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    Clinical Trial Results:
    Combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in patients undergoing orthopaedic surgery of the foot and ankle. A randomised, blinded, placebo-controlled, parallel clinical trial.

    Summary
    EudraCT number
    		 2021-000429-28
    Trial protocol
    		 DK  
    Global end of trial date
    17 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2024
    First version publication date
    29 Mar 2024
    Other versions
    Summary report(s)
    		 Exploratory outcome results

    Trial information

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    Trial identification
    Sponsor protocol code
    ADJUNCT-2-2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04818749
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Lykkebækvej 1, Køge, Denmark, 4600
    Public contact
    Department of Anaesthesiology, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark, mmaag@regionsjaelland.dk
    Scientific contact
    Department of Anaesthesiology, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark, mmaag@regionsjaelland.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
    10 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of combined intravenous dexamethasone and dexmedetomidine as adjuncts to popliteal and saphenous nerve blocks in participants undergoing surgery of the ankle or foot.
    Protection of trial subjects
    All participants received routine care apart from the experimental interventions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 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: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    82
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants scheduled for emergency or major ambulatory surgery of the foot or ankle were screened for inclusion. Potential participants were informed of the trial and provided informed consent prior to inclusion in the trial.

    Pre-assignment
    Screening details
    		 Age>18, foot or ankle unilateral surgery, general anesthesia combined with popliteal and saphenous nerve block, ASA 1-3, BMI 18-40, min. weight 50kg, ability to provide informed consent. Exclusion: pregnancy, lack of cooperation, allergy, daily opioid >30mg morphine, daily GCC >5mg prednisone, dysregulated diabetes, alcohol/drug abuse.

    Period 1
    Period 1 title
    Inclusion period (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
    Trial medication was prepared in identically appearing syringes with equal volume by trained staff not otherwise involved in the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants allocated to placebo received 2 infusions of 20mL of saline. First infusion prior to receiving poplitea and saphenous nerve blocks and second infusion after induction of general anaesthesia.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    20 mL of isotonic saline infused prior to block performance and again after induction of general anaesthesia.

    Arm title
    		 Dexamethasone
    Arm description
    		 Participants allocated to the dexamethasone group received 2 infusion. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 20 mL of saline.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    3 ml of 4mg/ml of dexamethasone in 17 mL of saline administered over 12 minutes using an infusion pump.

    Arm title
    		 Dexamethasone with dexmedetomidine
    Arm description
    		 Participants allocated to dexamethasone with dexmedetomidine received 2 infusions. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 1 mcg/kg of dexmedetomidine (actual patient weight) and was administered after induction of general anaesthesia.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    3 ml of 4mg/ml of dexamethasone in 17 mL of saline administered over 12 minutes using an infusion pump.

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    1 mcg/kg of dexmedetomidine in 20 ml of saline, infused over 30 minutes using an infusion pump after induction of general anaesthesia.

    Number of subjects in period 1
    		Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Started
    41
    40
    39
    Completed
    41
    39
    39
    Not completed
    0
    1
    0
         Consent withdrawn by subject
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants allocated to placebo received 2 infusions of 20mL of saline. First infusion prior to receiving poplitea and saphenous nerve blocks and second infusion after induction of general anaesthesia.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Participants allocated to the dexamethasone group received 2 infusion. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 20 mL of saline.

    Reporting group title
    Dexamethasone with dexmedetomidine
    Reporting group description
    		 Participants allocated to dexamethasone with dexmedetomidine received 2 infusions. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 1 mcg/kg of dexmedetomidine (actual patient weight) and was administered after induction of general anaesthesia.

    Reporting group values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine Total
    Number of subjects
    		 41 40 39 120
    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)
    		 56 ( 16 ) 56 ( 17 ) 53 ( 18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 30 24 76
        Male
    		 19 10 15 44
    Diabetes
    Units: Subjects
        Diabetes
    		 0 1 0 1
        No diabetes
    		 41 39 39 119
    Type of surgery
    Units: Subjects
        Fracture
    		 32 23 25 80
        Arthrodesis
    		 9 17 14 40
    Habitual use of analgesics
    Units: Subjects
        Acetaminophen/paracetamol
    		 12 15 19 46
        NSAIDs
    		 6 7 9 22
        Opioids
    		 3 1 2 6
        No use
    		 20 17 9 46
    Weight
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 84 ( 18 ) 79 ( 13 ) 85 ( 17 ) -
    Height
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 173 ( 10 ) 171 ( 10 ) 174 ( 9 ) -
    BMI
    Body Mass Index
    Units: kilogram(s)/cubic metre
        arithmetic mean (standard deviation)
    		 173 ( 10 ) 171 ( 10 ) 174 ( 9 ) -
    Duration of surgery
    Duration of surgery from induction of general anaesthesia until extubation.
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 148 (115 to 175) 158 (113 to 197) 142 (107 to 179) -
    Pre-operative pain level
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    Units: points
        median (inter-quartile range (Q1-Q3))
    		 1 (0 to 2) 3 (1 to 4) 1 (0 to 3.5) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants allocated to placebo received 2 infusions of 20mL of saline. First infusion prior to receiving poplitea and saphenous nerve blocks and second infusion after induction of general anaesthesia.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Participants allocated to the dexamethasone group received 2 infusion. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 20 mL of saline.

