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    Clinical Trial Results:
    A comparison between continuous systemic Lidocain and patient controlled intravenous morphine administration for pain control after posterior spinal fusion (PSF) in adolescent idiopatic scoliosis (AIS)

    Summary
    EudraCT number
    		 2012-005264-98
    Trial protocol
    		 BE  
    Global end of trial date
    12 Aug 2015

    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
    GDW112012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    herestraat, Leuven, Belgium,
    Public contact
    Anesthesia research, University Hospitals Leuven, 32 16344620, christel.huygens@uzleuven.be
    Scientific contact
    Anesthesia research, University 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
    12 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is the peri- and postoperative administration of lidocaine an effective traetment to reduce postoperative pain after scoliosis surgery of Adolescent idiopathic scoliosis.
    Protection of trial subjects
    The study medication was administered to patients with default hemodynamic monitoring in the setting of a completely equipped operation theatre. This enabled immediate detection and management of potential adverse events. Administration of study drugs was to be immediately stopped in case that the study subject showed signs of systemic toxicity (metallic taste, tinnitus, headache, seizure activity and ECG irregularities). Also after leaving the operation room, all patients were closely monitored for the occurrence of eventual (severe) adverse events. Postoperative pain and distress was monitored and treated as described in the protocol. The Visual Analogue Scale (VAS) was used to assess pain and adequate pain treatment was provided.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2013
    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: 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)
    28
    Adults (18-64 years)
    34
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 140 patients were assessed for eligibilty, 70 patients were enrolled and randomized between September 2013 and July 2015.

    Pre-assignment
    Screening details
    		 70 patients scheduled for posterior arthrodesis were enrolled in this prospective, randomised, double-blind, placebo-controlled clinical trial placebo group n=34 (1 patient partial loss of follow up) lidocaine group n=35

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lidocaine-group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    Patients in the lidocaine-group were given an intravenous (IV) bolus injection of lidocaine 1.5 mg/kg at induction of anaesthesia and then a continuous infusion of 1.5 mg/kg.h which was continued until 6 hours after arrival at the PACU (postoperative care unit).

    Arm title
    		 Placebo-group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    Patients in the placebo-group were given an intravenous (IV) bolus injection of saline at induction of anaesthesia and then a continuous infusion which was continued until 6 hours after arrival at the PACU.

    Number of subjects in period 1
    		Lidocaine-group Placebo-group
    Started
    35
    35
    Completed
    35
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lidocaine-group
    Reporting group description
    		 -

    Reporting group title
    Placebo-group
    Reporting group description
    		 -

    Reporting group values
    		 Lidocaine-group Placebo-group Total
    Number of subjects
    		 35 35 70
    Age categorical
    Lidocaine(year) (n=35) 49 [15; 56] Placebo(year) (n=35) 46 [16; 57] age between 12 and 75 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))
    		 49 (15 to 56) 46 (16 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 21 27 48
        Male
    		 14 8 22
    ASA class
    Units: Subjects
        ASA 1
    		 12 11 23
        ASA 2
    		 22 24 46
        ASA 3
    		 1 0 1
    weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 59.0 (50 to 84) 62.5 (52 to 79) -

    End points

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    End points reporting groups
    Reporting group title
    Lidocaine-group
    Reporting group description
    		 -

    Reporting group title
    Placebo-group
    Reporting group description
    		 -

    Primary: Cumulative morphine usage

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    End point title
    		 Cumulative morphine usage
    End point description
    Total usage of morphine during the first 24 hours postoperatively
    End point type
    Primary
    End point timeframe
    24 hours after surgery
    End point values
    		 Lidocaine-group Placebo-group
    Number of subjects analysed
    35
    35
    Units: milligram(s)
        arithmetic mean (standard deviation)
    47.7 ( 22.58 )
    51.2 ( 19.26 )
    Statistical analysis title
    		 Mean cumulative morphine usage
    Comparison groups
    Lidocaine-group v Placebo-group
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.215
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Postoperative nausea and vomiting

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    End point title
    		 Postoperative nausea and vomiting
    End point description
    End point type
    Secondary
    End point timeframe
    Day of surgery, day 1,2 and 3 after surgery
    End point values
    		 Lidocaine-group Placebo-group
    Number of subjects analysed
    35
    34
    Units: Number
        Vomiting
    6
    4
        Nausea
    23
    21
    Statistical analysis title
    		 Occurance of postoperative nausea and vomiting
    Comparison groups
    Lidocaine-group v Placebo-group
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.805
    Method
    		 Fisher exact
    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
    		 Lidocaine-group Placebo-group
    Number of subjects analysed
    35
    35
    Units: unit(s)
    median (inter-quartile range (Q1-Q3))
        Demanded
    117 (61 to 209)
    115 (66 to 159)
        Delivered
    71 (46 to 131)
    69 (40 to 101)
    Statistical analysis title
    		 Demanded boli
    Comparison groups
    Placebo-group v Lidocaine-group
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.47
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until day 3 after surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Lidocaine-group
    Reporting group description
    		 -

    Reporting group title
    Placebo-group
    Reporting group description
    		 -

    Serious adverse events
    		 Lidocaine-group Placebo-group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 35 (11.43%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Dural tap
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lidocaine-group Placebo-group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 35 (91.43%)
    31 / 35 (88.57%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 35 (40.00%)
    8 / 35 (22.86%)
         occurrences all number
    22
    22
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    25 / 35 (71.43%)
    27 / 35 (77.14%)
         occurrences all number
    52
    52

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2013
    Pharmocokinetic sampling for lidocaine
    09 Jul 2013
    Quality of life questionnaire (SF-12) during screening and one month after surgery.
    17 Dec 2013
    Study participant age from 18 - 75 years. Incorportation of ECG pre-operative, at arrival PACU and 24hr postoperatively (Safety measurement).

    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/28403408
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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
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