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    Clinical Trial Results:
    Ultrasound-guided Transmuscular Quadratus Lumborum block for elective caesarean section. A double blind, randomized, placebo controlled trial.

    Summary
    EudraCT number
    		 2016-004594-41
    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
    2016-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital, Roskilde
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Jens Børglum, Dept. of Anaesthesia - Zealand University Hospital, Roskilde, +45 30700120, jens.borglum@gmail.com
    Scientific contact
    Jens Børglum, Dept. of Anaesthesia - Zealand University Hospital, Roskilde, +45 30700120, jens.borglum@gmail.com
    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 May 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 investigate the efficacy of the TQL block (reduction in use of opioids in the first 24 postoperative hours) vs. Placebo in patients undergoing elective Caesarean Section.
    Protection of trial subjects
    All participants received oral and written information before decision on participation. All participants recevived the standard pain tratment for their cesarean section. On top of the standard treatment, the intervention was made in the immediate postoperative setting, when their spinal anaesthesia was still intact, so no further discomfort was experienced. If/when participants would feel pain they would have an intravenous (IV) patient-controlled-analgesia device attached to an IV-line for immediate pain relief.
    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: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    72
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All parturients scheduled for elective cesarean section at our institution (Zealand University Hospital, Roskilde) were invited to particpate in the study. Inclusion/exclusion criteria were assessed and oral and written information was given .

    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
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Bilateral transmuscular quadratus lumborum block with 2 x 30 ml 0.375% ropivacain
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacain
    Investigational medicinal product code
    45010
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    Participants would receive 2 x 30 ml of the active substance. Ropivacaine 0.75% was diluted in a 1:1 ratio with saline in order to achieve a 0.375% concentration. 2 x 30 ml of the 0.375% concentration were injected, 30 ml on each side.

    Arm title
    		 Control
    Arm description
    		 Bilat. transmuscular quadratus lumborum block with 2 x 30 ml saline.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    B05BB01
    Other name
    NaCl, physiologic sodium-chloride
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    2 x 30 ml Saline as bilateral transmuscular quadratus lumborum block.

    Number of subjects in period 1
    		Active Control
    Started
    36
    36
    Completed
    34
    34
    Not completed
    2
    2
         Physician decision
    1
    -
         Lost to follow-up
    1
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Bilateral transmuscular quadratus lumborum block with 2 x 30 ml 0.375% ropivacain

    Reporting group title
    Control
    Reporting group description
    		 Bilat. transmuscular quadratus lumborum block with 2 x 30 ml saline.

    Reporting group values
    		 Active Control Total
    Number of subjects
    		 36 36 72
    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)
    		 32.3 ( 5.7 ) 31.5 ( 4.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 36 72
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Bilateral transmuscular quadratus lumborum block with 2 x 30 ml 0.375% ropivacain

    Reporting group title
    Control
    Reporting group description
    		 Bilat. transmuscular quadratus lumborum block with 2 x 30 ml saline.

    Primary: OME, oral morphine equivalents

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    End point title
    		 OME, oral morphine equivalents
    End point description
    Morphine consumption was recorded from the PCA-pumps (5 mg morphine IV per bolus) and with any additional administration (oral or IV) during the first 24 hour period after block application.
    End point type
    Primary
    End point timeframe
    24 hour opioid consumption
    End point values
    		 Active Control
    Number of subjects analysed
    34
    34
    Units: mg
    65
    94
    Statistical analysis title
    		 T-test
    Comparison groups
    Active v Control
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events would be expected in the immediate time after administration of blocks (minutes), but possible adverse events were recorded in the first 48 hours.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Any event related to TQL ropivacaine
    Reporting group description
    		 -

    Serious adverse events
    		 Any event related to TQL ropivacaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 70 (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
    		 Any event related to TQL ropivacaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 70 (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 a few registered non-serious adverse events recorded. Most of these (PONV) related to the administration of morphine (not study medicine) and a few other were mostly related to the spinal anaesthesia and the surgery. None of the recorded adverse events were considered related to the study medicine (ropivacaine or saline used in the TQL block).

    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
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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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