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    Clinical Trial Results:
    Transversus abdominis plane blok, continous systemic administration of lidocain and patient controlled intravenous morphine - 3 methods for postoperative pain control after laparoscopic colorectal surgery: a randomised comparative trial.

    Summary
    EudraCT number
    		 2014-001499-73
    Trial protocol
    		 BE  
    Global end of trial date
    16 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GDW04/2014Amendment1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Univeristy Hospitals Leuven
    Sponsor organisation address
    herestraat, leuven, Belgium,
    Public contact
    Anesthesie Research, Univeristy Hospitals Leuven, +32 16344620, christel.huygens@uzleuven.be
    Scientific contact
    Anesthesie Research, Univeristy Hospitals Leuven, +32 16344620, 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
    17 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does a TAP-block offers superior analgesia in comparison with systemic administation of linisol after laparoscopic colo-rectal surgery.
    Protection of trial subjects
    To prevent patient discomfort and distress, adequate follow-up and treatment was described in the protocol. "Postoperative pain in the PACU and on the ward was treated with acetaminophen (15 mg/kg 4/day) and ketorolac (0.5mg/kg 3/day) using a fixed scheme. In addition, each patient received patient-controlled intravenous analgesia (PCIA) with morphine. If the postoperative numeric rating scale (NRS) for pain exceeded 3, an additional bolus of 1 mg of morphine (IV) was given on the PACU. If pain treatment was still insufficient, a clonidine bolus (1µg/kg) was given. PONV prophylaxis was performed with IV dexamethasone and IV ondansetron. PONV rescue treatment consisted of IV-droperidol (PACU) or IV-ondansetron (on the ward)."
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2014
    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: 125
    Worldwide total number of subjects
    125
    EEA total number of subjects
    125
    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)
    87
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 between December 2014 and January 2017

    Pre-assignment
    Screening details
    		 125 patients undergoing laparoscopic colorectal surgery were included in this randomized, double-blind controlled clinical trial, patients were randomly allocated to either the quadratus lumborum group (QL-group)(n=50), the lidocaine group (L-group)(n=50) or the placebo group (P-group)(n=25)

    Pre-assignment period milestones
    Number of subjects started
    		 125
    Number of subjects completed
    		 125

    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
    Blinding implementation details
    To attain blinding of the patients and the investigators, patients in the QL-group and the P-group received a perioperative placebo infusion with saline at the same rate as the lidocaine infusion in the L-group. Moreover, the patients of both the L-group and the P-group received also a QL-block with saline.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QL-group
    Arm description
    		 Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    In patients of the QL-group, a bilateral single shot QL-block was applied under ultrasound guidance before induction of anesthesia. At each side, 30 mL (in patients weighing > 55 kg) or 20 mL (in patients weighing < 55 kg) of ropivacaine 0.25% and clonidine 0.5 µg kg-1 were injected using a 22G needle of 50mm length.

    Arm title
    		 L-group
    Arm description
    		 Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in the L-group received an intravenous (IV) bolus injection of lidocaine 1.5 mg kg 1 at induction of anesthesia followed by a continuous infusion of 1.5 mg kg-1h-1 which was continued until 4h after arrival at the postoperative anesthesia care unit (PACU).

    Arm title
    		 Control
    Arm description
    		 Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Perineural use, Intravenous use
    Dosage and administration details
    To attain blinding of the patients and the investigators, patients in the QL-group and the P-group received a perioperative placebo infusion with saline at the same rate as the lidocaine infusion in the L-group. Moreover, the patients of both the L-group and the P-group received also a QL-block with saline.

    Number of subjects in period 1
    		QL-group L-group Control
    Started
    50
    50
    25
    Completed
    50
    50
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QL-group
    Reporting group description
    		 Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg

    Reporting group title
    L-group
    Reporting group description
    		 Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo)

    Reporting group title
    Control
    Reporting group description
    		 Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group).

    Reporting group values
    		 QL-group L-group Control Total
    Number of subjects
    		 50 50 25 125
    Age categorical
    age between 18 and 75 years Quadratus lumborum (n=50) 56 (48; 65) years lidocaine : (n=50) 60 (49; 68) years Placebo : (n=25) 62 (59;68) years
    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
        median (inter-quartile range (Q1-Q3))
    		 59 (47.75 to 64.75) 60 (48 to 67.75) 62 (59 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 18 23 11 52
        Male
    		 32 27 14 73
    ASA
    ASA classification
    Units: Subjects
        ASA 1
    		 8 9 7 24
        ASA 2
    		 34 30 14 78
        ASA 3
    		 8 11 4 23
    Weight
    Units: kilogram(s)
        median (inter-quartile range (Q1-Q3))
    		 80 (69 to 90) 75 (64 to 81) 72 (67 to 86) -
    BMI
    Units: kilogram(s)/square meter
        median (inter-quartile range (Q1-Q3))
    		 26.4 (23.9 to 29.4) 25 (23 to 27.2) 25.4 (24.2 to 28.4) -
    Height
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 171 (168 to 180) 170 (165 to 178) 169 (165 to 175) -

    End points

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    End points reporting groups
    Reporting group title
    QL-group
    Reporting group description
    		 Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg

    Reporting group title
    L-group
    Reporting group description
    		 Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo)

    Reporting group title
    Control
    Reporting group description
    		 Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group).

