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    Clinical Trial Results:
    Fast-track rehabilitation protocol for Total Knee Arthroplasty: A Randomized Controlled Trial comparing Local Infiltration Analgesia with Femoral Nerve Block

    Summary
    EudraCT number
    		 2013-001008-13
    Trial protocol
    		 NL  
    Global end of trial date
    06 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions
    Summary report(s)
    		 Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes

    Trial information

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    Trial identification
    Sponsor protocol code
    497
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01966263
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sint Maartenskliniek
    Sponsor organisation address
    Hengstdal 3, Ubbergen, Netherlands,
    Public contact
    Clinical Trial Information, Sint Maartenskliniek, +31 243659935, m.fenten@maartenskliniek.nl
    Scientific contact
    Clinical Trial Information, Sint Maartenskliniek, +31 243659935, m.fenten@maartenskliniek.nl
    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
    03 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Identifying the optimal anesthesia technique for patients undergoing total knee arthroplasty according to the fast track protocol giving the best functional outcome
    Protection of trial subjects
    escape medication for pain consisted of oxycodon 5 mg per os
    Background therapy
    		 paracetamol 1000 mg q.i.d., etoricoxib 90 mg once daily, and gabapentin 600 mg b.i.d. (300 mg if age >60 yr)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    41
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible participants were all adults aged 50-80 years with ASA physical health classification I, II or III. Patients presented with non-inflammatory knee osteoarthritis and were scheduled for fast track, primary, unilateral total knee arthroplasty under spinal anaesthesia.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Investigator, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 group LIA
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    local infiltration of the anterior capsule with ropivacaine 0.2%, 50 ml plus epinephrine 1:200.000 and of the subcutaneous tissue with ropivacaine 0.2%, 50 ml without epinephrine.

    Arm title
    		 group FNB
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    local infiltration of the anterior capsule with ropivacaine 0.2%, 50 ml plus epinephrine 1:200.000 and of the subcutaneous tissue with ropivacaine 0.2%, 50 ml without epinephrine.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: it was not possible to completely blind the patients, for they are aware whether they receive medication through the perineural catheter or not.
    Number of subjects in period 1
    		group LIA group FNB
    Started
    40
    40
    directly postoperative follow-up
    40
    40
    3 months postoperatively follow up
    40
    38
    Completed
    36
    37
    Not completed
    4
    3
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    1
         Protocol deviation
    3
    1

    Baseline characteristics

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

    Reporting group title
    group FNB
    Reporting group description
    		 -

    Reporting group values
    		 group LIA group FNB Total
    Number of subjects
    		 40 40 80
    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
        arithmetic mean (standard deviation)
    		 66 ( 6.3 ) 64 ( 6.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 20 43
        Male
    		 17 20 37

    End points

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

    Reporting group title
    group FNB
    Reporting group description
    		 -

    Primary: Timed Up and Go Test

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    End point title
    		 Timed Up and Go Test
    End point description
    End point type
    Primary
    End point timeframe
    at 3 months and at 12 months postoperatievly
    End point values
    		 group LIA group FNB
    Number of subjects analysed
    36
    37
    Units: second
        arithmetic mean (standard deviation)
    7.8 ( 1.9 )
    7.6 ( 1.2 )
    Statistical analysis title
    		 timed Up and Go Test
    Comparison groups
    group FNB v group LIA
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 1.1

    Primary: Six Minute Walk Test

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    End point title
    		 Six Minute Walk Test
    End point description
    End point type
    Primary
    End point timeframe
    at 12 months postoperatively
    End point values
    		 group LIA group FNB
    Number of subjects analysed
    36
    36
    Units: meter
        arithmetic mean (standard deviation)
    489 ( 71 )
    505 ( 84 )
    Statistical analysis title
    		 Six Minute Walk Test
    Comparison groups
    group LIA v group FNB
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    -32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -64
         upper limit
    		 -0.4

    Primary: Stair Climb Test

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    End point title
    		 Stair Climb Test
    End point description
    End point type
    Primary
    End point timeframe
    at 12 months
    End point values
    		 group LIA group FNB
    Number of subjects analysed
    36
    37
    Units: second
        arithmetic mean (standard deviation)
    14.3 ( 7.1 )
    13.8 ( 4.7 )
    Statistical analysis title
    		 Stai Climb Test
    Comparison groups
    group LIA v group FNB
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 4.5

    Secondary: Pain score (NRS)

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    End point title
    		 Pain score (NRS)
    End point description
    End point type
    Secondary
    End point timeframe
    at 3 months postoperative
    End point values
    		 group LIA group FNB
    Number of subjects analysed
    36
    37
    Units: dimensionless scale
        arithmetic mean (standard deviation)
    1.5 ( 2.0 )
    1.1 ( 1.8 )
    Statistical analysis title
    		 NRS pain scores
    Comparison groups
    group LIA v group FNB
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from start of anetshesia on the day of surgery untill the last follow up visit at 12 months post operatively
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 toetsingonline
    Dictionary version
    1
    Reporting groups
    Reporting group title
    group LIA
    Reporting group description
    		 -

    Reporting group title
    group FNB
    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: non serious adverse events are not recorded during the study
    Serious adverse events
    		 group LIA group FNB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    falling
    Additional description: One falling incident was recorded. A patient in the FNB group mobilised unattended shortly after her return to the ward. The effects of spinal anaesthesia may not have been fully resolved at this time and may have contributed to the fall.
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 group LIA group FNB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30236246
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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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