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:
    Does perineural clonidin prolong the duration of an adductor canal block when controlling for a systemic effect? - a randomized, blinded, paired study in healthy volunteers.

    Summary
    EudraCT number
    		 2014-005640-18
    Trial protocol
    		 DK  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SM1-JH-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Lykkebaekvej 1, Koege, Denmark, 4600
    Public contact
    Clinical trials information, Køge Sygehus, 0045 60610666, Hessel@dadlnet.dk
    Scientific contact
    Clinical trials information, Køge Sygehus, 0045 60610666, Hessel@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
    01 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether clonidine as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block when controlling for a systemic effect
    Protection of trial subjects
    All nerve blocks were performed by a trained anesthesiologist
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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
    Denmark: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients very healthy volunteers recruited in the medical School of Copenhagens medical bulletin.

    Pre-assignment
    Screening details
    		 Eligible volunteers were males, more than 18 years old, and had American Society of Anesthesiologists physical status I. Exclusion criteria were inability to read and speak Danish, allergies to the involved drugs, weekly alcohol consumption of more than 21 units, medical abuse, use of any analgesics within 48 h or consumption of opioids within

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ropi + clonidine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    100ug perineurally co-administered with ropivacaine

    Arm title
    		 Ropivacaine + placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    1 ml saline

    Number of subjects in period 1
    		Ropi + clonidine Ropivacaine + placebo
    Started
    21
    21
    Completed
    21
    21
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ropivacaine + clonidine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    100ug perineurally co-administered with ropivacaine

    Arm title
    		 Ropivacaine + placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    1 ml saline

    Number of subjects in period 2
    		ropivacaine + clonidine Ropivacaine + placebo
    Started
    21
    21
    Completed
    21
    21

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 42 42
    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)
    		 23 ± 2 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 42 42

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Ropi + clonidine
    Reporting group description
    		 -

    Reporting group title
    Ropivacaine + placebo
    Reporting group description
    		 -
    Reporting group title
    ropivacaine + clonidine
    Reporting group description
    		 -

    Reporting group title
    Ropivacaine + placebo
    Reporting group description
    		 -

    Primary: duration of sensory nerve block assessed by temperature discrimination

    		 Close Top of page
    End point title
    		 duration of sensory nerve block assessed by temperature discrimination
    End point description
    End point type
    Primary
    End point timeframe
    0-48h
    End point values
    		 ropivacaine + clonidine Ropivacaine + placebo
    Number of subjects analysed
    21
    21
    Units: hours
        arithmetic mean (confidence interval 95%)
    19.4 (18.2 to 20.6)
    19.3 (18.2 to 20.4)
    Statistical analysis title
    		 paired t test
    Comparison groups
    Ropivacaine + placebo v ropivacaine + clonidine
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    0-48h
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    all participants
    Reporting group description
    		 -

    Serious adverse events
    		 all participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 all participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 42 (9.52%)
    Cardiac disorders
    bradycardia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    fall
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1

    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/28880902
    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-Mon Apr 29 00:43:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA