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    Clinical Trial Results:
    Efficacy of Perioperative Long-acting Anesthesia by Local Infiltration Following Median Sternotomy - The PAIN Trial

    Summary
    EudraCT number
    		 2021-005886-41
    Trial protocol
    		 DK  
    Global end of trial date
    16 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2025
    First version publication date
    15 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AUH-PAIN-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus Universityhospital
    Sponsor organisation address
    Palle Juul-Jensens Blvd 99, Aarhus, Denmark, 8200
    Public contact
    Dept. of Cardiothoracic Surgery, Aarhus University Hospital, 0045 20990948, jonrau@rm.dk
    Scientific contact
    Dept. of Cardiothoracic Surgery, Aarhus University Hospital, 0045 20990948, jonrau@rm.dk
    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
    29 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of long-acting local infiltration anesthesia in patients undergoing coronary bypass grafting through sternotomy.
    Protection of trial subjects
    Intervention was performed under general anesthesia during surgery. A comprehensive follow-up of all participants were performed to ensure the safety of the intervention.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Nov 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 113
    Worldwide total number of subjects
    113
    EEA total number of subjects
    113
    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)
    43
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at two danish univeristy hospitals: Aarhus Univeristyhospital and Aalborg universityhospital from november 2022 until october 2023.

    Pre-assignment
    Screening details
    		 All patients undergoing scheduled coronary artery bypass grafting surgery at the two sites were screened for eligibility to participate.

    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
    		 Investigator, Subject
    Blinding implementation details
    All allocation of either active treatment or placebo were done using REDcap

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active intervention
    Arm description
    		 Participants receiving active treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bupivacaine w adrenaline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    60ml of 2.5mg/ml bubivacaine with 5ug/ml adrenaline

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2ml of 4mg/ml dexamethasone

    Investigational medicinal product name
    Clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    0.5ml og 150ug/ml clonidine

    Arm title
    		 Placebo intervention
    Arm description
    		 Participants recieving placebo intervention
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    62.5ml of 0.9 NaCl

    Number of subjects in period 1
    		Active intervention Placebo intervention
    Started
    57
    56
    Completed
    52
    48
    Not completed
    5
    8
         Protocol deviation
    5
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 113 113
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 43 43
        From 65-84 years
    		 70 70
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 101 101

    End points

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    End points reporting groups
    Reporting group title
    Active intervention
    Reporting group description
    		 Participants receiving active treatment

    Reporting group title
    Placebo intervention
    Reporting group description
    		 Participants recieving placebo intervention

    Primary: OME

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    End point title
    		 OME
    End point description
    Accumulated opioid consumption within the first 24 postoperative hours.
    End point type
    Primary
    End point timeframe
    first 24 postoperative hours
    End point values
    		 Active intervention Placebo intervention
    Number of subjects analysed
    52
    48
    Units: OME
        arithmetic mean (standard deviation)
    68.7 ( 52.3 )
    68.4 ( 38.9 )
    Statistical analysis title
    		 OME
    Comparison groups
    Active intervention v Placebo intervention
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.971
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    the entire study period
    Adverse event reporting additional description
    All participants electronic journals was read thoroughly once the adverese event period was terminated (4 weeks postoperative)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 See above
    Dictionary version
    1
    Reporting groups
    Reporting group title
    entire population
    Reporting group description
    		 -

    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: A threshold of 5% for non-serious adverse events were applied, and there were no non-serious events that was observed with a frequency higher than 5%
    Serious adverse events
    		 entire population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 113 (8.85%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Coronary angio need
    Additional description: participants needing postoperative angio for either suspected ishemia or suspected dysfynctional graft
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Angina
    Additional description: participants with postoperative angina not resulting in coronary angio.
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Late pericardial efusion
    Additional description: No need for intervention
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Prolonged ICU need
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Need for cardial pacemaker
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Fascia defect resulting in need for redo surgery
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    affected kidney function
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 entire population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 113 (0.00%)

    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? Yes
    Date
    Interruption
    Restart date
    19 Dec 2022
    Due to a national delivery stop of clonidine inclusion was paused from 19-dec-2022 until 03-feb-2023
    03 Feb 2023

    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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