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:
    Comparison of the analgesic effect of an adductor canal block using a new suture-method catheter vs a standard perineural catheter vs a single bolus: A randomized, blinded, controlled study

    Summary
    EudraCT number
    		 2016-005069-30
    Trial protocol
    		 DK  
    Global end of trial date
    20 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2019
    First version publication date
    14 Nov 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UG1_2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03142789
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gentofte Hospital
    Sponsor organisation address
    Hospitalsvej 1, Copenhagen, Denmark,
    Public contact
    Department of anesthesia, Gentofte Hospital, +45 38673867, jens.ulrik.grevstad@regionh.dk
    Scientific contact
    Department of anesthesia, Gentofte Hospital, +45 38673867, jens.ulrik.grevstad@regionh.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 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypoth-esis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard cath-eter.
    Protection of trial subjects
    All patients had a PCA with opiods
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2017
    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
    Denmark: 153
    Worldwide total number of subjects
    153
    EEA total number of subjects
    153
    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)
    34
    From 65 to 84 years
    113
    85 years and over
    6

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited at Gentofte Hospital, Denmark, from May 2017 to May 2018

    Pre-assignment
    Screening details
    		 402 patients were assessed for eligibility, and 249 excluded

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All patients received the allocated intervention in the PACU immediately after surgery, before spinal anaesthesia had worn off. Opaque sterile drapings covered the view of patients during the procedure. After block procedure, the mid-thigh was covered with opaque dressings and the pump was set to a lock-level that avoided visible pump settings. Thus, all investigators, clinical staff, and patients were blinded to group allocation except for the investigator who performed the intervention.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Certa catheter
    Arm description
    		 Patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 20 ml of 0.2% ropivacaine every 8 hours in the suture-method catheter until 12:00 on postoperative day (POD) 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20ml of 0,2% + bolus 20 ml of 0,2% every 8 hours until 12:00 on POD2

    Arm title
    		 Standard catheter
    Arm description
    		 patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 20 ml of 0.2% ropivacaine every 8 hours in the standard catheter until 12:00 on postoperative day (POD) 2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20ml of 0,2% + bolus 20 ml of 0,2% every 8 hours until 12:00 on POD2

    Arm title
    		 Single bolus
    Arm description
    		 patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 0.1 ml of 0.2% ropivacaine every 8 hours in the sham catheter until 12:00 on postoperative day (POD) 2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20ml of 0,2% + sham bolus 0.1 ml of 0,2% every 8 hours until 12:00 on POD2

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: We have described who is blinded and believe the terms "single" and "double" blinded are obsolete
    Number of subjects in period 1
    		Certa catheter Standard catheter Single bolus
    Started
    51
    51
    51
    Completed
    51
    51
    51

    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
    		 153 153
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 113 113
        85 years and over
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 70 (49 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 98 98
        Male
    		 55 55

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Certa catheter
    Reporting group description
    		 Patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 20 ml of 0.2% ropivacaine every 8 hours in the suture-method catheter until 12:00 on postoperative day (POD) 2

    Reporting group title
    Standard catheter
    Reporting group description
    		 patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 20 ml of 0.2% ropivacaine every 8 hours in the standard catheter until 12:00 on postoperative day (POD) 2

    Reporting group title
    Single bolus
    Reporting group description
    		 patients received an ACB after surgery with an initial bolus of 20 ml 0.75% ropivacaine, followed by 0.1 ml of 0.2% ropivacaine every 8 hours in the sham catheter until 12:00 on postoperative day (POD) 2

    Primary: Total opioid consumption

    		 Close Top of page
    End point title
    		 Total opioid consumption
    End point description
    Total opiod consumption in intravenous morphine equivalents in mg
    End point type
    Primary
    End point timeframe
    From arrival at postoperative care unit until 12:00 on post operative day 2
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: mg
        median (full range (min-max))
    24 (0 to 148)
    38 (0 to 123)
    37 (0 to 158)
    Statistical analysis title
    		 overall
    Statistical analysis description
    Statistical analysis was performed using SPSS 22;. None of the variables, except 6-minute walk tests, was normally distributed, based on skewness, kurtosis, visual inspection of their histograms, Q-Q plots, box plots and Shapiro-Wilk tests. Consequently, all variables were analysed using nonparametric tests.
    Comparison groups
    Certa catheter v Standard catheter v Single bolus
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Parameter type
    		 Median difference (net)
    Confidence interval

    Secondary: Quadriceps strength % of baseline on POD1

    		 Close Top of page
    End point title
    		 Quadriceps strength % of baseline on POD1
    End point description
    Muscle strength was assessed as maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle using a handheld dynamometer (Lafayette Instrument, Lafayette, IN) before surgery and 12:00 on POD 1
    End point type
    Secondary
    End point timeframe
    12:00 on postoperative day 1
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: Percent
        median (inter-quartile range (Q1-Q3))
    35 (27 to 50)
    46 (25 to 62)
    37 (21 to 69)
    No statistical analyses for this end point

    Secondary: Quadriceps strength % of baseline on POD2

    		 Close Top of page
    End point title
    		 Quadriceps strength % of baseline on POD2
    End point description
    Muscle strength was assessed as maximum voluntary isometric contraction (MVIC) of the quadriceps femoris muscle using a handheld dynamometer (Lafayette Instrument, Lafayette, IN) before surgery and 12:00 on POD 2
    End point type
    Secondary
    End point timeframe
    12:00 on POD2
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: Percent
        median (inter-quartile range (Q1-Q3))
    31 (21 to 46)
    27 (22 to 59)
    18 (0 to 32)
    No statistical analyses for this end point

    Secondary: 6 minute walk test - POD1

    		 Close Top of page
    End point title
    		 6 minute walk test - POD1
    End point description
    End point type
    Secondary
    End point timeframe
    12:00 POD 1
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: meter
        median (inter-quartile range (Q1-Q3))
    200 (85 to 264)
    184 (113 to 260)
    160 (76 to 240)
    No statistical analyses for this end point

    Secondary: 6 minute walk test - POD2

    		 Close Top of page
    End point title
    		 6 minute walk test - POD2
    End point description
    End point type
    Secondary
    End point timeframe
    POD2
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: meter
        median (inter-quartile range (Q1-Q3))
    215 (104 to 265)
    200 (133 to 266)
    131 (46 to 207)
    No statistical analyses for this end point

    Secondary: TUG test POD1

    		 Close Top of page
    End point title
    		 TUG test POD1
    End point description
    Timed Up and Go test
    End point type
    Secondary
    End point timeframe
    12:00 POD1
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: second
        median (inter-quartile range (Q1-Q3))
    24 (19 to 34)
    29 (20 to 41)
    27 (19 to 46)
    No statistical analyses for this end point

    Secondary: TUG POD2

    		 Close Top of page
    End point title
    		 TUG POD2
    End point description
    Timed Up and Go test
    End point type
    Secondary
    End point timeframe
    12:00 POD2
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: second
        median (inter-quartile range (Q1-Q3))
    26 (20 to 36)
    27 (20 to 37)
    26 (24 to 64)
    No statistical analyses for this end point

    Secondary: Worst pain during TUG on POD1

    		 Close Top of page
    End point title
    		 Worst pain during TUG on POD1
    End point description
    End point type
    Secondary
    End point timeframe
    12:00 POD1
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: mm on VAS
        median (inter-quartile range (Q1-Q3))
    26 (11 to 51)
    29 (15 to 49)
    36 (18 to 62)
    No statistical analyses for this end point

    Secondary: Worst pain during TUG on POD2

    		 Close Top of page
    End point title
    		 Worst pain during TUG on POD2
    End point description
    End point type
    Secondary
    End point timeframe
    12:00 POD2
    End point values
    		 Certa catheter Standard catheter Single bolus
    Number of subjects analysed
    51
    49
    49
    Units: mm on a VAS
        median (inter-quartile range (Q1-Q3))
    21 (13 to 45)
    21 (7 to 35)
    46 (24 to 87)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From intervention until 12:00 on postoperative day 2
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Serious adverse events
    		 overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 153 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 153 (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: None were 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
    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-Fri May 03 08:01:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA