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   44237   clinical trials with a EudraCT protocol, of which   7338   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:
    Quadratus lumborum 3 block (QLB3) for laparoscopic colorectal surgery: A double blind, prospective randomized placebo-controlled trial.

    Summary
    EudraCT number
    		 2019-002304-40
    Trial protocol
    		 BE  
    Global end of trial date
    24 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Aug 2023
    First version publication date
    19 Aug 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SC05-2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium,
    Public contact
    anesthesiology research, University hospitals Leuven, christel.huygens@uzleuven.be
    Scientific contact
    anesthesiology research, University hospitals Leuven, christel.huygens@uzleuven.be
    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
    12 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study is to improve pain management, minimize the need for postoperative opioids and to facilitate postoperative recovery after laparoscopic colorectal surgery. Our hypothesis is that a bilateral single shot QLB 3 block with 30mL ropivacaine 0,375% on each side is associated with a reduction in postoperative morphine consumption as compared to normal saline 0,9%. Superiority of the QLB 3 block will be defined as a 30% reduction in the cumulative 24-hour morphine consumption post-surgery.
    Protection of trial subjects
    Postoperatively, all patients received multimodal intravenous analgesia including paracetamol, ketorolac and patient-controlled analgesia (PCIA) with morphine. Rescue medication consisted of clonidine, metamizole and ketamine. Patiënts received PCIA up unto 24 hours after surgery. Paracetamol and morphine was given after stopping PCIA. Follow-up till discharge and evaluation of pain scores were standardised.-surgery.
    Background therapy
    		 Irrespective of any group allocation every patient received 0.1-0.2 mg/kg morphine at extubation and end surgery. At transfer PACU after surgery all patients received the PCIA and with evaluation of painscores extra clinical bolus of Morphine 2 mg was given if NRS > 4 All standard multimodal analgesia was given (ketorolac, paracetamol)
    Evidence for comparator
    		 No big multicenter trails were conducted yet to evaluate the QLB in laparoscopic colorectal surgery. A few small trials however detected advantage in caesarian section and kidney surgery. Given the anatomic basis and the possibility to give analgesia over a larger portion of the abdominal wall, investigation seems mandatory
    Actual start date of recruitment
    16 Sep 2019
    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
    Belgium: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    84
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 From november 29, 2019 till 21st of July 2022 a total of 173 patients were screened in Leuven and 158 in Kortrijk. Eventually 150 patients were enrolled, 100 in Leuven and 50 in Kortrijk.

    Pre-assignment
    Screening details
    		 all consecutive patients between 18 and 75 years of age scheduled for elective laparoscopic colorectal surgery were screened for potential enrolment. Inclusion criteria were American Society of Anesthesiologists (ASA) classification of physical status I-III, a body mass index (BMI) ≤ 35, and the ability to understand the use of PCIA

    Period 1
    Period 1 title
    Surgery (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Patients were randomized using a computer-generated permuted block randomization sequence (variable block size with 1:1 allocation). Enclosing assignments in opaque, sequentially numbered, sealed envelopes ensured allocation concealment. Prior to anesthesia, upon arrival in the preoperative holding area, the randomization envelope was opened and medication was prepared by an independent member of the research team not involved in the study or subject’s care. Syringes labeled as trial medication

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375% at QLB interfascial plane

    Arm title
    		 Control
    Arm description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2x30ml normal saline 0,9% at QLB interfascial plane

    Number of subjects in period 1
    		Intervention Control
    Started
    75
    75
    Completed
    75
    75

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%.

    Reporting group title
    Control
    Reporting group description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 75 75 150
    Age categorical
    Adult ages were included
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 46 49 95
        From 65-84 years
    		 29 26 55
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 37 32 69
        Male
    		 38 43 81
    Subject analysis sets

    Subject analysis set title
    Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysing QLB on postoperative pain

    Subject analysis set title
    Intervention
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The coefficient of variation (CV) in postoperative morphine consumption was assumed to equal 0.7 and derived from own data.[6] To have 80% power to show a 30% reduction in the 24-h consumption in the ropivacaine group versus the placebo group using a two-sided test for a ratio of means (with alpha = 5%), at least 51 patients per group were needed (i.e., 102 patients in total). The total number of subjects was increased to 128 to have also at least 80% power in a secondary analysis to detect an effect of ropivacaine within the subgroup of patients with a BMI ≤ 30 (this group was expected to constitute 80% of the total sample). In order to compensate for possible dropouts we included 150 patients in total.

