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    Clinical Trial Results:
    Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colon surgery.

    Summary
    EudraCT number
    2014-003466-25
    Trial protocol
    DK  
    Global end of trial date
    31 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2018
    First version publication date
    13 Jul 2018
    Other versions
    Summary report(s)
    Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colo

    Trial information

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    Trial identification
    Sponsor protocol code
    13.024
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Anders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
    Sponsor organisation address
    Søndre Boulevard 29, odense, Denmark, 5000
    Public contact
    Jan Herzog, Jan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital, 0045 60709164, anders.gadegaard.jensen@rsyd.dk
    Scientific contact
    Jan Herzog, Jan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital, 0045 60709164, anders.gadegaard.jensen@rsyd.dk
    Sponsor organisation name
    Anders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
    Sponsor organisation address
    Søndre Boulevard 29, Odense C, Denmark, 5000
    Public contact
    Anders Gadegaard Jensen, Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., Anders Gadegaard Jensen, Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., 0045 65413758, anders.gadegaard.jensen@rsyd.dk
    Scientific contact
    Anders Gadegaard Jensen, Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., Anders Gadegaard Jensen, Anesthesia and Intensive Care Unit, Odense University Hospital,OUH., 0045 65413758, anders.gadegaard.jensen@rsyd.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
    25 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of the trial is to investigate whether intravenous lidocaine administered perioperatively can significantly reduce postoperative morphine consumption during the first 24 hours postoperatively by robot-assisted laparoscopic colon rectal cancer surgery.
    Protection of trial subjects
    The trial participant is carefully observed during the per- and postoperative course with regard to adverse events and events both in the operating room by the anesthetic staff and in the recovery section by the staff here. If any adverse event were observed in this period, they were recorded.Procedures for recording and reporting events / adverse events: Definitions of events and side effects were divided into the following: Event: Any unwanted incident in a clinical trial after a drug with a patient or a subject without the need for a correlation between this and the unwanted event. Adverse Drug Reaction (ADR): Any adverse and undesired reaction to a trial drug regardless of dose. Unexpected adverse reaction: A side effect, whose grade or seriousness does not match the product information (product summary). Severe Incidence (SAE) or serious adverse event (SAR): An event or adverse event irrespective of dose results in death, is life threatening, causes hospitalization or prolonged hospitalization, resulting in significant or sustained disability or incapacity or leads to congenital anomaly or malformation. Unexpected and suspected serious side effects (SUSAR): suspected adverse reactions that are both unexpected and severe.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    10
    From 65 to 84 years
    40
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    We included adult, Danish speaking patients scheduled for elective robot-assisted laparoscopic colorectal surgery. Exclusion criteria were: allergy for amide localanalgetics, atrioventricular blocks, hepatic- (ALAT, ASAT or bilirubin > 2,5 x upper limit), or renal failure (calculated CrCl<60ml/min), chronic use of opioids or NSAID'S, pregnant or la

    Pre-assignment
    Screening details
    We included adult, Danish speaking patients scheduled for elective robot-assisted laparoscopic colorectal surgery. Exclusion criteria were: allergy for amide localanalgetics, atrioventricular blocks, hepatic- (ALAT, ASAT or bilirubin > 2,5 x upper limit), or renal failure (calculated CrCl<60ml/min), chronic use of opioids or NSAID'S, pregnant or la

    Period 1
    Period 1 title
    Randomized, double-blind, prospective, p (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention
    Arm description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline.
    Arm type
    Experimental

    Investigational medicinal product name
    lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Before anesthesia induction we gave an equal volume of blinded study medication according to 1,5mg/kg bolus from a solution of 0,5% lidocaine with a rate of 300ml/h. Thereafter we started the continuing infusion of the same volume per hour throughout the surgery ending in the PACU 2 hours after end of surgery. A 70kg patient would get 21ml study medication (either isotonic saline or 0,5% lidocaine) as a bolus and 21ml/h until 2 hours after end of surgery.