    Reporting group title
    Dexamethasone with dexmedetomidine
    Reporting group description
    		 Participants allocated to dexamethasone with dexmedetomidine received 2 infusions. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 1 mcg/kg of dexmedetomidine (actual patient weight) and was administered after induction of general anaesthesia.

    Primary: Duration of analgesia

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    End point title
    		 Duration of analgesia
    End point description
    Participants were instructed to note the time and date of their first sensation of pain (above 0 on the Numerical Rating Scale). The duration of analgesia was defined as the time from block performance until first sensation of pain.
    End point type
    Primary
    End point timeframe
    From block performance until block resolution
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: minute
        median (inter-quartile range (Q1-Q3))
    870 (748 to 1138)
    1400 (1133 to 1750)
    1572 (1259 to 1715)
    Statistical analysis title
    		 Placebo versus dexa
    Statistical analysis description
    Hodges-Lehmann for estimating between group pseudo-median differences and Van Elteren test adjusted for site for p-value.
    Comparison groups
    Dexamethasone v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Van Elteren
    Parameter type
    		 Pseudomedian difference
    Point estimate
    489
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 265
         upper limit
    		 706
    Statistical analysis title
    		 Placebo versus dexa+dexmed
    Statistical analysis description
    Hodges-Lehmann for estimating between group pseudo-median differences and Van Elteren test adjusted for site for p-value.
    Comparison groups
    Placebo v Dexamethasone with dexmedetomidine
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Van Elteren
    Parameter type
    		 Pseudomedian difference
    Point estimate
    564
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 301
         upper limit
    		 794
    Statistical analysis title
    		 Dexa versus dexa + dexmed
    Statistical analysis description
    Hodges-Lehmann for estimating between group pseudo-median differences and Van Elteren test adjusted for site for p-value.
    Comparison groups
    Dexamethasone with dexmedetomidine v Dexamethasone
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 1.67
    Method
    		 Van Elteren
    Parameter type
    		 Pseudomedian difference
    Point estimate
    61
    Confidence interval
         level
    		 98.3%
         sides
    2-sided
         lower limit
    		 -222
         upper limit
    		 331

    Secondary: Duration of motor block

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    End point title
    		 Duration of motor block
    End point description
    End point type
    Secondary
    End point timeframe
    From block performance until first ability to activate calf muscles.
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    36
    39
    35
    Units: minute
        median (inter-quartile range (Q1-Q3))
    1075 (794 to 1306)
    1348 (1177 to 1549)
    1445 (1128 to 1674)
    Statistical analysis title
    		 Placebo vs dexa
    Comparison groups
    Placebo v Dexamethasone
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    289
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60
         upper limit
    		 480
    Statistical analysis title
    		 Placebo vs dexa+dexmed
    Comparison groups
    Placebo v Dexamethasone with dexmedetomidine
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    306
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 85
         upper limit
    		 518
    Statistical analysis title
    		 Dexa vs dexa+dexmed
    Comparison groups
    Dexamethasone v Dexamethasone with dexmedetomidine
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -165
         upper limit
    		 225

    Secondary: Quality of sleep night 1

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    End point title
    		 Quality of sleep night 1
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 worst, 10 best)
    End point type
    Secondary
    End point timeframe
    Postoperative night 1
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    5 (3 to 7.5)
    5 (3.5 to 8)
    No statistical analyses for this end point

    Secondary: Quality of sleep night 2

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    End point title
    		 Quality of sleep night 2
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 worst, 10 best)
    End point type
    Secondary
    End point timeframe
    Second postoperative night
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    6 (6 to 8)
    6 (4 to 8)
    6 (5 to 8)
    No statistical analyses for this end point

    Secondary: Quality of sleep night 3

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    End point title
    		 Quality of sleep night 3
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 worst, 10 best)
    End point type
    Secondary
    End point timeframe
    Third postoperative night
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    8 (6 to 9)
    8 (6 to 9)
    7 (6 to 9)
    No statistical analyses for this end point

    Other pre-specified: Pain at rest 24 hours postoperatively

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    End point title
    		 Pain at rest 24 hours postoperatively
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst perceiveable pain)
    End point type
    Other pre-specified
    End point timeframe
    24 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    3 (0 to 5)
    1 (0 to 4)
    No statistical analyses for this end point

