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    Clinical Trial Results:
    Impact of the serratus plane block in pain and in the use of opioids in breast surgery

    Summary
    EudraCT number
    		 2015-005773-21
    Trial protocol
    		 ES  
    Global end of trial date
    06 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2022
    First version publication date
    10 Feb 2022
    Other versions
    Summary report(s)
    		 Article IBMS-SPB

    Trial information

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    Trial identification
    Sponsor protocol code
    IBMS-SPB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Sanitaria La Fe de Valencia
    Sponsor organisation address
    Avenida Fernando Abril Martorell, Torre 106 A 7planta, Valencia, Spain, 46026
    Public contact
    UREC, INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    Scientific contact
    UREC, INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    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
    22 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the use of opioid drugs during breast oncologic surgery and to analyze the efficacy of serratus plane block as a opiates-saving method.
    Protection of trial subjects
    The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions. An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2016
    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
    Spain: 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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients undergoing oncologic and/or reconstructive breast surgery whose pathology and surgical intervention requires a hospital stay of at least 24 hours.

    Pre-assignment
    Screening details
    		 >18 years old, ASA classification (I-III), patients undergoing breast oncological surgery and/or breast reconstructive whose surgical proceadure needs a postoperative income of, at least, 24 hours.

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 60

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 With no block of serratum muscle
    Arm type
    		 Active comparator

    Investigational medicinal product name
    No Blocking of Serratum Muscle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    No Blocking of Serratum Muscle

    Arm title
    		 Experimental Group
    Arm description
    		 With block of the Serratum muscle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Blockage of Serrartum muscle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Analgesic block of the serratus muscle is performed by means of a high-frequency flat probe ultrasound.

    Number of subjects in period 1
    		Control group Experimental Group
    Started
    30
    30
    Completed
    30
    28
    Not completed
    0
    2
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Analysis
    Reporting group description
    		 -

    Reporting group values
    		 Analysis Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 60 60
    Gender categorical
    Units: Subjects
        Female
    		 60 60
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 With no block of serratum muscle

    Reporting group title
    Experimental Group
    Reporting group description
    		 With block of the Serratum muscle

    Primary: Opioid consumption

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    End point title
    		 Opioid consumption
    End point description
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 Control group Experimental Group
    Number of subjects analysed
    30
    28
    Units: mg
        median (confidence interval 95%)
    30 (21 to 41)
    18.5 (14.5 to 29)
    Statistical analysis title
    		 T-Test
    Comparison groups
    Control group v Experimental Group
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 14.5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All events that meet the definition of an AE and occur within the period from when the patient signs the informed consent form and until the end of the post-treatment follow-up period required by the protocol should be recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    		 No adverse events have been recorded in the final Report

    Serious adverse events
    		 Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 60 (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: No serious Adverse Events have been recorded in the Final Result Report

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30640653
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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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