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    Clinical Trial Results:
    Pilot study: Targeting the inflammatory response after breast cancer surgery with lidocaïne and dexamethasone

    Summary
    EudraCT number
    		 2012-002222-70
    Trial protocol
    		 NL  
    Global end of trial date
    08 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jan 2021
    First version publication date
    14 Jan 2021
    Other versions
    Summary report(s)
    		 Published article

    Trial information

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    Trial identification
    Sponsor protocol code
    Lidobreast
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud University Medical Center
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525GA
    Public contact
    Head of Department Anesthesiology, Radboud University Medical Center, K.Vissers@anes.umcn.nl
    Scientific contact
    Head of Department Anesthesiology, Radboud University Medical Center, K.Vissers@anes.umcn.nl
    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
    08 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is the impact of administering intravenous lidocaïne and dexamethasone on cytokine levels.
    Protection of trial subjects
    We aimed to reduce the study burden as much as possible by performing study-measurements coupled to normal care. Pain scores at baseline and 4 hours postoperative = normal care. Blood sample for determining cytokine levels at baseline: from the iv canula which was placed before surgery. At 4 hours postoperative: 1 extra vena punction was done, or from the iv canula (if this was possible) Monitoring of studymedication, which was given during surgery and on the post operative ward. Normal respiratory, haemodynamic and neurologic monitoring was done, which could catch the side effects of lidocaine. Internal monitoring was performed at the start, during and end of each pilot study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 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
    Netherlands: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The investigations and data collection for the first study were carried out between November 2014 and March 2015, for the second study between October and December 2015, and for the third study between June and October 2016.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 55
    Number of subjects completed
    		 55

    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, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Overall study
    Arm description
    		 Overall study is pilot 1, 2 and 3 together, all patients recieved lidocaïne or placebo In pilot 1, patients received no dexamethason In pilot 3 patients received dexamethason 4 mg In pilot 3 patients recieved dexamethason 8 mg During all 3 studies the same protocol was followed In total, 55 subjects were enrolled and randomized to receive the study medication (20 subjects in study 1, 17 subjects in study 2, and 18 subjects in study 3). Seven patients were excluded for analysis for the following reasons: the pharmacy was unable to provide study medication for 2 patients (study 1, n = 1; study 3, n =1); the protocol was violated in 3 patients of study 1; the surgical procedure was changed in 1 patient in study 2, and 1 patient withdrew consent in study 3
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lidocaine Hydrochloride 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During induction of anesthesia patients will receive 1.5mg/kg intravenous lidocaine. After induction of anesthesia patients will receive 2mg/kg/hr intravenous lidocaine until 1 hour after the operation has ended

    Number of subjects in period 1
    		Overall study
    Started
    55
    Completed
    48
    Not completed
    7
         Consent withdrawn by subject
    1
         change of surgery
    1
         pharmacy was unable to deliver study medication
    2
         Protocol deviation
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 55 55
    Age categorical
    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)
    		 40 40
        From 65-84 years
    		 15 15
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 55 55
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Effect of dexamethasone and lidocaine on cytokine levels
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary outcome measure were the influence of lidocaine and dexamethasone on the difference between plasma levels of cytokines IL-6, IL-10, IL-1β, IL-1Ra, ratio IL-β to IL-1Ra, and the ratio IL-6 to IL-10 at 4 hours postoperative (T2) versus baseline (T0).

