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    Clinical Trial Results:
    The effect of protracted saphenous nerve and obturator nerve blockade versus saphenous nerve blockade versus local infiltration analgesia in opioid consumption, pain, blockade duration of action and mobilization after total knee arthroplasty.

    Summary
    EudraCT number
    		 2013-005010-36
    Trial protocol
    		 DK  
    Global end of trial date
    29 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2021
    First version publication date
    23 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR-TFB-2013/502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02067078
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Nørrebrogade 44, Aarhus, Denmark, 8000
    Public contact
    Centre of elective surgery, Hospital of Silkeborg, 0045 25883172, charlotte.runge@aarhus.rm.dk
    Scientific contact
    Centre of elective surgery, Hospital of Silkeborg, 0045 25883172, charlotte.runge@aarhus.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 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim is to investigate the effect of combined saphenous nerve and obturator nerve blockade with a mixture of local analgesics; bupivacain, adrenalin, clonidine and dexamethasone (protacted mixture), compared with saphenous nerve blockade with protracted mixture, compared with local infiltration analgesia in the tissue around the knee joint on opioid consumption after total knee arthroplasty.
    Protection of trial subjects
    The subjects are registered by an trial number
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2014
    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: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    25
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Sceduled for primary total knee alloplasty in spinal anesthesia

    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, Monitor, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Saphenous and obturator nerve group
    Arm description
    		 Received active bupivacaine+ epinephrine+dexamethasone in the blockades
    Arm type
    		 Active comparator

    Investigational medicinal product name
    bupivacaine + epinephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    50 mg

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2 mg

    Arm title
    		 Saphenous block
    Arm description
    		 Received saphneous blockade
    Arm type
    		 Active comparator

    Investigational medicinal product name
    bupivacaine + epinephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    50 mg

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    2 mg

    Arm title
    		 Local infiltration analgesia
    Arm description
    		 Received intraoperative local infiltration analgesia
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Saphenous and obturator nerve group Saphenous block Local infiltration analgesia
    Started
    25
    25
    25
    Completed
    25
    25
    25

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Saphenous and obturator nerve group
    Reporting group description
    		 Received active bupivacaine+ epinephrine+dexamethasone in the blockades

    Reporting group title
    Saphenous block
    Reporting group description
    		 Received saphneous blockade

    Reporting group title
    Local infiltration analgesia
    Reporting group description
    		 Received intraoperative local infiltration analgesia

    Primary: total opioid consumption during first 24 hours

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    End point title
    		 total opioid consumption during first 24 hours
    End point description
    End point type
    Primary
    End point timeframe
    end of surgery to 24 hours after surgery
    End point values
    		 Saphenous and obturator nerve group Saphenous block Local infiltration analgesia
    Number of subjects analysed
    25
    25
    25
    Units: milligram(s)/24 hours
        arithmetic mean (inter-quartile range (Q1-Q3))
    2 (0 to 15)
    20 (10 to 26)
    17 (10 to 36)
    Statistical analysis title
    		 nonparametric data
    Statistical analysis description
    The three groups were compared with Kruskal-Wallis test. If the P value was inferior to 0.05 the groups were compared 1:1 using the Mann-Whitney U test
    Comparison groups
    Saphenous and obturator nerve group v Saphenous block v Local infiltration analgesia
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    0-14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    studygroup
    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: All serious adverse events have been reported. No non-serious adverse events have registered.
    Serious adverse events
    		 studygroup
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 75 (9.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Cardiac disorders
    Sudden death
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Embolic pneumonia
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    hemorrhage
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    exacerbation in COLD
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 studygroup
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 75 (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? 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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