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   43871   clinical trials with a EudraCT protocol, of which   7290   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:
    Pharmacokinetic Profile of Ropivacaïne after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty

    Summary
    EudraCT number
    		 2014-003010-93
    Trial protocol
    		 NL  
    Global end of trial date
    30 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions
    Summary report(s)
    		 Pharmacokinetics of 400 mg ropivacaine after periarticular local infiltration analgesia for total knee arthroplasty

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    620
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sint Maartenskliniek
    Sponsor organisation address
    Hengstdal 3, Ubbergen, Netherlands,
    Public contact
    afdeling Research, Sint Maartenskliniek, secretariaat.rde@maartenskliniek.nl
    Scientific contact
    afdeling Research, Sint Maartenskliniek, secretariaat.rde@maartenskliniek.nl
    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
    31 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Although considered safe, no pharmacokinetic data of high dose, high volume local infiltration analgesia (LIA) with ropivacaine without the use of a surgical drain or intra-articular catheter have been described. The purpose of this study is to describe the maximum total and unbound ropivacaine concentrations (Cmax, Cu max) and corresponding maximum times (Tmax, Tu max) of a single-shot ropivacaine (200 ml 0.2%) and 0.75 mg epinephrine (1000 lg/ml) when used for LIA in patients for total knee arthroplasty.
    Protection of trial subjects
    all study patients were treated according to standard hospital protocol and blood was drawn from an indwelling IV catheter.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    Netherlands: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    1
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 scheduled for primary total knee replacement 50-80 years ASA score I or II BMI < 40 kg/m2 Hb > 7.5 mmol/L

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 study patients
    Arm description
    		 all study patients are enrolled in the one same study without any distiction between them and no groups made
    Arm type
    		 Experimental

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    400 mg ropivacaine in 200 mL (0.2%) is infiltrated in and around the knee

    Number of subjects in period 1
    		study patients
    Started
    20
    Completed
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 20 20
    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
        arithmetic mean (standard deviation)
    		 58.5 ± 6.7 -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 12 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    study patients
    Reporting group description
    		 all study patients are enrolled in the one same study without any distiction between them and no groups made

    Primary: Cmax

    		 Close Top of page
    End point title
    		 Cmax [1]
    End point description
    End point type
    Primary
    End point timeframe
    baseline, 20, 40, 60, 90, 120, 240, 360, 480, 600, 720 and 1440 minutes after closure of the wound.
    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: data are descriptive, no comparison is made therefore no statistical comparison is available
    End point values
    		 study patients
    Number of subjects analysed
    20
    Units: microgram(s)/millilitre
        median (inter-quartile range (Q1-Q3))
    1.00 (0.66 to 1.34)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    during study enrollment (from start of surgery untill 1440 minutes after wound closure)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 toetsingonline
    Dictionary version
    1
    Reporting groups
    Reporting group title
    study group
    Reporting group description
    		 -

    Serious adverse events
    		 study group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 study group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (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: during this very short study period and very small sample size no non-serious adverse events are recorded

    More information

    		 Close Top of page

    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/28066882
    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-Thu May 02 13:20:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA