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    Clinical Trial Results:
    Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty. Randomized clinical trial.

    Summary
    EudraCT number
    		 2019-005010-19
    Trial protocol
    		 ES  
    Global end of trial date
    30 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2022
    First version publication date
    07 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HCB/2019/1148
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04681547
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospital CLÍNIC
    Sponsor organisation address
    Villaroel 170, Barcelona, Spain, 08036
    Public contact
    Anestesiología y Reanimación, Hospital Clínic de Barcelona, 34 932275558, cunat@clinic.cat
    Scientific contact
    Anestesiología y Reanimación, Hospital Clínic de Barcelona, 645152055 932275558, cunat@clinic.cat
    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
    30 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to verify that the ultrasound-guided blockade of the genicular nerves is not inferior in terms of analgesic efficacy in comparison with the LIA in the first 24 hours of the postoperative period of primary TKA and during the first mobilization using the NRS score.
    Protection of trial subjects
    As the experimental technique was performed as part of the standard care protocol, no additional measures were taken.
    Background therapy
    		 Standard care for TKA
    Evidence for comparator
    		 Ultrasound-guided genicular nerves blockade (GNB) is a technique that has been effectively used for a variety of chronic knee pain conditions and as an analgesic technique in the surgical and acute pain settings selectively targeting sensory branches from the knee capsule.
    Actual start date of recruitment
    15 Dec 2020
    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
    Spain: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    10
    From 65 to 84 years
    49
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 83 subjects were screened and 60 were enrolled and randomized. One subject in the GNB group was discontinued due to difficulties adhering to study protocol amidst the Covid-19 pandemic. Ultimately, 29 patients in the GNB group and 30 patients in the LIA group were included for analysis.

    Pre-assignment
    Screening details
    		 A total of 83 subjects were examined. Finally, 15 refused to participate. Five subjects were excluded because of obesity, 2 because of preference for general anesthesia, and 1 because of excessive baseline opioid use.

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Monitor, Data analyst [2]
    Blinding implementation details
    Post anaesthesia care unit (PACU) and ward nurses, as well a physical therapists and research assistants, were blinded for treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Local infiltration analgesia
    Arm description
    		 Local infiltration analgesia
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Solution for injection
    Dosage and administration details
    The LIA was performed at the end of the surgical procedure and was based on the administration of ropivacaine 0.2% 150 ml (100 ml of ropivacaine 0.2% with 1 mg of adrenaline during the ischemia period and subsequently, before closure of the surgical wound, 50 ml of ropivacaine 0.2%).

    Investigational medicinal product name
    Adrenaline
    Investigational medicinal product code
    C01CA24
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Solution for injection
    Dosage and administration details
    Administration of ropivacaine 0.2% 150 ml (100 ml of ropivacaine 0.2% with 1 mg of adrenaline during the period of intraoperative ischemia and, before closure of the surgical wound, 50 ml of ropivacaine 0.2%).

    Arm title
    		 Genicular nerves block
    Arm description
    		 Genicular nerves block
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Solution for injection
    Dosage and administration details
    GNB (geniculate nerve block): 4 ml of ropivacaine 0.2%, with adrenaline 1:100 000 was administered in each of the 5 nerves to be blocked (20 ml in total).

    Investigational medicinal product name
    Adrenaline
    Investigational medicinal product code
    C01CA24
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Solution for injection
    Dosage and administration details
    Four ml of ropivacaine 0.2%, with adrenaline 1:100 000 were administered in each of the 5 nerves to be blocked (20 ml in total).

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Post anaesthesia care unit (PACU) and ward nurses, as well a physical therapists and research assistants, were blinded for treatment allocation.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Post anaesthesia care unit (PACU) and ward nurses, as well a physical therapists and research assistants, were blinded for treatment allocation.
    Number of subjects in period 1
    		Local infiltration analgesia Genicular nerves block
    Started
    30
    30
    Completed
    30
    29
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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

    Reporting group values
    		 Recruitment Total
    Number of subjects
    		 60 60
    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)
    		 10 10
        From 65-84 years
    		 49 49
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73 ± 6.62 -
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 16 16
    ASA
    Units: Subjects
        ASA I
    		 5 5
        ASA II
    		 41 41
        ASA III
    		 14 14
    Body Mass Index
    Units: BMI
        arithmetic mean (standard deviation)
    		 29.8 ± 4.18 -
    Womac total score
    Units: Womac
        median (inter-quartile range (Q1-Q3))
    		 -
    BPI inference
    Units: BPI
        median (inter-quartile range (Q1-Q3))
    		 -
    BPI intensity
    Units: BPI
        median (inter-quartile range (Q1-Q3))
    		 -
    Subject analysis sets

    Subject analysis set title
    Overall analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Age, gendre, ASA physical status, BMI, WOMAC score and BPI inference and intensity scores were recorded.