    Arm title
    placebo
    Arm description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline
    Arm type
    Placebo

    Investigational medicinal product name
    hypotonic saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Before anesthesia induction we gave an equal volume of blinded study medication according to 1,5mg/kg bolus from a solution of 0,5% lidocaine with a rate of 300ml/h. Thereafter we started the continuing infusion of the same volume per hour throughout the surgery ending in the PACU 2 hours after end of surgery. A 70kg patient would get 21ml study medication (either isotonic saline or 0,5% lidocaine) as a bolus and 21ml/h until 2 hours after end of surgery

    Number of subjects in period 1
    Intervention placebo
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomized, double-blind, prospective, p
    Reporting group description
    -

    Reporting group values
    Randomized, double-blind, prospective, p Total
    Number of subjects
    60 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    10 10
        From 65-84 years
    40 40
        85 years and over
    10 10
    Age continuous
    Units: years
        median (standard deviation)
    30 ± 30 -
    Gender categorical
    Units: Subjects
        Female
    20 20
        Male
    40 40
    Subject analysis sets

    Subject analysis set title
    We randomized 60 patients in this prospective, randomized, dou
    Subject analysis set type
    Full analysis
    Subject analysis set description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. The follow up period was 72 hours. Primary outcome was cumulative morphine consumption at 24 hours. Secondary outcomes were cumulative morphine consumption at 72hours, numerical pain score at 24 hours/72hours, length of stay, incidence of use of antiemetics, time until flatus/defecation.

    Subject analysis sets values
    We randomized 60 patients in this prospective, randomized, dou
    Number of subjects
    58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    10
        From 65-84 years
    40
        85 years and over
    10
    Age continuous
    Units: years
        median (standard deviation)
    29 ± 29
    Gender categorical
    Units: Subjects
        Female
    18
        Male
    40

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline.

    Reporting group title
    placebo
    Reporting group description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline

    Subject analysis set title
    We randomized 60 patients in this prospective, randomized, dou
    Subject analysis set type
    Full analysis
    Subject analysis set description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline. The follow up period was 72 hours. Primary outcome was cumulative morphine consumption at 24 hours. Secondary outcomes were cumulative morphine consumption at 72hours, numerical pain score at 24 hours/72hours, length of stay, incidence of use of antiemetics, time until flatus/defecation.

    Primary: The primary outcome

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    End point title
    The primary outcome
    End point description
    End point type
    Primary
    End point timeframe
    The primary outcome was cumulative morphine consumption at 24hrs after end of surgery.
    End point values
    Intervention placebo We randomized 60 patients in this prospective, randomized, dou
    Number of subjects analysed
    30
    30
    58
    Units: cumulative morphine consumption at 24hrs
        number (not applicable)
    29
    29
    58
    Statistical analysis title
    The primary outcome
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Post-hoc
    Analysis type
    other [1]
    P-value
    < 0.05
    Method
    Regression, Linear
    Confidence interval
    Notes
    [1] - Power calculation was done in advance assuming 30% reduction in morphine consumption (based on prior studies by other groups) in the lidocaine group. We needed a power of 80% to detect a difference defined by a p<0,05. According to this calculation we needed 49 patients and decided to include 60 considering there might be dropouts. The data was analyzed according to the intention-to-treat principle.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From arriving to the operating theatre until 72 hours after conclusion the surgery.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    GCP
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline.

    Reporting group title
    placebo
    Reporting group description
    We randomized 60 patients in this prospective, randomized, double blinded trial. The patients were treated with 1,5mg/kg bolus and afterwards 1,5mg/kg/h infusion of lidocaine from before anesthesia induction until 2 hours after end of surgery. The control group received an equal volume of isotonic saline

    Serious adverse events
    Intervention placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (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: 0%
    Non-serious adverse events
    Intervention placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (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: We did not register any non-serious adverse event in the intervention group.

    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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