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    Clinical Trial Results:
    The effect of the popliteal plexus block on postoperative opioid consumption, pain, muscle strength and mobilization after total knee arthroplasty - a randomized, controlled, blinded study

    Summary
    EudraCT number
    		 2021-000242-17
    Trial protocol
    		 DK  
    Global end of trial date
    26 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2024
    First version publication date
    29 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Protocol_PPB_TKA_14012021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus Universitet (Aarhus)
    Sponsor organisation address
    Falkevej 1A, Silkeborg, Denmark, 8600
    Public contact
    Johan Kløvgaard Sørensen, Silkeborg Regional Hospital, Elective Surgery Centre, 0045 28945356, joksoe@rm.dk
    Scientific contact
    Johan Kløvgaard Sørensen, Silkeborg Regional Hospital, Elective Surgery Centre, 0045 28945356, joksoe@rm.dk
    Sponsor organisation name
    Aarhus Universitet (Aarhus)
    Sponsor organisation address
    Falkevej 1A, Silkeborg, Denmark, 8600
    Public contact
    Charlotte Runge, Silkeborg Regional Hospital, Elective Surgery Centre, 0045 25883172, charlotte.runge@aarhus.rm.dk
    Scientific contact
    Charlotte Runge, Silkeborg Regional Hospital, Elective Surgery Centre, 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
    26 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aim to evaluate the analgesic effects of three different nerve block regimens (Popliteal Plexus Block + Femoral Triangle Block versus Femoral Triangle Block versus Adductor Canal Block) after primary unilateral total knee arthroplasty (TKA), in order to optimize pain treatment for TKA patients and minimize the use of opioids. We observe TKA patients opioid consumption and pain scores in the period of 24 hours postoperative, while testing their muscle strength and ability to mobilize.
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2021
    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: 165
    Worldwide total number of subjects
    165
    EEA total number of subjects
    165
    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)
    34
    From 65 to 84 years
    127
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 165
    Number of subjects completed
    		 165

    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
    Blinding implementation details
    Three experienced regional anesthesiologists and their assistants who were responsible for performing the nerve and sham blocks, were not blinded to the treatment and excluded from further patient treatment, data collection, and data handling. All patients, outcome assessors, data analysts, and other personnel involved in the patient's treatment were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Popliteal plexus block
    Arm description
    		 10 mL for Popliteal Plexus Block including 15 mL for Femoral Triangle block
    Arm type
    		 Experimental

    Investigational medicinal product name
    Marcaine 0.5%
    Investigational medicinal product code
    09930
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL for Popliteal Plexus Block 15 mL for Femoral Triangle Block

    Arm title
    		 Femoral Triangle Block
    Arm description
    		 15 mL for Femoral Triangle Block
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Marcaine 0.5%
    Investigational medicinal product code
    09930
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    15 mL for Femoral Triangle Block

    Arm title
    		 Adductor Canal Block
    Arm description
    		 25 mL for Adductor Canal Block
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Marcaine 0.5%
    Investigational medicinal product code
    09930
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    25 mL for Adductor Canal Block

    Number of subjects in period 1
    		Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Started
    55
    55
    55
    Completed
    53
    53
    55
    Not completed
    2
    2
    0
         Consent withdrawn by subject
    -
    1
    -
         Converted to general anesthesia peroperative
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Popliteal plexus block
    Reporting group description
    		 10 mL for Popliteal Plexus Block including 15 mL for Femoral Triangle block

    Reporting group title
    Femoral Triangle Block
    Reporting group description
    		 15 mL for Femoral Triangle Block

    Reporting group title
    Adductor Canal Block
    Reporting group description
    		 25 mL for Adductor Canal Block

    Reporting group values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block Total
    Number of subjects
    		 55 55 55 165
    Age categorical
    Units: Subjects
        Above 50 years of age
    		 55 55 55 165
    Age continuous
    Units: years
        median (full range (min-max))
    		 71 (52 to 85) 72 (54 to 86) 74 (53 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 24 30 27 81
        Male
    		 31 25 28 84

    End points

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    End points reporting groups
    Reporting group title
    Popliteal plexus block
    Reporting group description
    		 10 mL for Popliteal Plexus Block including 15 mL for Femoral Triangle block

    Reporting group title
    Femoral Triangle Block
    Reporting group description
    		 15 mL for Femoral Triangle Block

    Reporting group title
    Adductor Canal Block
    Reporting group description
    		 25 mL for Adductor Canal Block

