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    Clinical Trial Results:
    Oral dexamethasone as an adjunct to a brachial plexus block in patients undergoing orthopaedic surgery of the forearm and hand. A randomised, blinded, placebo-controlled, parallel, triple-arm clinical trial.

    Summary
    EudraCT number
    		 2021-000428-36
    Trial protocol
    		 DK  
    Global end of trial date
    03 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

    Trial information

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    Trial identification
    Sponsor protocol code
    ADJUNCT-1-2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04853446
    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, Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, mmaag@regionsjaelland.dk
    Scientific contact
    Department of Anaesthesiology, Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, 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
    21 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the beneficial and harmful effects of oral dexamethasone as an adjunct to a lateral infraclavicular block in patients undergoing surgery of the bones of the forearm or hand.
    Protection of trial subjects
    Standard care other than the experimental intervention.
    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: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    104
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adults >=18 years, unilateral surgery of forearm/hand, ASA 1-3, BMI 18-40, min. weight 50kg. Exclusion: pregnancy, inability to provide informed consent, allergy, daily morphine >30mg, daily prednisolone >5mg, alcohol/drug abuse, glaucoma, other surgery needed, other trauma needing opioids.

    Period 1
    Period 1 title
    Inclusion (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 by the pharmacy in identically appearing opaque capsules containing either placebo or 12mg dexamethasone. The trial medication was packaged in identical containers with two capsules in each container, resulting in the possibility of being allocated to placebo, 12mg dexamethasone, or 24mg dexamethasone.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Capsules containing placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Glucosemonohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule, administered 30-60min before block performance.

    Arm title
    		 Dexamethasone 12mg
    Arm description
    		 Capsules containing 12mg dexamethasone.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    12mg dexamethasone administered 30-60min before block performance.

    Arm title
    		 Dexamethasone 24mg
    Arm description
    		 Capsules containing 24mg of dexamethasone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    24mg dexamethasone administered 30-60min before block performance.

    Number of subjects in period 1
    		Placebo Dexamethasone 12mg Dexamethasone 24mg
    Started
    61
    61
    58
    Completed
    61
    59
    55
    Not completed
    0
    2
    3
         Consent withdrawn by subject
    -
    -
    1
         Did not receive nerve block.
    -
    2
    -
         did not receive nerve block
    -
    -
    1
         Dementia
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Capsules containing placebo.

    Reporting group title
    Dexamethasone 12mg
    Reporting group description
    		 Capsules containing 12mg dexamethasone.

    Reporting group title
    Dexamethasone 24mg
    Reporting group description
    		 Capsules containing 24mg of dexamethasone.

    Reporting group values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg Total
    Number of subjects
    		 61 61 58 180
    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)
    		 61.3 ( 14.1 ) 59.4 ( 17.2 ) 62.7 ( 14.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 42 47 136
        Male
    		 14 19 11 44
    Diabetes
    Units: Subjects
        Diabetes
    		 3 3 0 6
        No diabetes
    		 58 58 58 174
    Type of surgery
    Units: Subjects
        Fracture
    		 57 50 51 158
        Non-fracture
    		 4 11 7 22
    Use of analgesics
    Units: Subjects
        Paracetamol
    		 19 23 28 70
        NSAIDs
    		 7 12 14 33
        Anti-depressants
    		 7 8 5 20
        Opioids
    		 4 3 6 13
        No use
    		 24 15 5 44
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 78.6 ( 15.6 ) 78.8 ( 16.5 ) 74.3 ( 14.8 ) -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 171 ( 9.3 ) 172 ( 9.8 ) 170 ( 8.8 ) -
    Body Mass Index
    Units: kilogram(s)/cubic metre
        arithmetic mean (standard deviation)
    		 26.9 ( 4.7 ) 26.7 ( 4.6 ) 25.8 ( 4.5 ) -
    Pre-operative pain
    Measured on the Numerical Rating Scale 0-10 points (0 no pain, 10 worst pain)
    Units: points
        median (inter-quartile range (Q1-Q3))
    		 3 (0 to 4) 3 (1 to 4) 2 (0 to 5) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Capsules containing placebo.

    Reporting group title
    Dexamethasone 12mg
    Reporting group description
    		 Capsules containing 12mg dexamethasone.

    Reporting group title
    Dexamethasone 24mg
    Reporting group description
    		 Capsules containing 24mg of dexamethasone.

