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

    Summary
    EudraCT number
    		 2017-004593-34
    Trial protocol
    		 DK  
    Global end of trial date
    27 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2021
    First version publication date
    24 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2017-070
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ZUH, Roskilde
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Jens Børglum, Dept. of Anesth. Zealand University Hospital Roskilde, +45 30700120, jedn@regionsjaelland.dk
    Scientific contact
    Jens Børglum, Dept. of Anesth. Zealand 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 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Aim: Our aim with this study is to investigate the efficacy of the Ultrasound-guided (USG) Transmuscular Quadratus Lumborum (TQL) block vs. Placebo in patients undergoing Total Laparoscopic Hysterectomy (TLH). Our hypothesis is that the bilateral TQL block will significantly reduce the opioid consumption during the first 12 postoperative hours.
    Protection of trial subjects
    Participants were closely monitores by study assistants and got at least the standard of care of the department
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2018
    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: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    40
    From 65 to 84 years
    28
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 70 subjects were enrolled at Zealand University Hospital, Denmark from September 28 2018 to November 8 2019.

    Pre-assignment
    Screening details
    		 140 subjects were assessed for elgibility. Most of those excluded was due to 'declined to participate'

    Pre-assignment period milestones
    Number of subjects started
    		 70
    Number of subjects completed
    		 70

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active
    Arm description
    		 TQL block with active medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Bilateral transmuscular quadratus lumborum block. 2 x 30 mL ropivacaine 0.375% (3.75 mg/mL with each block (bilateral)) = 225 mg in total.

    Arm title
    		 Control, NaCl
    Arm description
    		 TQL block bilateral with in-active substance (NaCl) in the same volume of 30 mL at each side.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    TQL blocks were administered with 30 ml of isotonic saline (NaCl) injected at each side

    Number of subjects in period 1
    		active Control, NaCl
    Started
    35
    35
    Completed
    35
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    active
    Reporting group description
    		 TQL block with active medication.

    Reporting group title
    Control, NaCl
    Reporting group description
    		 TQL block bilateral with in-active substance (NaCl) in the same volume of 30 mL at each side.

    Reporting group values
    		 active Control, NaCl Total
    Number of subjects
    		 35 35 70
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 19 40
        From 65-84 years
    		 13 15 28
        85 years and over
    		 1 1 2
    Gender categorical
    Units: Subjects
        Female
    		 35 35 70
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    active
    Reporting group description
    		 TQL block with active medication.

    Reporting group title
    Control, NaCl
    Reporting group description
    		 TQL block bilateral with in-active substance (NaCl) in the same volume of 30 mL at each side.

    Primary: cumulated oral morphine equivalent consumption (mg)

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    End point title
    		 cumulated oral morphine equivalent consumption (mg)
    End point description
    Opioid usage from patient-controlled analgesia - pump and supplemental opioids administered by the nurses of the postoperative care or ward, All reported as cumulated oral morphine equivalents.
    End point type
    Primary
    End point timeframe
    The first 12 postoperative hours
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: miligram
    58
    64
    Attachments
    		 Results table from TQL TLH in RAPM
    Statistical analysis title
    		 Student’s unpaired t-test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Oral morphine equivalents in mg, 0–6 hours

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    End point title
    		 Oral morphine equivalents in mg, 0–6 hours
    End point description
    End point type
    Secondary
    End point timeframe
    0-6 hors postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: mg
    56
    59
    Statistical analysis title
    		 Student’s unpaired t-test.
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Oral morphine equivalents 6-12

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    End point title
    		 Oral morphine equivalents 6-12
    End point description
    End point type
    Secondary
    End point timeframe
    6-12 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: mg
    0
    0
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Oral morphine equivalents 12–18 hours

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    End point title
    		 Oral morphine equivalents 12–18 hours
    End point description
    End point type
    Secondary
    End point timeframe
    12-18 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: mg
    0
    0
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Oral morphine equivalents 18-24

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    End point title
    		 Oral morphine equivalents 18-24
    End point description
    End point type
    Secondary
    End point timeframe
    12-18 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: mg
    0
    0
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Oral morphine equivalents 0-24 hours

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    End point title
    		 Oral morphine equivalents 0-24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: mg
    63
    69
    Statistical analysis title
    		 Student’s unpaired t-test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: median NRS at rest 0-6

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    End point title
    		 median NRS at rest 0-6
    End point description
    End point type
    Secondary
    End point timeframe
    0-6 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: NRS units
    4
    4
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: median NRS at rest 6-12 hours

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    End point title
    		 median NRS at rest 6-12 hours
    End point description
    End point type
    Secondary
    End point timeframe
    6-12 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: NRS units
    1
    1
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: median NRS at rest 12-18 hours

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    End point title
    		 median NRS at rest 12-18 hours
    End point description
    End point type
    Secondary
    End point timeframe
    12-18 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: NRS units
    1
    1
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: median NRS at rest 18-24 hours

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    End point title
    		 median NRS at rest 18-24 hours
    End point description
    End point type
    Secondary
    End point timeframe
    18-24 hours postoperatively
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: NRS units
    0
    1
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median NRS score during block performance

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    End point title
    		 Median NRS score during block performance
    End point description
    End point type
    Secondary
    End point timeframe
    regsitered immediately after block performance
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    35
    Units: NRS units
    2
    2
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mean time to first sitting up in bed

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    End point title
    		 Mean time to first sitting up in bed
    End point description
    End point type
    Secondary
    End point timeframe
    During followup of up to 24 hours.
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: minutes
    217
    254
    Statistical analysis title
    		 Student’s unpaired t-test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Time to first opioid in minutes

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    End point title
    		 Time to first opioid in minutes
    End point description
    End point type
    Secondary
    End point timeframe
    Time during follow-up of up to 24 hours.
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    27
    28
    Units: minutes
    12
    15
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time to first ambulation

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    End point title
    		 Time to first ambulation
    End point description
    End point type
    Secondary
    End point timeframe
    Time during follow-up of up to 24 hours.
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: minutes
    283
    298
    Statistical analysis title
    		 Student’s unpaired t-test
    Comparison groups
    active v Control, NaCl
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: PONV during follow-up

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    End point title
    		 PONV during follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    Time during follow-up of up to 24 hours.
    End point values
    		 active Control, NaCl
    Number of subjects analysed
    35
    34
    Units: numbers
    16
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were closely monitored during the study period of up til 24 hours (shorter if released earlier from dep. of gynaecology). After admission ended participants were encouraged to contact study investigator/sponsor if adverse reactions occured.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    active
    Reporting group description
    		 TQL block with active medication.

    Reporting group title
    Control, NaCl
    Reporting group description
    		 TQL block bilateral with in-active substance (NaCl) in the same volume of 30 mL at each side.

    Serious adverse events
    		 active Control, NaCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (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
    		 active Control, NaCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 35 (22.86%)
    9 / 35 (25.71%)
    Nervous system disorders
    Nausea
    Additional description: The dominant adverse reaction was PONV (postoperative nausea and vomiting) with only a few productive vomiting but a substantial amount of participants experiencing nausea from the escape medication (i.v. morphine, tuypically)
         subjects affected / exposed
    8 / 35 (22.86%)
    9 / 35 (25.71%)
         occurrences all number
    8
    9

    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
    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.

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