    Primary: 24-hour total intravenous oxycodone consumption

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    End point title
    		 24-hour total intravenous oxycodone consumption
    End point description
    End point type
    Primary
    End point timeframe
    From end of surgery time until 24 after surgery
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: mg
        median (inter-quartile range (Q1-Q3))
    6 (2 to 12)
    10 (8 to 16)
    12 (6 to 18)
    Statistical analysis title
    		 PPB+FTB vs. FTB
    Statistical analysis description
    Pairwise comparison
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 -1
    Notes
    [1] - Difference in mg Oxycodone intravenous
    Statistical analysis title
    		 PPB+FTB vs. ACB
    Statistical analysis description
    Pairwise comparison
    Comparison groups
    Popliteal plexus block v Adductor Canal Block
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 -1.3
    Notes
    [2] - Difference in mg Oxycodone intravenous
    Statistical analysis title
    		 FTB vs. ACB
    Statistical analysis description
    Pairwise comparison
    Comparison groups
    Popliteal plexus block v Adductor Canal Block v Femoral Triangle Block
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.99
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 3.1
    Notes
    [3] - Difference in mg Oxycodone intravenous
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.01
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: 12- hours postoperative oxycodone consymption

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    End point title
    		 12- hours postoperative oxycodone consymption
    End point description
    End point type
    Secondary
    End point timeframe
    From end-of-surgery time to 12 hours after surgery
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: mg
        median (inter-quartile range (Q1-Q3))
    2 (0 to 6)
    6 (2 to 8)
    6 (2 to 8)
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Adductor Canal Block v Femoral Triangle Block v Popliteal plexus block
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.01
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: MVIC plantar flexion

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    End point title
    		 MVIC plantar flexion
    End point description
    Postblock maximum voluntary isometric contraction (MVIC), expressed as percentage of preblock value of plantar flexion of the ankle.
    End point type
    Secondary
    End point timeframe
    MVIC was tested before nerve block was performed and re-tested 60 minutes after nerve block. This was conducted on the day of surgery, in the preparation room before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: Percentage
        arithmetic mean (standard deviation)
    107 ( 13 )
    105 ( 14 )
    103 ( 16 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2
    Method
    		 ANOVA
    Confidence interval

    Secondary: MVIC dorsi flexion

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    End point title
    		 MVIC dorsi flexion
    End point description
    Postblock maximum voluntary isometric contraction (MVIC), expressed as percentage of preblock value of plantar flexion of the ankle.
    End point type
    Secondary
    End point timeframe
    MVIC was tested before nerve block was performed and re-tested 60 minutes after nerve block. This was conducted on the day of surgery, in the preparation room before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: Percentage
        arithmetic mean (standard deviation)
    106 ( 15 )
    101 ( 15 )
    103 ( 15 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.42
    Method
    		 ANOVA
    Confidence interval

    Secondary: MVIC knee extension

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    End point title
    		 MVIC knee extension
    End point description
    Postblock maximum voluntary isometric contraction (MVIC), expressed as percentage of preblock value of plantar flexion of the ankle.
    End point type
    Secondary
    End point timeframe
    MVIC was tested before nerve block was performed and re-tested 60 minutes after nerve block. This was conducted on the day of surgery, in the preparation room before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: Percentage
        arithmetic mean (standard deviation)
    90 ( 26 )
    93 ( 25 )
    94 ( 28 )
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.66
    Method
    		 ANOVA
    Confidence interval

    Secondary: Timed up and go test

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    End point title
    		 Timed up and go test
    End point description
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    43
    41
    43
    Units: second
        median (inter-quartile range (Q1-Q3))
    30 (22 to 48)
    31 (26 to 35)
    32 (22 to 46)
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.61
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Worst pain during Timed up and go test

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    End point title
    		 Worst pain during Timed up and go test
    End point description
    Pain was rated on a numeric rating scale, with 0 = no pain and 10 = worst imaginable pain
    End point type
    Secondary
    End point timeframe
    Timed up and go test was performed 5 hours after end-of-surgery time
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    43
    41
    43
    Units: Numeric rate 0-10
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    3 (3 to 4)
    4 (3 to 5)
    No statistical analyses for this end point

    Secondary: Postblock MMT plantar flexion ankle

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    End point title
    		 Postblock MMT plantar flexion ankle
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 60 minutes after nerve block, before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: level
    number (not applicable)
        normal muscle activity and joint motion
    55
    55
    55
        Joint motion only able by elimination of gravity o
    0
    0
    0
        muscle activity detectable but no joint motion
    0
    0
    0
        no muscle activity or joint motion detectable
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Postblock MMT dorsi flexion ankle

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    End point title
    		 Postblock MMT dorsi flexion ankle
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 60 minutes after nerve block, before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: Level
    number (not applicable)
        normal muscle activity and joint motion
    55
    55
    55
        Joint motion only able by elimination of gravity
    0
    0
    0
        muscle activity detectable but no joint motion
    0
    0
    0
        no muscle activity or joint motion detectable
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Postblock MMT knee extension

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    End point title
    		 Postblock MMT knee extension
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 60 minutes after nerve block, before surgery.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    55
    55
    55
    Units: level
    number (not applicable)
        normal muscle activity and joint motion
    54
    55
    54
        Joint motion only able by elimination of gravity
    0
    0
    0
        muscle activity detectable but no joint motion
    0
    0
    1
        no muscle activity or joint motion detectable
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Postoperative MMT plantar flexion ankle