    Primary: Duration of analgesia

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    End point title
    		 Duration of analgesia
    End point description
    Participants noted their date and time of their first perception of pain in the surgical area.
    End point type
    Primary
    End point timeframe
    0-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: minute
        arithmetic mean (standard deviation)
    818 ( 292 )
    1171 ( 318 )
    1256 ( 395 )
    Statistical analysis title
    		 Placebo vs 12mg dexamethasone
    Comparison groups
    Placebo v Dexamethasone 12mg
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    354
    Confidence interval
         level
    		 98.33%
         sides
    2-sided
         lower limit
    		 218
         upper limit
    		 490
    Statistical analysis title
    		 Placebo vs 24mg dexamethasone
    Comparison groups
    Placebo v Dexamethasone 24mg
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    437
    Confidence interval
         level
    		 98.33%
         sides
    2-sided
         lower limit
    		 280
         upper limit
    		 594
    Statistical analysis title
    		 12 vs 24mg dexamethasone
    Comparison groups
    Dexamethasone 24mg v Dexamethasone 12mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    85
    Confidence interval
         level
    		 98.33%
         sides
    2-sided
         lower limit
    		 -78
         upper limit
    		 249

    Secondary: Duration of motor block

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    End point title
    		 Duration of motor block
    End point description
    Participants noted their date and time of their first ability to activate their biceps muscle.
    End point type
    Secondary
    End point timeframe
    0-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: minute
        median (inter-quartile range (Q1-Q3))
    813 (660 to 1087)
    1144 (973 to 1335)
    1144 (915 to 1325)
    Statistical analysis title
    		 Placebo vs 12mg dexamethasone
    Comparison groups
    Placebo v Dexamethasone 12mg
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    283
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 148
         upper limit
    		 394
    Statistical analysis title
    		 Placebo vs 24mg dexamethasone
    Comparison groups
    Dexamethasone 24mg v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    232
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 121
         upper limit
    		 356
    Statistical analysis title
    		 12mg vs 24mg dexamethasone
    Comparison groups
    Dexamethasone 24mg v Dexamethasone 12mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63
    Method
    		 VanElteren
    Parameter type
    		 Hodges-Lehmann pseudomedian difference
    Point estimate
    -30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -149
         upper limit
    		 81

    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 sleep, 10 best sleep)
    End point type
    Secondary
    End point timeframe
    First postoperative night
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    5 (4 to 7)
    6 (3.5 to 8)
    6 (3 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 sleep, 10 best sleep)
    End point type
    Secondary
    End point timeframe
    Second postoperative night
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    8 (7 to 9)
    8 (7 to 9)
    8 (7 to 10)
    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 pain)
    End point type
    Other pre-specified
    End point timeframe
    24 hours postoperatively
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 6)
    3 (1 to 4)
    2 (0.5 to 5)
    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 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: Points
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2 (1 to 3)
    2.5 (1 to 4)
    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 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 5)
    2 (0.5 to 4)
    2 (1 to 3)
    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 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    2.5 (1.8 to 4)
    3 (1 to 4)
    3 (2 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 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    7 (5.8 to 8)
    5 (2 to 6.5)
    4 (1.5 to 7)
    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 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 5.3)
    4 (2 to 7)
    5 (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
    Measured in oral oxycodone equivalents
    End point type
    Other pre-specified
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: milligram(s)r
        median (inter-quartile range (Q1-Q3))
    10 (0 to 15)
    0 (0 to 10)
    0 (0 to 10)
    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
    End point type
    Other pre-specified
    End point timeframe
    0-48 hours postoperatively
    End point values
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Number of subjects analysed
    61
    59
    55
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    20 (10 to 30)
    10 (0 to 22.5)
    5 (0 to 22.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-48 hours for adverse events and up until 30 days for serious adverse events.
    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
    		 Capsules containing placebo.

    Reporting group title
    Dexamethasone 12mg
    Reporting group description
    		 Capsules containing 12mg dexamethasone.

    Reporting group title
    Dexamethasone 24mg
    Reporting group description
    		 Capsules containing 24mg of dexamethasone.

    Serious adverse events
    		 Placebo Dexamethasone 12mg Dexamethasone 24mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 61 (1.64%)
    2 / 58 (3.45%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Surgery
    Additional description: Internal fixation failure and re-operation
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 58 (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
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome suspected and ruled out
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture
    Additional description: Fall and fracture of the femoral head.
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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 12mg Dexamethasone 24mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 61 (13.11%)
    5 / 61 (8.20%)
    9 / 58 (15.52%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    2 / 58 (3.45%)
         occurrences all number
    0
    1
    2
    Confusional state
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    General disorders and administration site conditions
    Nauseaea
         subjects affected / exposed
    3 / 61 (4.92%)
    2 / 61 (3.28%)
    1 / 58 (1.72%)
         occurrences all number
    3
    2
    1
    Pyrexia
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Flushing
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Haemorrhage
    Additional description: Bandage seep through
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
         occurrences all number
    3
    1
    0
    Reflux gastritis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1

    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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