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    Clinical Trial Results:
    The effect of Phrenic nerve blokade on acute and chronic shoulder pain in patients for lobectomy and pneumonectomy.

    Summary
    EudraCT number
    		 2012-002844-25
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2021
    First version publication date
    26 Jul 2021
    Other versions
    Summary report(s)
    		 Summary of results

    Trial information

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    Trial identification
    Sponsor protocol code
    12.006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J.B.Winsloews Vej 4, Odense, Denmark, 5000
    Public contact
    Morten Rune Blichfeldt-Eckhardt, Morten Rune Blichfeldt-Eckhardt, +45 65412528, morten.rune.blichfeldt-eckhardt@ouh.regionsyddanmark.dk
    Scientific contact
    Morten Rune Blichfeldt-Eckhardt, Morten Rune Blichfeldt-Eckhardt, +45 65412528, morten.rune.blichfeldt-eckhardt@ouh.regionsyddanmark.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
    08 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether blockade of the phrenic nerve can reduce postoperative shoulder pain after lobectomy and pneumonectomy.
    Protection of trial subjects
    Patients were given the optimal treatment before, under and after the procedures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 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
    Denmark: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    27
    From 65 to 84 years
    48
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: November 2012 - June 2014. Recruitment place: Odense University Hospital, Denmark

    Pre-assignment
    Screening details
    		 screening criteria: scheduled for elective lobectomy or pneumonectomy for non-small cell lung cancer, aged > 18 y, appropriate Danish language skills to complete the pre-operative questionnaire.

    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, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 intervention
    Arm description
    		 Participants receive phrenic nerve block with Ropivacaine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    Ropivacaine 10mg/ml

    Arm title
    		 Placebo
    Arm description
    		 Recieved a phrenic nerve block with Saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Saline 0.9%

    Number of subjects in period 1
    		intervention Placebo
    Started
    38
    38
    Completed
    38
    38

    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
    		 76 76
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 27 27
        From 65-84 years
    		 48 48
        85 years and over
    		 1 1
        Adults
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 Participants receive phrenic nerve block with Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Recieved a phrenic nerve block with Saline

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in the study, analysed for the primary end point

    Primary: Ipsilateral shoulder pain within 6 hours after surgery.

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    End point title
    		 Ipsilateral shoulder pain within 6 hours after surgery.
    End point description
    End point type
    Primary
    End point timeframe
    6 hours after surgery
    End point values
    		 intervention Placebo Primary endpoint
    Number of subjects analysed
    38
    38
    76
    Units: number of participants
        Participants with shoulder pain
    9
    26
    35
        Participants without shoulder pain
    29
    12
    41
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    intervention v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.00001
    Method
    		 Chi-squared
    Parameter type
    		 Relatie risk reduction
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During hospitalization, first week after dismission and at the 1 year follow up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 38 (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: 1%
    Non-serious adverse events
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 38 (15.79%)
    0 / 38 (0.00%)
    Musculoskeletal and connective tissue disorders
    Motor block of arm
    Additional description: Motorical blockade of the ipsilateral arm
         subjects affected / exposed
    6 / 38 (15.79%)
    0 / 38 (0.00%)
         occurrences all number
    15
    0

    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
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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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