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    Clinical Trial Results:
    The effect of saphenous nerve and obturator nerve block combined with systemic high dose glucocorticoid versus local infiltration analgesia combined with a systemic high dose glucocorticoid on opioid consumption and pain after total knee arthroplasty.

    Summary
    EudraCT number
    		 2014-003343-35
    Trial protocol
    		 DK  
    Global end of trial date
    16 Nov 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CR-TFB-2014/502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus, Denmark, 8200
    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
    20 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2015
    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 block with a mixture of local analgesics; ropivacaine and adrenaline, compared with combined local infiltration analgesia in the tissue around the knee joint both methods combined with systemic high dose glucocorticoid on opioid consumption after total knee arthroplasty.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and approved by the Danish Medicines Agency, the Central Denmark Region Committees on Health Research Ethics, and the Danish Danish Protection Agency. The trial was prospectively registered in the EudraCT data base and was monitored by the Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals. Prior to inclusion, written informed consent was obtained from all subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2015
    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
    Denmark: 82
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    12
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 INCLUSION:> 50 years, ASA I–III, scheduled for cemented, unilateral, primary TKA, and spinal anesthesia. EXCLUSION: Inability to cooperate, non-Danish speakers, immunosuppressive therapy, diabetes, lower-limb neuropathy, daily glucocorticoids/opioids, allergy to drugs used in the study, alcohol or drug abuse, and intolerance to NSAID.

    Period 1
    Period 1 title
    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
    		 Combined active ONB+FTB group
    Arm description
    		 Combined active ONB+FTB group: Active ONB + active FTB + active intravenous ketorolac (1 mL 30 mg) + sham LIA. All patients received intravenous dexamethasone 16 mg prior to the spinal anesthesia ONB = obturator nerve block; FTB = femoral triangle block; LIA = local infiltration analgesia
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine 0.75% w. epinephrine 5 micrograms/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Ropivacaine 10 mL for each active ONB and FTB.

    Investigational medicinal product name
    Sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    Isotonic saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    150 mL for sham LIA.

    Investigational medicinal product name
    Ketorolac 3%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg (1 mL) intravenously.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received intravenous dexamethasone 16 mg

    Arm title
    		 Active LIA
    Arm description
    		 Active LIA: Active LIA + sham ONB + sham FTB + sham intravenous ketorolac (1 mL saline). All patients received intravenous dexamethasone 16 mg prior to spinal anesthesia.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    Isotonic saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL for each sham ONB and FTB.

    Investigational medicinal product name
    Ropivacaine 0.2% w. epinephrine 5 micrograms/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    150 mL for active LIA.

    Investigational medicinal product name
    Ketorolac 3%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    45 mg for active LIA

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received intravenous dexamethasone 16 mg

    Number of subjects in period 1
    		Combined active ONB+FTB group Active LIA
    Started
    41
    41
    Completed
    35
    39
    Not completed
    6
    2
         Failed spinal anesthesia
    -
    1
         Adverse event, non-fatal
    1
    -
         Preoperative opioid use
    1
    1
         Competitive hip pain
    1
    -
         Not able to cooperate
    1
    -
         Perioperative angina
    1
    -
         NSAID intolerance
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Combined active ONB+FTB group
    Reporting group description
    		 Combined active ONB+FTB group: Active ONB + active FTB + active intravenous ketorolac (1 mL 30 mg) + sham LIA. All patients received intravenous dexamethasone 16 mg prior to the spinal anesthesia ONB = obturator nerve block; FTB = femoral triangle block; LIA = local infiltration analgesia

    Reporting group title
    Active LIA
    Reporting group description
    		 Active LIA: Active LIA + sham ONB + sham FTB + sham intravenous ketorolac (1 mL saline). All patients received intravenous dexamethasone 16 mg prior to spinal anesthesia.

    Reporting group values
    		 Combined active ONB+FTB group Active LIA Total
    Number of subjects
    		 41 41 82
    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)
    		 69 ( 6.5 ) 68 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 19 43
        Male
    		 17 22 39
    BMI
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 28.8 ( 4.5 ) 29.1 ( 4.5 ) -
    Duration of surgery
    Units: minute
        arithmetic mean (standard deviation)
    		 66 ( 14 ) 69 ( 15 ) -

    End points

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    End points reporting groups
    Reporting group title
    Combined active ONB+FTB group
    Reporting group description
    		 Combined active ONB+FTB group: Active ONB + active FTB + active intravenous ketorolac (1 mL 30 mg) + sham LIA. All patients received intravenous dexamethasone 16 mg prior to the spinal anesthesia ONB = obturator nerve block; FTB = femoral triangle block; LIA = local infiltration analgesia

    Reporting group title
    Active LIA
    Reporting group description
    		 Active LIA: Active LIA + sham ONB + sham FTB + sham intravenous ketorolac (1 mL saline). All patients received intravenous dexamethasone 16 mg prior to spinal anesthesia.

    Primary: Opioid consumption

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    End point title
    		 Opioid consumption
    End point description
    The primary outcome was cumulated consumption of intravenous morphine equivalents during the first 20 hours after surgery, which was selected to ensure that all nerve blocks would remain fully effective during the entire time interval
    End point type
    Primary
    End point timeframe
    20 hours after surgery
    End point values
    		 Combined active ONB+FTB group Active LIA
    Number of subjects analysed
    35 [1]
    39 [2]
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    6 (2 to 18)
    20 (12 to 28)
    Notes
    [1] - 6 patients were excluded before data was collected ana analyzed
    [2] - 2 patients were excluded before data was collected ana analyzed
    Statistical analysis title
    		 Opioid consumption
    Statistical analysis description
    Continuous variables with skewed distribution are presented as median (inter- quartile range [IQR]. For nonparametric data, Mann-Whitney U test was used.
    Comparison groups
    Active LIA v Combined active ONB+FTB group
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From block/LIA procedure and until surgery
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Combined active ONB+FTB group
    Reporting group description
    		 Combined active ONB+FTB group: Active ONB + active FTB + active intravenous ketorolac (1 mL 30 mg) + sham LIA. ONB = obturator nerve block; FTB = femoral triangle block; LIA = local infiltration analgesia

    Reporting group title
    Active LIA
    Reporting group description
    		 Active LIA: Active LIA + sham ONB + sham FTB + sham intravenous ketorolac (1 mL saline)

    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: 2 serious adverse events were reported. No non-serious adverse events were reported from block/LIA procedure and until surgery. After surgery dizziness was reported: Group active ONB + FTB: 2 patients after 6 hrs; 5 patients after 20 hrs; 9 patients after 24 hrs. Group active LIA: 5 patients after 6 hrs; 18 patients after 20 hrs; 18 patients after 24 hrs.
    Serious adverse events
    		 Combined active ONB+FTB group Active LIA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Vasovagal event
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Combined active ONB+FTB group Active LIA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (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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