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    Clinical Trial Results:
    The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.

    Summary
    EudraCT number
    		 2013-002764-12
    Trial protocol
    		 FR  
    Global end of trial date
    07 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 May 2021
    First version publication date
    07 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I12019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01670448
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital, Limoges
    Sponsor organisation address
    02 avenue martin Luther King, Limoges, France, 87042
    Public contact
    coordinator investigator, University Hospital, Limoges, +33 555056300, jeromemcros@yahoo.fr
    Scientific contact
    coordinator investigator, University Hospital, Limoges, +33 555056300, jeromemcros@yahoo.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 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Estimate the analgesic efficiency of the pectoral block
    Protection of trial subjects
    Patients are informed and an information note is issued. A consent is signed. Patients are followed up to 7 days after the pectoral block
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Canada: 49
    Country: Number of subjects enrolled
    France: 79
    Worldwide total number of subjects
    128
    EEA total number of subjects
    79
    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)
    96
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The pre-inclusion visit is provided by the doctor. The pre-inclusion visit takes place at the time of the anesthesia consultation. the doctor informs the patient about the study and answers all her questions. The patient has a period of reflection until the day of the surgery. The day before of surgery (inclusion visit), consent is obtained.

    Pre-assignment
    Screening details
    		 patients are screened during staff meetings

    Period 1
    Period 1 title
    inclusion
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    The pharmacy will make sealed, masked lots, with patient numbers according to the randomization list. These lots will be sent to the care unit no later than the morning of inclusion. A nurse not involved in patient care will prepare the product for the open study (physiological saline or bupivacaine), the product will then be sent to the doctor with patient labeling without the possibility of identifying the group.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Bupivacaine
    Arm description
    		 PECBLOCK performed with bupivacaine
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    N01BB01
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All patients will have ultrasound guided pectoral block. Under general anesthesia and under sterile conditions, after ultrasound identification of the interpectoral space (between the pectoralis major and pectoralis minor muscles), a 22G and 50 mm needle will be inserted for the administration of 0.4 mL / kg of bupivacaine 0, 25% adrenaline (1/200,000) without exceeding 40 mL or de 0,4 mL/kg de NaCl 0,9%. Patients weighing more than 100 kg will receive 40 mL of 0.25% bupivacaine adrenaline or 0.9% NaCl.

    Arm title
    		 Placebo
    Arm description
    		 PECBLOCK performed with NaCl 0.9%
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All patients will have ultrasound guided pectoral block. Under general anesthesia and under sterile conditions, after ultrasound identification of the interpectoral space, a 22G and 50 mm needle will be inserted for the administration of 0.4 mL / kg of 0.9% NaCl.

    Number of subjects in period 1
    		Bupivacaine Placebo
    Started
    62
    65
    Completed
    62
    65
    Period 2
    Period 2 title
    recovery room
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Bupivacaine
    Arm description
    		 Active drug given through PECBLOCK in these patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    bupivacaïne 0,25% adrénalinée

    Arm title
    		 Placebo
    Arm description
    		 Placebo drug given through PECBLOCK in these patients
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    NaCl 0.9%

    Number of subjects in period 2
    		Bupivacaine Placebo
    Started
    62
    65
    Completed
    62
    65
    Period 3
    Period 3 title
    first 24 hours post surgery
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bupivacaine
    Arm description
    		 Active drug given through PECBLOCK in these patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Active drug given through PECBLOCK in these patients.

    Arm title
    		 Placebo
    Arm description
    		 Placebo drug given through PECBLOCK in these patients
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    NaCl 0.9%

    Number of subjects in period 3
    		Bupivacaine Placebo
    Started
    62
    65
    Completed
    62
    65

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    inclusion
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: a patient has withdrawn her consent
    Reporting group values
    		 inclusion Total
    Number of subjects
    		 127 127
    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)
    		 95 95
        From 65-84 years
    		 32 32
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60.5 (51 to 68) -
    Gender categorical
    FEMALE
    Units: Subjects
        Female
    		 127 127
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    analgesic efficacy of the pectoral block
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    pain was assessed by a verbal simple numerical scale (ENS) 30 minutes after admission to the recovery room or just before morphine titration

    Subject analysis set title
    Assessment and comparison of pain scores at rest and on postop
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Assessment and comparison of pain scores at rest and on postoperative mobilization

    Subject analysis set title
    Comparison of Sufentanil Consumption During Surgery
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Comparison of Sufentanil Consumption During Surgery

    Subject analysis set title
    Comparison of morphine dose to recovery room
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Comparison of morphine dose to recovery room

