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    Clinical Trial Results:
    Interest of parasternal block to prevent hypertensive and tachycardia episodes during sternotomy in patients undergoing coronary artery bypass graft

    Summary
    EudraCT number
    		 2018-002842-35
    Trial protocol
    		 FR  
    Global end of trial date
    07 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2020
    First version publication date
    06 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2018/07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03734159
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CMC Ambroise Paré
    Sponsor organisation address
    27 boulevard Victor Hugo, Neuilly-sur-Seine, France, 92200
    Public contact
    Service Recherche Clinique, CMC Ambroise Paré, +33 146415079, recherche@clinique-a-pare.fr
    Scientific contact
    Service Recherche Clinique, CMC Ambroise Paré, +33 146415079, recherche@clinique-a-pare.fr
    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
    31 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Show that the preoperative realization of a parasternal block reduces the posology of remifentanil administered during sternotomies
    Protection of trial subjects
    This clinical trial was approved by a Committee for Protection of Human Subjects (CPP EST 1-2018/67 N°SI 18.08.28.61039) and the french national agency for medicines and health products safety (ANSM MEDAECNAT-2018-08-00068). The trial was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice. Prior to inclusion, written informed consent was obtained from all subjects after a thorough oral and written participant information had been given.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2018
    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
    France: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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
    24
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included from December 2018 to June 2019. Patients scheduled for coronary artery bypass graft surgery were informed of the study protocol during the preanesthesia visit. They were included never later than the day before the surgery after signing informed consent.

    Pre-assignment
    Screening details
    		 Exclusion criteria : refusal to participate, age <18 years, emergency, contraindications to one or more medications of the protocol, cognitive impairment, major renal failure, chronic pain syndrome, peripheral neuropathy, coexisting hematologic disorders, hypovolemia, corticosteroid or immunosuppressive treatment

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 sodium chloride injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)

    Arm title
    		 Ropivacaine
    Arm description
    		 preoperative parasternal block by ropivacaine injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Injection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)

    Number of subjects in period 1
    		Placebo Ropivacaine
    Started
    17
    18
    Completed
    15
    15
    Not completed
    2
    3
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 sodium chloride injection

    Reporting group title
    Ropivacaine
    Reporting group description
    		 preoperative parasternal block by ropivacaine injection

    Reporting group values
    		 Placebo Ropivacaine Total
    Number of subjects
    		 17 18 35
    Age categorical
    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)
    		 5 5 10
        From 65-84 years
    		 11 13 24
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.5 ± 10.0 69.3 ± 7.8 -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 7
        Male
    		 14 14 28
    Smoking status
    Units: Subjects
        Never
    		 9 6 15
        Former
    		 6 9 15
        Current
    		 2 3 5
    Hypertension
    Units: Subjects
        Yes
    		 15 12 27
        No
    		 2 6 8
    Diabetes
    Units: Subjects
        Yes
    		 7 4 11
        No
    		 10 14 24
    Heart failure
    Units: Subjects
        Yes
    		 2 1 3
        No
    		 15 17 32
    Stroke
    Units: Subjects
        Yes
    		 3 0 3
        No
    		 14 18 32
    Chronic obstructive pulmonary disease
    Units: Subjects
        Yes
    		 2 3 5
        No
    		 15 15 30
    Cancer
    Units: Subjects
        Yes
    		 3 4 7
        No
    		 14 14 28
    Renal failure
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 16 18 34
    Alcohol
    Units: Subjects
        Yes
    		 1 2 3
        No
    		 16 16 32
    BMI
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 26.5 ± 3.3 25.3 ± 3.8 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 sodium chloride injection

    Reporting group title
    Ropivacaine
    Reporting group description
    		 preoperative parasternal block by ropivacaine injection

    Primary: Maximal remifentanil concentration during sternotomy

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    End point title
    		 Maximal remifentanil concentration during sternotomy
    End point description
    Maximal dose of remifentanil (morphine peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during skin incision, sternotomy and sternal retractor setup
    End point type
    Primary
    End point timeframe
    during sternotomy : from skin incision to sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    17
    18
    Units: nanogram(s)/millilitre(s)
        median (inter-quartile range (Q1-Q3))
    7.0 (5.2 to 8.0)
    4.2 (2.5 to 6.0)
    Statistical analysis title
    		 Max remifentanil Ce during sternotomy
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Maximum propofol concentration during sternotomy

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    End point title
    		 Maximum propofol concentration during sternotomy
    End point description
    Maximal dose of propofol (hypnotic peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during skin incision, sternotomy and sternal retractor setup
    End point type
    Secondary
    End point timeframe
    during sternotomy : from skin incision to sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    17
    18
    Units: microgram(s)/millilitre
        arithmetic mean (standard deviation)
    4.97 ± 1.52
    3.88 ± 1.10
    Statistical analysis title
    		 Max propofol Ce during sternotomy
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Dose of hypnotic drug during surgery