    Other pre-specified: Pain at rest 48 hours postoperatively

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    End point title
    		 Pain at rest 48 hours postoperatively
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    48 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    3 (1 to 4)
    3 (1 to 5)
    2 (1 to 4)
    No statistical analyses for this end point

    Other pre-specified: Pain at rest 72 hours postoperatively

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    End point title
    		 Pain at rest 72 hours postoperatively
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    72 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    1 (0 to 3)
    1.5 (0 to 3.8)
    2 (0 to 3.5)
    No statistical analyses for this end point

    Other pre-specified: Average pain 0-24 hours

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    End point title
    		 Average pain 0-24 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 5)
    2 (0 to 3.5)
    1 (0 to 2)
    No statistical analyses for this end point

    Other pre-specified: Average pain 24-48 hours

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    End point title
    		 Average pain 24-48 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    24-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    4 (2 to 6)
    3 (2 to 5)
    No statistical analyses for this end point

    Other pre-specified: Average pain 48-72 hours

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    End point title
    		 Average pain 48-72 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    48-72 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    2.5 (1 to 4)
    2 (1 to 4)
    No statistical analyses for this end point

    Other pre-specified: Worst pain 0-24 hours

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    End point title
    		 Worst pain 0-24 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    8 (6 to 9)
    5 (0.5 to 6)
    3 (0 to 6)
    No statistical analyses for this end point

    Other pre-specified: Worst pain 24-48 hours

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    End point title
    		 Worst pain 24-48 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    24-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    6 (4 to 7)
    6 (4 to 8)
    6 (4 to 8)
    No statistical analyses for this end point

    Other pre-specified: Worst pain 48-72 hours

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    End point title
    		 Worst pain 48-72 hours
    End point description
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    End point type
    Other pre-specified
    End point timeframe
    48-72 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    5 (2 to 6)
    4 (2 to 7)
    No statistical analyses for this end point

    Other pre-specified: Cumulative opioid consumption 0-24 hours

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    End point title
    		 Cumulative opioid consumption 0-24 hours
    End point description
    Cumulative opioid consumption measured as oral oxycodone equivalents
    End point type
    Other pre-specified
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    20 (10 to 38)
    5 (0 to 10)
    0 (0 to 15)
    No statistical analyses for this end point

    Other pre-specified: Cumulative opioid consumption 0-48 hours

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    End point title
    		 Cumulative opioid consumption 0-48 hours
    End point description
    Cumulative opioid consumption measured in oral oxycodone equivalents
    End point type
    Other pre-specified
    End point timeframe
    0-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    42 (15 to 78)
    30 (15 to 45)
    15 (3 to 53)
    No statistical analyses for this end point

    Other pre-specified: Cumulative opioid consumption 0-72 hours

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    End point title
    		 Cumulative opioid consumption 0-72 hours
    End point description
    Cumulative opioid consumption measured as oral oxycodone equivalents
    End point type
    Other pre-specified
    End point timeframe
    0-72 hours postoperatively
    End point values
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Number of subjects analysed
    41
    39
    39
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    65 (25 to 97)
    38 (15 to 78)
    25 (5 to 78)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected in the intervention period until 72 hours postoperatively
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants allocated to placebo received 2 infusions of 20mL of saline. First infusion prior to receiving poplitea and saphenous nerve blocks and second infusion after induction of general anaesthesia.

    Reporting group title
    Dexamethasone
    Reporting group description
    		 Participants allocated to the dexamethasone group received 2 infusion. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 20 mL of saline.

    Reporting group title
    Dexamethasone with dexmedetomidine
    Reporting group description
    		 Participants allocated to dexamethasone with dexmedetomidine received 2 infusions. The first infusion contained 12 mg of dexamethasone in 20 mL of saline and was administered prior to participants receiving popliteal and saphenous nerve blocks. The second infusion contained 1 mcg/kg of dexmedetomidine (actual patient weight) and was administered after induction of general anaesthesia.

    Serious adverse events
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Infection
    Additional description: Suspected deep tissue infection requiring hospitalisation that was subsequently ruled out
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Ischaemic cerebral infarction
    Additional description: Hospitalised for suspected stroke which was subsequently ruled out.
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 40 (2.50%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Dexamethasone Dexamethasone with dexmedetomidine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 41 (26.83%)
    10 / 40 (25.00%)
    4 / 39 (10.26%)
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    2
    1
    Dizziness
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 40 (5.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    2
    1
    Pyrexia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Chills
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 40 (7.50%)
    0 / 39 (0.00%)
         occurrences all number
    4
    3
    0
    Haemorrhage
    Additional description: Bandage seep through
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    1
    Immune system disorders
    Urticaria
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 40 (7.50%)
    0 / 39 (0.00%)
         occurrences all number
    2
    3
    0
    Vomiting
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    2
    0
    Reflux gastritis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0

    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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