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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    The effect of popliteal plexus block on pain after total knee replacement.

    Summary
    EudraCT number
    		 2017-001644-35
    Trial protocol
    		 DK  
    Global end of trial date
    20 Feb 2018

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CR_TFB_2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03198403
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Nørrebrogade 44, Aarhus, Denmark, 8000
    Public contact
    Centre of Elective Surgery, Silkeborg Regional Hospital, 0045 25883172,
    Scientific contact
    Centre of Elective Surgery, Silkeborg Regional Hospital, 0045 25883172, charlotte.runge@aarhus.rm.dk
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Nørrebrogade 44, Aarhus, Denmark, 8000
    Public contact
    Silkeborg regional hospital, Aarhus university hospital, 0045 25883172, charlotte.runge@aarhus.rm.dk
    Scientific contact
    Silkeborg regional hospital, Anesthesia depart., Aarhus university hospital, 0045 51542997, tfb@dadlnet.dk
    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
    20 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this trial is to evaluate the effect of popliteal plexus block (PPB) on pain after total knee replacement (TKR)
    Protection of trial subjects
    The trial was monitored by the Good Clinical Practice (GCP) Unit at Aalborg and Aarhus University Hospitals. Written informed consent was obtained from all subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    2
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited at Silkeborg Regional Hospital, Denmark, from August to September 2017.

    Pre-assignment
    Screening details
    		 Eligibility criteria for the study included patients older than 18 years and American Society of Anaesthesiologists (ASA) score 1‐3 who were scheduled for cemented, unilateral, primary TKA with spinal anaesthesia. The exclusion criteria were inability to cooperate, non‐Danish speakers, pregnancy, diabetes, reduced sensation on the lower limb, daily

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

    Arms
    Arm title
    		 active popliteal plexus block
    Arm description
    		 patients received an active PPB, if NRS exceed 3
    Arm type
    		 Active comparator

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL of bupivacaine 5 mg/ml

    Number of subjects in period 1
    		active popliteal plexus block
    Started
    10
    Completed
    10

    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
    		 10 10
    Age categorical
    Population are patients from 50 years and over.
    Units: Subjects
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 8 8
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (65 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    statistical analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Statistical analysis was conducted with STATA 14 (Stata Corp, Col- lege Station, TX, USA). Continuous variables with normal distribution were presented as mean (standard deviation and confidence inter- val). Normality of distribution was tested with histograms and QQ- plots. Nonparametric distributions were presented as median (IQR, interquartile range). Paired comparison of non-Gaussian continuous variables (isometric muscle strength) was carried out with the Wil- coxon signed rank test.

    Subject analysis sets values
    		 statistical analysis
    Number of subjects
    10
    Age categorical
    Population are patients from 50 years and over.
    Units: Subjects
        Adults (18-64 years)
    5
        From 65-84 years
    12
    Age continuous
    Units: years
        median (full range (min-max))
    70 (50 to 85)
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    active popliteal plexus block
    Reporting group description
    		 patients received an active PPB, if NRS exceed 3

    Subject analysis set title
    statistical analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Statistical analysis was conducted with STATA 14 (Stata Corp, Col- lege Station, TX, USA). Continuous variables with normal distribution were presented as mean (standard deviation and confidence inter- val). Normality of distribution was tested with histograms and QQ- plots. Nonparametric distributions were presented as median (IQR, interquartile range). Paired comparison of non-Gaussian continuous variables (isometric muscle strength) was carried out with the Wil- coxon signed rank test.

    Primary: pain reduction

    		 Close Top of page
    End point title
    		 pain reduction [1]
    End point description
    If a subject reported a pain score of NRS >3, a PPB was carried out. Prior to the PPB, the location of pain was registered as pain in the anterior, the posterior, the medial, or the lateral aspect of the knee, deep knee pain, pain in the thigh or diffuse pain. The end of injec- tion of the PPB was defined as popliteal plexus block time 0 (PPB t0 ) . The pain score (NRS 0-10) and the cutaneous sensation (0-2) on the lateral side of the operated leg were assessed every 5 minutes after PPB t0 until NRS ≤3 or a maximum of 60 minutes after PPB t0 .
    End point type
    Primary
    End point timeframe
    The primary outcome was the proportion of subjects reporting pain above NRS 3 within the observation period, who had a reduction in pain score to NRS ≤3 within 1 hour after PPB.
    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 study was a feasibility study. Counting the number of patients having significant pain and apply percentage.
    End point values
    		 statistical analysis
    Number of subjects analysed
    17
    Units: subjects
    10
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events were observed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No adverse events were observed in the study

    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
    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-Sat Apr 27 22:52:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA