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    Clinical Trial Results:
    Open heart surgery – does it have to hurt that much? PACS – Parasternal After Cardiac Surgery. A prospective randomised study to assess the analgesic effect of a continuous bilateral parasternal block with lidocaine after sternotomy.

    Summary
    EudraCT number
    		 2018-004672-35
    Trial protocol
    		 SE  
    Global end of trial date
    16 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2025
    First version publication date
    26 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PACS2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet
    Sponsor organisation address
    Nobels väg 6, Solna, Sweden,
    Public contact
    Mark Larsson, Karolinska University Hospital, Dep of Cardiothoracic Anesthesia and Intensive Care, 46 851770914, mark.larsson@sll.se
    Scientific contact
    Mark Larsson, Karolinska Institutet, Department of Molecular Medicine and Surgery, 46 851770914, mark.larsson@ki.se
    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
    16 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study will test the hypothesis that a continuous bilateral parasternal block with lidocaine will decrease postoperative pain after sternotomy for open cardiac surgery.
    Protection of trial subjects
    The trial was approved by the Swedish Ethical Review Authority (registration number 2019e05120) and the Swedish Medical Products Agency (registration number 5.1-2019-78659).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    17
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men and non-pregnant women scheduled for elective open heart surgery through a sternotomy at the Karolinska University Hospital were considered for enrolment.

    Pre-assignment
    Screening details
    		 Ineligibility: emergency or redo surgery, severe left heart failure, respiratory insufficiency, advanced kidney failure, pronounced hepatic disease, allergy to local anaesthetics, psychiatric disease or any psychoactive medication, cognitive disturbance, or inability to understand instructions, and a history of chronic pain or chronic pain medic.

    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, Carer, Assessor, Subject
    Blinding implementation details
    Treatment was randomized in a 1:1 fashion in blocks of eight, except for the last block of five. The trial participants, investigators, attending surgeons, anaesthesiologist, and nurse anaesthetist, and the nurses in the recovery room and surgical ward, were blinded to allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lidocaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    After wound closure at the end of surgery, a multi-hole 19-cm silver-coated catheter (ON-Q Soaker; Avanos Medical, Alpharetta, GA, USA) was inserted on either side of the sternum, under the pectoral muscle and over the costosternal margin. A 20-ml bolus of lidocaine 5 mg/ml was administered through each catheter. Thereafter, an elastomeric pump that contained the allocated treatment provided an infusion of 7 ml/h to each catheter.

    Arm title
    		 Saline
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    After wound closure at the end of surgery, a multi-hole 19-cm silver-coated catheter (ON-Q Soaker; Avanos Medical, Alpharetta, GA, USA) was inserted on either side of the sternum, under the pectoral muscle and over the costosternal margin. A 20-ml bolus of saline 9 mg/ml (0.9%) was administered through each catheter. Thereafter, an elastomeric pump that contained the allocated treatment provided an infusion of 7 ml/h to each catheter.

    Number of subjects in period 1
    		Lidocaine Saline
    Started
    23
    22
    Completed
    13
    17
    Not completed
    10
    5
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    3
    -
         Lost to follow-up
    4
    4

    Baseline characteristics

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

    Reporting group title
    Saline
    Reporting group description
    		 -

    Reporting group values
    		 Lidocaine Saline Total
    Number of subjects
    		 23 22 45
    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
        median (inter-quartile range (Q1-Q3))
    		 71 (56 to 74) 67.5 (58 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 5
        Male
    		 21 19 40
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 75.9 ( 10.3 ) 84.5 ( 18.5 ) -
    Height
    Units: centimetre
        median (inter-quartile range (Q1-Q3))
    		 178 (170 to 182) 174.5 (169 to 180) -

    End points

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    End points reporting groups
    Reporting group title
    Lidocaine
    Reporting group description
    		 -

    Reporting group title
    Saline
    Reporting group description
    		 -

    Primary: Cumulative administration of i.v. PCA morphine at 72 hours

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    End point title
    		 Cumulative administration of i.v. PCA morphine at 72 hours
    End point description
    End point type
    Primary
    End point timeframe
    Measured at 72h
    End point values
    		 Lidocaine Saline
    Number of subjects analysed
    23
    22
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    10 (5 to 19)
    28.2 (16 to 42.5)
    Statistical analysis title
    		 Difference in cumulative morphine in mg
    Comparison groups
    Saline v Lidocaine
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total morphine dose after surgery

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    End point title
    		 Total morphine dose after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Post surgery
    End point values
    		 Lidocaine Saline
    Number of subjects analysed
    23
    22
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    17 (7 to 23)
    38.2 (21 to 60.5)
    Statistical analysis title
    		 Difference in total morphine in mg
    Comparison groups
    Lidocaine v Saline
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start of the intervention until end of follow-up at 3 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Serious adverse events
    		 Overall study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 45 (35.56%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Permanent Pacemaker
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Redo bleeding
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ulcus ventriculi/duodeni
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sternal wound infection
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 45 (31.11%)
    Gastrointestinal disorders
    Postoperative nausea and vomiting
         subjects affected / exposed
    9 / 45 (20.00%)
         occurrences all number
    9
    Psychiatric disorders
    Not alert
         subjects affected / exposed
    14 / 45 (31.11%)
         occurrences all number
    14

    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/38680128
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