    Subject analysis sets values
    		 Overall analysis
    Number of subjects
    59
    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)
    10
        From 65-84 years
    49
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    72.3 ± 6.66
    Gender categorical
    Units: Subjects
        Female
    44
        Male
    16
    ASA
    Units: Subjects
        ASA I
    5
        ASA II
    40
        ASA III
    14
    Body Mass Index
    Units: BMI
        arithmetic mean (standard deviation)
    29.8 ± 4.18
    Womac total score
    Units: Womac
        median (inter-quartile range (Q1-Q3))
    92.5 (72.5 to 109)
    BPI inference
    Units: BPI
        median (inter-quartile range (Q1-Q3))
    4.7 (3.7 to 6)
    BPI intensity
    Units: BPI
        median (inter-quartile range (Q1-Q3))
    3.25 (2.5 to 5)

    End points

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    End points reporting groups
    Reporting group title
    Local infiltration analgesia
    Reporting group description
    		 Local infiltration analgesia

    Reporting group title
    Genicular nerves block
    Reporting group description
    		 Genicular nerves block

    Subject analysis set title
    Overall analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Age, gendre, ASA physical status, BMI, WOMAC score and BPI inference and intensity scores were recorded.

    Primary: 24 h rest NRS

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    End point title
    		 24 h rest NRS
    End point description
    24 h NRS at rest
    End point type
    Primary
    End point timeframe
    24 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: NRS
        median (inter-quartile range (Q1-Q3))
    3 (2.25 to 5)
    2 (1 to 3)
    Statistical analysis title
    		 24 h NRS at rest
    Comparison groups
    Genicular nerves block v Local infiltration analgesia
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PACU NRS

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    End point title
    		 PACU NRS
    End point description
    End point type
    Secondary
    End point timeframe
    PACU
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: NRS
        median (inter-quartile range (Q1-Q3))
    2 (1 to 4)
    2 (0 to 4)
    Statistical analysis title
    		 PACU NRS
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: 12 h NRS

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    End point title
    		 12 h NRS
    End point description
    End point type
    Secondary
    End point timeframe
    12 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: NRS
        median (inter-quartile range (Q1-Q3))
    4 (2 to 5)
    3 (1 to 5)
    Statistical analysis title
    		 12 h NRS
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: 24 physiotherapy NRS

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    End point title
    		 24 physiotherapy NRS
    End point description
    End point type
    Secondary
    End point timeframe
    24 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: NRS
        median (inter-quartile range (Q1-Q3))
    3 (2 to 6)
    3 (2 to 4)
    Statistical analysis title
    		 24 h physiotherapy NRS
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cumulative OME 24 h consumption

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    End point title
    		 Cumulative OME 24 h consumption
    End point description
    End point type
    Secondary
    End point timeframe
    24 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: mg
        median (inter-quartile range (Q1-Q3))
    5 (0 to 10)
    10 (5 to 12)
    Statistical analysis title
    		 Cumulative OME 24 h consumption
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Minimum articular range

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    End point title
    		 Minimum articular range
    End point description
    End point type
    Secondary
    End point timeframe
    24 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: degrees
        median (inter-quartile range (Q1-Q3))
    -2.5 (-5 to 5)
    -5 (-5 to 5)
    Statistical analysis title
    		 Minimum articular range
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Maximum articular balance

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    End point title
    		 Maximum articular balance
    End point description
    End point type
    Secondary
    End point timeframe
    24 h
    End point values
    		 Local infiltration analgesia Genicular nerves block
    Number of subjects analysed
    30
    29
    Units: degrees
        median (inter-quartile range (Q1-Q3))
    85 (81.3 to 89.5)
    85 (80 to 90)
    Statistical analysis title
    		 Maximum articular range
    Comparison groups
    Local infiltration analgesia v Genicular nerves block
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Intra and postoperative period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Local infiltration analgesia
    Reporting group description
    		 -

    Reporting group title
    Genicular nerves block
    Reporting group description
    		 -

    Serious adverse events
    		 Local infiltration analgesia Genicular nerves block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (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: 0%
    Non-serious adverse events
    		 Local infiltration analgesia Genicular nerves block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    Surgical and medical procedures
    Bleeding
    Additional description: One patient presented minor postoperative surgical wound bleeding that required transfusion and was treated conservatively.
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2021
    The sample size was modified from 54 to 60 patients (27 to 30 patients per arm). This change was motivated by the need to use unilateral contrast tests in the calculation of the sample size (and therefore with an alpha error of 0.025) when the primary objective is noninferiority and taking into account a dropout of 10%.

    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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