    Primary: Cumulative morphine usage

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    End point title
    		 Cumulative morphine usage
    End point description
    End point type
    Primary
    End point timeframe
    24 hours after surgery
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: milligram(s)
        arithmetic mean (standard deviation)
    37.5 ( 28.4 )
    40.2 ( 25 )
    21.8 ( 17 )
    Statistical analysis title
    		 Cumulative morphine consumption
    Statistical analysis description
    Cumulative morphine consumption the first 24 hours postoperatively
    Comparison groups
    QL-group v L-group
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.15
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Recovery of bowel movement

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    End point title
    		 Recovery of bowel movement
    End point description
    Time until defecation
    End point type
    Secondary
    End point timeframe
    Day of discharge (chart review)
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: day
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    3 (2 to 4)
    3 (2 to 5)
    Statistical analysis title
    		 Time until defecation
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.84
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incidence of postoperative nausea and vomiting

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    End point title
    		 Incidence of postoperative nausea and vomiting
    End point description
    Incidence of PONV during first 24 hours postoperatively
    End point type
    Secondary
    End point timeframe
    24 hours after surgery
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: number
        PONV: yes
    30
    35
    16
        PONV: No
    20
    15
    9
    Statistical analysis title
    		 incidence of PONV
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.578
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Lenght of hospital stay

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    End point title
    		 Lenght of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    Day of discharge
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: day
        median (inter-quartile range (Q1-Q3))
    4 (3 to 5)
    4 (4 to 5)
    4 (3 to 5)
    Statistical analysis title
    		 Length of hospital stay
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.73
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clavien-Dindo Classification

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    End point title
    		 Clavien-Dindo Classification
    End point description
    Inhospital morbidity with the Clavien Dindo classification
    End point type
    Secondary
    End point timeframe
    Day of discharge
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 1)
    0 (0 to 0.75)
    0 (0 to 1)
    Statistical analysis title
    		 Clavien Dindo classification
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.908
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cytokine IL-6 day 1

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    End point title
    		 Cytokine IL-6 day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 after surgery
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    15 (7 to 37)
    19 (11 to 39)
    36 (5 to 72)
    Statistical analysis title
    		 Cytokine IL-6 Day 1
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.52
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: CRP

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    End point title
    		 CRP
    End point description
    C-reactive protein as inflammatory parameter at postoperative day 1
    End point type
    Secondary
    End point timeframe
    Day 1 after surgery
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: milligram(s)/millilitre
        median (inter-quartile range (Q1-Q3))
    35 (17 to 55)
    42 (23 to 68)
    27 (19 to 50)
    Statistical analysis title
    		 CRP day 1
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.31
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total number of morphine boli

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    End point title
    		 Total number of morphine boli
    End point description
    End point type
    Secondary
    End point timeframe
    At removal of PCIA system
    End point values
    		 QL-group L-group Control
    Number of subjects analysed
    50
    50
    25
    Units: unit(s)
    median (inter-quartile range (Q1-Q3))
        Delivered
    20 (13 to 31)
    22 (13 to 32)
    11 (5 to 22)
        Demanded
    23 (14 to 38)
    28 (14 to 49)
    12 (6 to 35)
    Statistical analysis title
    		 Delivered morphine boli
    Comparison groups
    QL-group v L-group v Control
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.005
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start: Enrollment Stop: Until hospital discharge
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    QL-group
    Reporting group description
    		 Quadratus lumborum group: patients received TAP-block with ropivacaine 0.25% and clonidine 0.5µg/kg

    Reporting group title
    L-group
    Reporting group description
    		 Lidocaine group: patients received infusion with lidocaine 1.5 mg/kg (TAP block with placebo)

    Reporting group title
    Control
    Reporting group description
    		 Placebo group, Control group: Saline was given in TAP block, Saline was given in infusion. Only PCIA with morphine (as in QL-group and L-group).

    Serious adverse events
    		 QL-group L-group Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 50 (10.00%)
    7 / 50 (14.00%)
    4 / 25 (16.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Peritonitis
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 50 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 QL-group L-group Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 50 (28.00%)
    2 / 50 (4.00%)
    6 / 25 (24.00%)
    Cardiac disorders
    Arrhythmia
    Additional description: Arrythmia as LAST (local anaesthetic systemic toxicity)
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    2
    2
    Nervous system disorders
    Metallic taste
    Additional description: Metallic taste as symptom of LAST (local anaesthetic systemic toxicity)
         subjects affected / exposed
    9 / 50 (18.00%)
    1 / 50 (2.00%)
    0 / 25 (0.00%)
         occurrences all number
    9
    1
    0
    Ear and labyrinth disorders
    Tinnitus
    Additional description: LAST (local anaesthetic systemic toxicity)
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    1 / 25 (4.00%)
         occurrences all number
    5
    5
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2014
    1) Quadratus lumborum approach for TAP block 2) Time of TAP block at induction 3) Dosage of local anaesthetics 4) Timepoint blood sample 5) Serum ropivacain and lidocain measurement
    20 Jan 2015
    TAP block placement at induction with all patients (for the L-group and control, saline will be used)
    22 Dec 2015
    Lidocain determination on tissue that was isolated during surgery.

    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/30004914
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