    Subject analysis sets values
    		 Effect of dexamethasone and lidocaine on cytokine levels
    Number of subjects
    48
    Age categorical
    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)
    35
        From 65-84 years
    13
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    48
        Male

    End points

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    End points reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 Overall study is pilot 1, 2 and 3 together, all patients recieved lidocaïne or placebo In pilot 1, patients received no dexamethason In pilot 3 patients received dexamethason 4 mg In pilot 3 patients recieved dexamethason 8 mg During all 3 studies the same protocol was followed In total, 55 subjects were enrolled and randomized to receive the study medication (20 subjects in study 1, 17 subjects in study 2, and 18 subjects in study 3). Seven patients were excluded for analysis for the following reasons: the pharmacy was unable to provide study medication for 2 patients (study 1, n = 1; study 3, n =1); the protocol was violated in 3 patients of study 1; the surgical procedure was changed in 1 patient in study 2, and 1 patient withdrew consent in study 3

    Subject analysis set title
    Effect of dexamethasone and lidocaine on cytokine levels
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary outcome measure were the influence of lidocaine and dexamethasone on the difference between plasma levels of cytokines IL-6, IL-10, IL-1β, IL-1Ra, ratio IL-β to IL-1Ra, and the ratio IL-6 to IL-10 at 4 hours postoperative (T2) versus baseline (T0).

    Primary: Influence of lidocaine and dexamethasone on postoperative cytokine levels

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    End point title
    		 Influence of lidocaine and dexamethasone on postoperative cytokine levels [1]
    End point description
    End point type
    Primary
    End point timeframe
    Between baseline and 4 hours postoperative
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: When filling the form, it constantly gives warnings, probably I do something wrong, but cannot find what it is. Multiple linear regression analysis was used to evaluate the null hypothesis that lidocaine or dexamethasone had no effect on ΔIL-6, ΔIL-10, ΔIL-1β, ΔIL-1Ra, ΔIL-6/IL-10 and ΔIL-1β/IL-1Ra. Descriptive analysis preceded formal statistical analysis. Based on a striking pattern in the dataset, we introduced ‘post hoc’ the duration of surgery as an independent variable.
    End point values
    		 Effect of dexamethasone and lidocaine on cytokine levels
    Number of subjects analysed
    48
    Units: pg/mL
        arithmetic mean (standard deviation)
    2.28 ( 1.58 )
    Attachments
    		 Effect on cytokines of lidoc/dex
    raw cytokine levels
    No statistical analyses for this end point

    Secondary: The difference within study groups of pain scores and analgesic use

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    End point title
    		 The difference within study groups of pain scores and analgesic use
    End point description
    End point type
    Secondary
    End point timeframe
    directly after surgery and at 4 hours postoperative
    End point values
    		 Effect of dexamethasone and lidocaine on cytokine levels
    Number of subjects analysed
    48
    Units: numeric rating scale
    48
    Attachments
    		 lidocaine, dexamethason cytokines
    No statistical analyses for this end point

    Secondary: the difference within study groups of the 30-day complication rate

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    End point title
    		 the difference within study groups of the 30-day complication rate
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after surgery
    End point values
    		 Overall study Effect of dexamethasone and lidocaine on cytokine levels
    Number of subjects analysed
    48
    48
    Units: Clavien Dindo Classification
    48
    48
    No statistical analyses for this end point

    Secondary: the correlation of cytokine ratios with pain scores and postoperative complications were evaluated

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    End point title
    		 the correlation of cytokine ratios with pain scores and postoperative complications were evaluated
    End point description
    End point type
    Secondary
    End point timeframe
    baseline (painscore and cytokines), 4 hours after surgery (pain scores and cytokines), and 30days after surgery (complications according to Clavien Dindo Classification)
    End point values
    		 Overall study
    Number of subjects analysed
    48
    Units: cytokine ratios, pain scores and CDC
    48
    Attachments
    		 Correlation pain score and cytokines
    cytokine levels, pain scores, and complications
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse were reported until discharge of the patient from the hospital
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    4
    Reporting groups
    Reporting group title
    nausea
    Reporting group description
    		 postoperative nausea

    Serious adverse events
    		 nausea
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 nausea
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (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: Non-serious adverse event is the same ad adverse events 4 patients had postoperative nausea

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2015
    Amendment for pilot 2: addition of dexamethason 4 mg to all patients
    02 Mar 2016
    Pilot 3: addition of dexamethason 8 mg to all patients

    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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    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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