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    Clinical Trial Results:
    The ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A double blind, randomised, placebo controlled trial.

    Summary
    EudraCT number
    		 2019-001016-35
    Trial protocol
    		 DK  
    Global end of trial date
    08 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2023
    First version publication date
    19 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZUH-UMPR-MICB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Jens Børglum, Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, +45 30700120, jens.borglum@gmail.com
    Scientific contact
    Jens Børglum, Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, 46323200 30700120, jens.borglum@gmail.com
    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 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We wish to conduct a randomized, placebo controlled and double blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. Our aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer. Our hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10) and opioid related side effects.
    Protection of trial subjects
    The patients were randomized and blinded to the intervention. They were closely followed-up 24 hrs postoperatively at the ward and until 14 days post surgery. The trial included a follow-up 1 year after surgery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    34
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Female patients breast cancer American Society of Anesthesiologists (ASA) physical status II and III ≥18 years Scheduled for unilateral subpectoral implant-based primary breast reconstruction

    Pre-assignment period milestones
    Number of subjects started
    		 35 [1]
    Number of subjects completed
    		 35

    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We aimed at 36 participating patients. During the trial period one patient in the active group was randomized but she was omitted completely from the study because she had a changed indication for surgery shortly before blockade. Thereby, she was randomized but did NOT recieve any intervention.
    Period 1
    Period 1 title
    Trial period (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
    		 Active
    Arm description
    		 Ropivacaine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    50 mg at three thoracic levels (in total 150mg) within the intertransverse tissue complex.

    Arm title
    		 Placebo
    Arm description
    		 Saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline, isotonic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    10 ml isotonic Saline was injected at three thoracic levels (in total 30 ml) within the intertransverse tissue complex

    Number of subjects in period 1 [2]
    		Active Placebo
    Started
    17
    18
    Completed
    17
    18
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We aimed at 36 participating patients. During the trial period one patient in the active group was randomized but she was omitted completely from the study because she had a changed indication for surgery shortly before blockade. Thereby, she was randomized but did NOT recieve any intervention.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 17 18 35
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.2 ( 9 ) 52.3 ( 7.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 18 35
        Male
    		 0 0 0
    Baseline
    Active (n = 17) Mean age (SD), years 50.2 (9) Mean weight (SD), kg 70.2 (15.5) Mean BMI (SD), kg/m2 24.6 (4.2) ASA status (1/2/3), n -/17/- Laterality (left/right), n 4/13 Mean duration of surgery (SD), min 154.8 (38.3) Mean PACU stay (SD), min 97.4 (39.7) Placebo (n = 18) Mean age (SD), years 52.3 (7.6) Mean weight (SD), kg 67.7 (8.8) Mean BMI (SD), kg/m2 24.2 (2.5) ASA status (1/2/3), n -/18/- Laterality (left/right), n 9/9 Mean duration of surgery (SD), min 171.2 (36.7) Mean PACU stay (SD), min 93.5 (32.1)
    Units: Subjects
        Baseline
    		 17 18 35
    Subject analysis sets

    Subject analysis set title
    Ropivacaine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mean age (SD), years Mean weight (SD), kg Mean BMI (SD), kg/m2 ASA status (1/2/3), n Laterality (left/right), n Mean duration of surgery (SD), min Mean PACU stay (SD), min

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mean age (SD), years Mean weight (SD), kg Mean BMI (SD), kg/m2 ASA status (1/2/3), n Laterality (left/right), n Mean duration of surgery (SD), min Mean PACU stay (SD), min

    Subject analysis sets values
    		 Ropivacaine Placebo
    Number of subjects
    17
    18
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.2 ( 9 )
    52.3 ( 7.6 )
    Gender categorical
    Units: Subjects
        Female
    17
    18
        Male
    0
    0
    Baseline
    Active (n = 17) Mean age (SD), years 50.2 (9) Mean weight (SD), kg 70.2 (15.5) Mean BMI (SD), kg/m2 24.6 (4.2) ASA status (1/2/3), n -/17/- Laterality (left/right), n 4/13 Mean duration of surgery (SD), min 154.8 (38.3) Mean PACU stay (SD), min 97.4 (39.7) Placebo (n = 18) Mean age (SD), years 52.3 (7.6) Mean weight (SD), kg 67.7 (8.8) Mean BMI (SD), kg/m2 24.2 (2.5) ASA status (1/2/3), n -/18/- Laterality (left/right), n 9/9 Mean duration of surgery (SD), min 171.2 (36.7) Mean PACU stay (SD), min 93.5 (32.1)
    Units: Subjects
        Baseline
    17
    18

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Subject analysis set title
    Ropivacaine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mean age (SD), years Mean weight (SD), kg Mean BMI (SD), kg/m2 ASA status (1/2/3), n Laterality (left/right), n Mean duration of surgery (SD), min Mean PACU stay (SD), min

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mean age (SD), years Mean weight (SD), kg Mean BMI (SD), kg/m2 ASA status (1/2/3), n Laterality (left/right), n Mean duration of surgery (SD), min Mean PACU stay (SD), min

    Primary: Median oral morphine equivalents

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    End point title
    		 Median oral morphine equivalents
    End point description
    End point type
    Primary
    End point timeframe
    0-24hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17 [1]
    18 [2]
    Units: mg
    median (inter-quartile range (Q1-Q3))
        PP
    75 (45 to 135)
    62.5 (30 to 115)
        ITT
    75 (45 to 135)
    62.5 (30 to 117.5)
    Notes
    [1] - PP 15 ITT 17
    [2] - PP 16 ITT 18
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median oral morphine equivalents

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    End point title
    		 Median oral morphine equivalents
    End point description
    End point type
    Secondary
    End point timeframe
    4 8 12 16 20hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17 [3]
    18
    Units: mg
    median (inter-quartile range (Q1-Q3))
        4hrs
    45 (30 to 80)
    52.5 (0 to 85)
        8hrs
    0 (0 to 15)
    0 (0 to 15)
        12
    0 (0 to 15)
    0 (0 to 15)
        16
    0 (0 to 0)
    0 (0 to 0)
        20
    0 (0 to 15)
    0 (0 to 0)
    Notes
    [3] - PP 16 ITT 18
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median time (IQR) to first opioid

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    End point title
    		 Median time (IQR) to first opioid
    End point description
    End point type
    Secondary
    End point timeframe
    0-24hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: minute
        median (inter-quartile range (Q1-Q3))
    16 (5 to 30)
    10 (4 to 31)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median time (IQR) to first ambulation

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    End point title
    		 Median time (IQR) to first ambulation
    End point description
    End point type
    Secondary
    End point timeframe
    When admitted
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: minute
        median (inter-quartile range (Q1-Q3))
    330 (240 to 480)
    375 (240 to 480)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median time (IQR) to discharge

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    End point title
    		 Median time (IQR) to discharge
    End point description
    End point type
    Secondary
    End point timeframe
    30-248
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: hours
        median (full range (min-max))
    97 (70 to 117)
    90.5 (68 to 120)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Opioid related side effects: nausea and vomiting

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    End point title
    		 Opioid related side effects: nausea and vomiting
    End point description
    End point type
    Secondary
    End point timeframe
    0-24hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: Number
    6
    5
    Statistical analysis title
    		 CHI Squared
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: QOR Mean baseline score

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    End point title
    		 QOR Mean baseline score
    End point description
    End point type
    Secondary
    End point timeframe
    0hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: number
        arithmetic mean (confidence interval 95%)
    133.9 (130.1 to 137.7)
    133.9 (130.1 to 137.7)
    Statistical analysis title
    		 constrained linear mixed model
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: QOR Mean 24 hours follow-up score

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    End point title
    		 QOR Mean 24 hours follow-up score
    End point description
    End point type
    Secondary
    End point timeframe
    24hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: Number
        arithmetic mean (confidence interval 95%)
    105.2 (80 to 130.3)
    119.59 (106.8 to 132.1)
    Statistical analysis title
    		 constrained linear mixed model
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: QOR Mean 14 days follow-up score

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    End point title
    		 QOR Mean 14 days follow-up score
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: Number
        arithmetic mean (confidence interval 95%)
    125.5 (104 to 147)
    132.5 (121.5 to 143.5)
    Statistical analysis title
    		 constrained linear mixed model
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Median max NRS scores

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    End point title
    		 Median max NRS scores
    End point description
    End point type
    Secondary
    End point timeframe
    0-24hrs
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: number
    median (inter-quartile range (Q1-Q3))
        PACU
    1 (1 to 3)
    3 (1 to 5)
        15
    3 (2 to 4)
    3 (2 to 4)
        30
    3 (2 to 4)
    3 (2 to 3)
        45
    3 (1 to 4)
    2.5 (2 to 4)
        1h
    2 (1 to 3)
    2 (2 to 3)
        1-4
    2 (1 to 2)
    1 (1 to 2)
        4-8
    2 (1 to 2)
    1 (1 to 2)
        8-12
    1 (0 to 2)
    1 (0 to 1)
        12-16
    1 (0 to 2)
    1 (0 to 1)
        16-20
    1 (1 to 2)
    1 (0 to 1)
        20-24
    1 (0 to 2)
    1 (0 to 1)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Median NRS scores (IQR) at block application

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    End point title
    		 Median NRS scores (IQR) at block application
    End point description
    End point type
    Secondary
    End point timeframe
    momentary
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    18
    Units: number
    median (inter-quartile range (Q1-Q3))
        t2
    2 (1 to 5)
    5.5 (4 to 7)
        t4
    2 (1 to 3)
    5.5 (3 to 7)
        t6
    3 (1 to 3)
    3 (2 to 5)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-24hrs
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (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
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 17 (35.29%)
    5 / 18 (27.78%)
    Gastrointestinal disorders
    Nausea/Vomiting
         subjects affected / exposed
    6 / 17 (35.29%)
    5 / 18 (27.78%)
         occurrences all number
    6
    5

    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
    For support, Contact us.
    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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