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    Clinical Trial Results:
    Ultrasoundguided Transmuscular Quadratus Lumborum(TQL) block for percutaneous nephrolithotomy (PNL) - a randomized controlled trial

    Summary
    EudraCT number
    		 2015-004770-16
    Trial protocol
    		 DK  
    Global end of trial date
    30 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PNL_protocol_v01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand university hospital Roskilde
    Sponsor organisation address
    Sygehus vej 10, Roskilde, Denmark, 4000
    Public contact
    Jens Børglum, Dept of Anest. Copenhagen University Hospital - Roskilde, +45 30700120, jedn@regionsjaelland.dk
    Scientific contact
    Jens Børglum, Dept of Anest. Copenhagen University Hospital - Roskilde, +45 30700120, jedn@regionsjaelland.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 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate whether a unilateral USG TQL block can reduce opioid consumption with clinical significance in PNL-patients.
    Protection of trial subjects
    All patients received thoroughly information prior to inclusion. They all received a PCA pump in the postoperative period
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2016
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    43
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patient scheduled for elective PNL operation were invited to participate in the study.the patients were screened for inclusion and exclusion criteria. Thereafter the patients received oral and written information prior to enrollment.

    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
    		 Investigator, Monitor, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Unilateral TQL block with 0.75% ropivacaine 30 ml
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    45010
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    30 ml 0.75% ropivacain injected between QL and PM muscle

    Arm title
    		 Control
    Arm description
    		 Received a TQL block with 30 ml of saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    B05BB01
    Other name
    Saline
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    30 ml saline 0.9% injected between QL and PM muscle

    Number of subjects in period 1
    		Active Control
    Started
    30
    30
    Completed
    25
    26
    Not completed
    5
    4
         Physician decision
    4
    3
         Consent withdrawn by subject
    1
    -
         staff strike
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Unilateral TQL block with 0.75% ropivacaine 30 ml

    Reporting group title
    Control
    Reporting group description
    		 Received a TQL block with 30 ml of saline

    Reporting group values
    		 Active Control Total
    Number of subjects
    		 30 30 60
    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 (full range (min-max))
    		 58.5 (29 to 82) 61.7 (34 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 14 15 29
        Male
    		 16 15 31

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Unilateral TQL block with 0.75% ropivacaine 30 ml

    Reporting group title
    Control
    Reporting group description
    		 Received a TQL block with 30 ml of saline

    Primary: OME 0-6 postoperative hours

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    End point title
    		 OME 0-6 postoperative hours
    End point description
    End point type
    Primary
    End point timeframe
    0-6 hours
    End point values
    		 Active Control
    Number of subjects analysed
    25
    26
    Units: mg
    7
    90
    Statistical analysis title
    		 t- test
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Any events
    Reporting group description
    		 -

    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Any events Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Any events Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 58 (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: There were no adverse events reported regarding ropivacaine

    More information

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    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/31153628
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    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.

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