    Subject analysis sets values
    		 Control Intervention
    Number of subjects
    75
    75
    Age categorical
    Adult ages were included
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    46
    49
        From 65-84 years
    29
    26
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    37
    32
        Male
    40
    43

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed either 2x30 ml on each side ropivacaine 0,375%.

    Reporting group title
    Control
    Reporting group description
    		 The bilateral AQLB was placed before induction of anesthesia. The patient was first positioned in the left and then in the right lateral decubitus position. A total of 60 ml was placed 2x30ml normal saline 0,9% at the QLB fascia plane

    Subject analysis set title
    Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysing QLB on postoperative pain

    Subject analysis set title
    Intervention
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The coefficient of variation (CV) in postoperative morphine consumption was assumed to equal 0.7 and derived from own data.[6] To have 80% power to show a 30% reduction in the 24-h consumption in the ropivacaine group versus the placebo group using a two-sided test for a ratio of means (with alpha = 5%), at least 51 patients per group were needed (i.e., 102 patients in total). The total number of subjects was increased to 128 to have also at least 80% power in a secondary analysis to detect an effect of ropivacaine within the subgroup of patients with a BMI ≤ 30 (this group was expected to constitute 80% of the total sample). In order to compensate for possible dropouts we included 150 patients in total.

    Primary: Morphine consumption 24 hours

    		 Close Top of page
    End point title
    		 Morphine consumption 24 hours
    End point description
    Primary outcome was the cumulative morphine consumption during the first 24 hours after extubation. Secondary outcomes included severity of pain, presence/extent of sensory block, the incidence of post-operative nausea and vomiting as well as recovery and hospital length of stay. We also investigated the need for and dose of rescue analgesia. Safety outcomes included the incidence of adverse events.
    End point type
    Primary
    End point timeframe
    Morphine during the first 24 hours using PCIA
    End point values
    		 Intervention Control
    Number of subjects analysed
    75
    75
    Units: mg
        median (inter-quartile range (Q1-Q3))
    28.6 (9 to 39)
    28.4 (12 to 39.1)
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - For the primary outcome, a two-sided independent t-test was used for the difference as well as for for the ratio of the geometric means to compare the 24-h cumulative morphine intake between both groups. A 95% confidence interval for the difference and for the ratio of the geometric means was reported. Secondary outcomes were compared using Fisher’s exact test for proportions, and Mann-Whitney U tests were used when data were measured on a ratio or ordinal level. P-values smaller than 0.05 were

    Secondary: Pain scores

    		 Close Top of page
    End point title
    		 Pain scores
    End point description
    End point type
    Secondary
    End point timeframe
    NRS pain scores during 4 hour time frame in PACU and the wards untill discharge
    End point values
    		 Intervention Control Control Intervention
    Number of subjects analysed
    75
    75
    75
    75
    Units: NRV units
    75
    75
    75
    75
    No statistical analyses for this end point

    Secondary: Safety

    		 Close Top of page
    End point title
    		 Safety
    End point description
    End point type
    Secondary
    End point timeframe
    All adverse events and safety points (nausea, redo surgery, bleeding, systemic toxicity)
    End point values
    		 Intervention Control Control Intervention
    Number of subjects analysed
    75
    75
    75
    75
    Units: Complication events
    41
    40
    41
    40
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From enrollment until discharge of the patient
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Before induction of anesthesia, patients received a bilateral AQLB in the left and right lateral decubitus position under ultrasound guidance 30 ml of either ropivacaine 0.375% (n=75)

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 75 (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
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 75 (26.67%)
    20 / 75 (26.67%)
    Gastrointestinal disorders
    postopertaive nausea, vomiting and ileus
         subjects affected / exposed
    20 / 75 (26.67%)
    20 / 75 (26.67%)
         occurrences all number
    20
    20

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2022
    Amendment 1 and 2 Adding extra center (Kortrijk) Increasing age Adjusting inclusion criteria (ifo Liver and kidney function)

    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA