
        median (full range (min-max))
    1 (0.1 to 4.0)
    1.5 (0.6 to 3.8)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Experimental Arm v Control Arm
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.026
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    The Investigator collects (spontaneous patient report or questioning) and immediately notifies the sponsor of all SAEs, in a written report, whether or not they are deemed to be attributable to research and which occur during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    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: Ropivacaïne arm Control arm Patient with at least 1 AE 25 23 Patient with at least one event treatment related adverse 6 7 Patient with at least one event grade ≥ 3 14 9 Patient with at least one event related adverse grade ≥ 3 3 1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2009
    .modifications of medical devices : - Any multi-perforated catheter with CE marking (instead of systematically using Profolis PaincAth® catheters from Districlass Médical SA) - Continuous infusion pump or an electric syringe with CE marking (instead of systematically using COOPDECH Ballonjector®) .modification of the inclusion balance : the FEVG will now only be performed in the event of a cardiac history and / or abnormal ECG.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 04:15:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA