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    Clinical Trial Results:
    Ropivacain 0,2% plus Dexamethason versus Ropivacain 0,2% plus Placebo in modified pectoral block - A randomized, double-blind, prospective trial

    Summary
    EudraCT number
    		 2018-003001-26
    Trial protocol
    		 AT  
    Global end of trial date
    04 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2023
    First version publication date
    20 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1234
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03700177
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Innsbruck
    Sponsor organisation address
    Anichstraße 35, Innsbruck, Austria, 6020
    Public contact
    Competence Center for Clinical Trials, University Hospital for Anaesthesia and Intensive Care, Anichstrasse 35, 6020 Innsbruck, 0043 512900370086,
    Scientific contact
    Competence Center for Clinical Trials, University Hospital for Anaesthesia and Intensive Care, Anichstrasse 35, 6020 Innsbruck, 0043 512900370086,
    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
    04 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to find out if dexamethason added to modified pectoral block (Pecs II) with ropivacaine 0.2% prolongs analgesic effect
    Protection of trial subjects
    The visual analogue scale (VAS) to assess pain was assessed on admission to the post-anesthesia care unit (PACU), then hourly during the first 12 hours after PECS II block performance, and then every 12 hours until the end of follow-up after 84 hours. If VAS exceeded a value of 30 mm at any time, even without being actively asked by the medical staff, pain medications according to our study protocol were administered. Generally spoken - every patient who needs a mastectomy receives a PECS II block - if not refused by the patient. For this study we didn't change the daily routine, neither in the operating theatre nor on the normal ward.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 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)
    34
    From 65 to 84 years
    22
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Every friday, our operating theatre manager receives the OP schedule for the next week. Therefore, every friday, we checked the OP schedule for mastectomies in the following week and visited the patients on the day of their arrival in the hospital (usually the day before surgery).

    Pre-assignment
    Screening details
    		 Number of patients screened for inclusion were 118. On the day of their arrival in the clinic, they were all checked for eligibility to participate by one of our study members.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Ropivacaine + dexamethasone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Dexabene
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    For the dexamethasone group, 8 mg dexamethasone (2 ml) was added to 28 ml of ropivacaine 0.2%.

    Arm title
    		 Placebo
    Arm description
    		 Ropivacaine + saline solution 0.9%
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline solution 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    For the placebo group, 2 ml of saline solution 0.9% was added to 28 ml of ropivacaine 0.2%.

    Number of subjects in period 1
    		Intervention Placebo
    Started
    30
    30
    Completed
    28
    30
    Not completed
    2
    0
         Did not receive allocated intervention
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Ropivacaine + dexamethasone

    Reporting group title
    Placebo
    Reporting group description
    		 Ropivacaine + saline solution 0.9%

    Reporting group values
    		 Intervention Placebo Total
    Number of subjects
    		 30 30 60
    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)
    		 19 15 34
        From 65-84 years
    		 9 13 22
        85 years and over
    		 2 2 4
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 59.0 (51.3 to 74.8) 69.0 (56.0 to 74.0) -
    Gender categorical
    female patients undergoing unilateral mastectomy who meet inclusion criteria and want to participate
    Units: Subjects
        Female
    		 30 30 60
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Ropivacaine + dexamethasone

    Reporting group title
    Placebo
    Reporting group description
    		 Ropivacaine + saline solution 0.9%

    Primary: Total morphine equivalent consumption in the first 72 hours

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    End point title
    		 Total morphine equivalent consumption in the first 72 hours
    End point description
    End point type
    Primary
    End point timeframe
    72 hours
    End point values
    		 Intervention Placebo
    Number of subjects analysed
    28
    30
    Units: mg
        median (standard deviation)
    11.89 ( 13.03 )
    11.90 ( 10.81 )
    Statistical analysis title
    		 MME - 72 h
    Comparison groups
    Intervention v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.831
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    84h postoperative
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Ropivacaine + dexamethasone

    Reporting group title
    Placebo
    Reporting group description
    		 Ropivacaine + saline solution 0.9%

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 30 (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: 5%
    Non-serious adverse events
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 28 (17.86%)
    10 / 30 (33.33%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    3 / 28 (10.71%)
    7 / 30 (23.33%)
         occurrences all number
    10
    10
    General disorders and administration site conditions
    Shivering
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 30 (0.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    PONV
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 30 (10.00%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2018
    We found out that our patients are being followed-up by the gynecologists every 3 months for approximately 1 year, so we decided that we design a questionnaire to ask for patient satisfaction and pain. By extending the observation period, we had to make a substantial amendment.

    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/34872040
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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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