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    End point title
    		 Postoperative MMT plantar flexion ankle
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 5 hours after end-of-surgery time
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: level
    number (not applicable)
        normal muscle activity and joint motion
    53
    52
    54
        Joint motion only able by elimination of gravity
    0
    0
    1
        muscle activity detectable but no joint motion
    0
    0
    0
        no muscle activity or joint motion detectable
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Postoperative MMT dorsi flexion ankle

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    End point title
    		 Postoperative MMT dorsi flexion ankle
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 5 hours after end-of-surgery time
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: level
    number (not applicable)
        normal muscle activity and joint motion
    53
    52
    54
        Joint motion only able by elimination of gravity
    0
    0
    1
        muscle activity detectable but no joint motion
    0
    0
    0
        no muscle activity or joint motion detectable
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Postoperative MMT knee extension

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    End point title
    		 Postoperative MMT knee extension
    End point description
    MMT = Manual muscle test: 3 = normal muscle activity and joint motion 2 = Joint motion only able by elimination of gravity or minimal help from an investigator 1 = muscle activity detectable but no joint motion detectable 0 = no muscle activity or joint motion detectable
    End point type
    Secondary
    End point timeframe
    Obtained 5 hours after end-of-surgery time
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: level
    number (not applicable)
        normal muscle activity and joint motion
    50
    50
    54
        Joint motion only able by elimination of gravity
    1
    2
    0
        muscle activity detectable but no joint motion
    1
    0
    1
        no muscle activity or joint motion detectable
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Postoperative Pain at rest

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    End point title
    		 Postoperative Pain at rest
    End point description
    Numeric rating scale 0 = no pain 10 = worst imaginable pain
    End point type
    Secondary
    End point timeframe
    Pain scores were obtained at enrollment on the day of surgery (before block), 2, 5, 7, 20 and 24 hours after end-of-surgery time.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: Numeric rating from 0 - 10
    53
    53
    55
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Neither did we find any interactions between time and group at pain at rest (p=0.18)
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.25 [4]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [4] - No difference between groups in pain at rest

    Secondary: Postoperative pain during active knee flexion

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    End point title
    		 Postoperative pain during active knee flexion
    End point description
    Active knee flexion up till maximum of 90 degree flexion of the knee. Numeric rating scale 0 = no pain 10 = worst imaginable pain
    End point type
    Secondary
    End point timeframe
    Pain scores were obtained at enrollment on the day of surgery (before block), 2, 5, 7, 20 and 24 hours after end-of-surgery time.
    End point values
    		 Popliteal plexus block Femoral Triangle Block Adductor Canal Block
    Number of subjects analysed
    53
    53
    55
    Units: Numeric rating from 0-10
    53
    53
    55
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Neither did we find any interactions between time and group at pain during active flexion (p=0.06)
    Comparison groups
    Popliteal plexus block v Femoral Triangle Block v Adductor Canal Block
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.98
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    9 April 2021 - 26 June 2023
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 description
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Popliteal Plexus Block + Femoral Triangle Block
    Reporting group description
    		 Patients allocated to a Popliteal plexus block as adjuct to a Femoral Triangle Block

    Reporting group title
    Femoral Triangle Block
    Reporting group description
    		 Patients allocated to standalone femoral triangle block

    Reporting group title
    Adductor canal block
    Reporting group description
    		 Patients allocated to standalone adductor canal block

    Serious adverse events
    		 Popliteal Plexus Block + Femoral Triangle Block Femoral Triangle Block Adductor canal block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Postoperative impeded quadriceps muscle strength
    Additional description: Causing prolonged hospitalization, as the affected patients were discharged the on postoperative day 2 instead of postoperative day 1.
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative nausea and vomitting
    Additional description: Causing prolonged hospitalization, as the affected patients were discharged the on postoperative day 2 instead of postoperative day 1.
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative bleeding from the incision line
    Additional description: Causing prolonged hospitalization, as the affected patients were discharged the on postoperative day 2 instead of postoperative day 1.
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.7%
    Non-serious adverse events
    		 Popliteal Plexus Block + Femoral Triangle Block Femoral Triangle Block Adductor canal block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 55 (9.09%)
    4 / 55 (7.27%)
    9 / 55 (16.36%)
    General disorders and administration site conditions
    Postoperative presyncope/syncope
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 55 (5.45%)
    7 / 55 (12.73%)
         occurrences all number
    12
    12
    12
    Musculoskeletal and connective tissue disorders
    Quadriceps weakness after TKA
    Additional description: Normally seen after total knee arthroplasty (TKA), but is also seen after anesthesia of the femoral nerve (femoral triangle block or adductor canal block)
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 55 (1.82%)
    2 / 55 (3.64%)
         occurrences all number
    6
    6
    6

    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/39019501
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