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    End point title
    		 Dose of hypnotic drug during surgery
    End point description
    Total amount of propofol administered during surgery
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from induction of anesthesia to skin closure
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    17
    18
    Units: milligram(s)/kilogram/hour
        arithmetic mean (standard deviation)
    6.27 ± 1.46
    5.46 ± 1.21
    Statistical analysis title
    		 Amount of propofol
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Dose of analgesic drug during surgery

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    End point title
    		 Dose of analgesic drug during surgery
    End point description
    Total amount of remifentanil administered during surgery
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from induction of anesthesia to skin closure
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    17
    18
    Units: microgram(s)/kilogram/hour
        arithmetic mean (standard deviation)
    6.43 ± 1.86
    5.25 ± 1.41
    Statistical analysis title
    		 Amount of remifentanil
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Hemodynamic response : heart rate variation

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    End point title
    		 Hemodynamic response : heart rate variation
    End point description
    ΔHR during sternotomy, defined by the difference between the maximal HR reached during sternotomy and the baseline HR0
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    16
    17
    Units: bpm
        median (inter-quartile range (Q1-Q3))
    13.5 (5.7 to 21.5)
    9.0 (5.5 to 15.0)
    Statistical analysis title
    		 Heart rate variation
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Hemodynamic response : systolic arterial blood pressure variation

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    End point title
    		 Hemodynamic response : systolic arterial blood pressure variation
    End point description
    ΔSBP, defined by the difference between the maximal SBP reached during sternotomy and the baseline SBP0
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    16
    17
    Units: mmHg
        arithmetic mean (standard deviation)
    38.4 ± 17.8
    38.7 ± 14.7
    Statistical analysis title
    		 Blood pressure variation
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Hemodynamic response : average patient state index

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    End point title
    		 Hemodynamic response : average patient state index
    End point description
    Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    15
    18
    Units: No unit
        arithmetic mean (standard deviation)
    20.8 ± 7.7
    24.9 ± 8.0
    Statistical analysis title
    		 Average PSI
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Hemodynamic response : minimum patient state index

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    End point title
    		 Hemodynamic response : minimum patient state index
    End point description
    Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)
    End point type
    Secondary
    End point timeframe
    Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    15
    18
    Units: No unit
        arithmetic mean (standard deviation)
    11.7 ± 8.7
    18.3 ± 6.8
    Statistical analysis title
    		 Minimum PSI
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Pain level during extubation

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    End point title
    		 Pain level during extubation
    End point description
    Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)
    End point type
    Secondary
    End point timeframe
    During extubation
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    17
    18
    Units: No unit
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    5 (2 to 6)
    Statistical analysis title
    		 Pain score at extubation
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Inflammatory response

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    End point title
    		 Inflammatory response
    End point description
    Serum concentrations of cytokines : MCP-1, IFN-α2, IFN-γ, IL-1β, IL-6, IL-8, IL-10, IL-12, IL-17A, IL-18, IL-23, IL-33, TNF-α Note : 9999 = N/A (not applicable)
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Placebo Ropivacaine
    Number of subjects analysed
    15
    15
    Units: picogram(s)/millilitre
        arithmetic mean (standard deviation)
    99999 ± 99999
    99999 ± 99999
    Attachments
    		 Inflammatory response
    Statistical analysis title
    		 MCP-1
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-8
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-18
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-6
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.782
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-10
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.777
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-17A
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.184
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-1beta
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.265
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-12p70
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.153
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 TNF-alpha
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.383
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IFN-alpha2
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.222
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-23
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IL-33
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.047
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 IFN-gamma
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.064
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 CRP
    Comparison groups
    Placebo v Ropivacaine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of inclusion to 7 days after surgery
    Adverse event reporting additional description
    All adverse events were evaluated and followed-up by a specialist anesthetist.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ropivacaine
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Ropivacaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Bradycardia
    Additional description: Serious bradycardia (< 35 bpm)
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactoid reaction
    Additional description: Anaphylactoid reaction due to plasmion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         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: 1%
    Non-serious adverse events
    		 Placebo Ropivacaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 17 (82.35%)
    15 / 18 (83.33%)
    Vascular disorders
    Hypertension
    Additional description: Hypertension requiring treatment
         subjects affected / exposed
    10 / 17 (58.82%)
    7 / 18 (38.89%)
         occurrences all number
    17
    10
    Hypotension
    Additional description: Hypotension requiring treatment
         subjects affected / exposed
    7 / 17 (41.18%)
    11 / 18 (61.11%)
         occurrences all number
    14
    20
    Cardiac disorders
    Tachycardia
    Additional description: Tachycardia requiring treatment
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
    Additional description: Bradycardia requiring treatment
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 18 (11.11%)
         occurrences all number
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Diaphragmatic disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 18 (5.56%)
         occurrences all number
    1
    1
    Infections and infestations
    Pneumopathy
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 18 (11.11%)
         occurrences all number
    2
    2

    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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    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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