    Subject analysis sets values
    		 analgesic efficacy of the pectoral block Assessment and comparison of pain scores at rest and on postop Comparison of Sufentanil Consumption During Surgery Comparison of morphine dose to recovery room
    Number of subjects
    127
    127
    127
    127
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    95
    95
    95
    95
        From 65-84 years
    31
    32
    32
    32
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    60.5 (51 to 68)
    60.5 (51 to 68)
    60.5 (51 to 68)
    60.5 (51 to 68)
    Gender categorical
    FEMALE
    Units: Subjects
        Female
    127
    127
    127
    127
        Male

    End points

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    End points reporting groups
    Reporting group title
    Bupivacaine
    Reporting group description
    		 PECBLOCK performed with bupivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 PECBLOCK performed with NaCl 0.9%
    Reporting group title
    Bupivacaine
    Reporting group description
    		 Active drug given through PECBLOCK in these patients.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo drug given through PECBLOCK in these patients
    Reporting group title
    Bupivacaine
    Reporting group description
    		 Active drug given through PECBLOCK in these patients.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo drug given through PECBLOCK in these patients

    Subject analysis set title
    analgesic efficacy of the pectoral block
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    pain was assessed by a verbal simple numerical scale (ENS) 30 minutes after admission to the recovery room or just before morphine titration

    Subject analysis set title
    Assessment and comparison of pain scores at rest and on postop
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Assessment and comparison of pain scores at rest and on postoperative mobilization

    Subject analysis set title
    Comparison of Sufentanil Consumption During Surgery
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Comparison of Sufentanil Consumption During Surgery

    Subject analysis set title
    Comparison of morphine dose to recovery room
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Comparison of morphine dose to recovery room

    Primary: Pain score at rest in the recovery room

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    End point title
    		 Pain score at rest in the recovery room
    End point description
    Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
    End point type
    Primary
    End point timeframe
    30 min after entering the recovery room
    End point values
    		 Bupivacaine Placebo Bupivacaine Placebo Bupivacaine Placebo Assessment and comparison of pain scores at rest and on postop
    Number of subjects analysed
    62
    65
    62
    65
    62
    65
    127
    Units: 0-10 verbal numerical scale
    62
    65
    62
    65
    62
    65
    127
    Statistical analysis title
    		 end point 1
    Comparison groups
    Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Assessment and comparison of pain scores at rest and on postop
    Number of subjects included in analysis
    508
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 4
    Variability estimate
    Standard deviation
    Dispersion value
    0

    Secondary: Total morphine consumption in the recovery room

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    End point title
    		 Total morphine consumption in the recovery room
    End point description
    When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded
    End point type
    Secondary
    End point timeframe
    in the recovery room before discharge (after 1 h on average)
    End point values
    		 Bupivacaine Placebo Bupivacaine Placebo Bupivacaine Placebo Comparison of morphine dose to recovery room
    Number of subjects analysed
    62
    65
    62
    65
    62
    65
    127
    Units: mg
        number (not applicable)
    62
    65
    62
    65
    62
    65
    127
    Statistical analysis title
    		 end point 2
    Comparison groups
    Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Comparison of morphine dose to recovery room
    Number of subjects included in analysis
    508
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 6
    Variability estimate
    Standard deviation
    Dispersion value
    0

    Secondary: Total sufentanil consumption during surgery

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    End point title
    		 Total sufentanil consumption during surgery
    End point description
    When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.
    End point type
    Secondary
    End point timeframe
    at the end of surgery (1-2 h on average)
    End point values
    		 Bupivacaine Placebo Bupivacaine Placebo Bupivacaine Placebo Comparison of Sufentanil Consumption During Surgery
    Number of subjects analysed
    62
    65
    62
    65
    62
    65
    127
    Units: microcurie(s)/microgram
        number (not applicable)
    62
    65
    62
    65
    62
    65
    127
    Statistical analysis title
    		 end point 3
    Comparison groups
    Bupivacaine v Placebo v Bupivacaine v Placebo v Bupivacaine v Placebo v Comparison of Sufentanil Consumption During Surgery
    Number of subjects included in analysis
    508
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (net)
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15
         upper limit
    		 23
    Variability estimate
    Standard deviation
    Dispersion value
    0

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    post intervention
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Pacebo
    Reporting group description
    		 -

    Reporting group title
    bupivacaïne
    Reporting group description
    		 -

    Serious adverse events
    		 Pacebo bupivacaïne
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (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: 4%
    Non-serious adverse events
    		 Pacebo bupivacaïne
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2013
    Modification of the non-inclusion criteria: - Patient already operated on the ipsilateral breast in order not to recruit a patient who has already undergone an operation on the same breast - Bilateral surgery: addition of this non-inclusion criteria in order not to bias the scores on pain

    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/29672368
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