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    Clinical Trial Results:
    The anxiolytic effects of melatonin: A randomized, placebo-controlled, double-blinded clinical study.

    Summary
    EudraCT number
    		 2014-003789-25
    Trial protocol
    		 DK  
    Global end of trial date
    13 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2021
    First version publication date
    01 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    mela1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02386319
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of surgery, Herlev Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    Dennis Bregner Zetner, Department of surgery, Herlev Hospital, 0045 27291376, dennis.bregner.zetner@regionh.dk
    Scientific contact
    Dennis Bregner Zetner, Department of surgery, Herlev Hospital, 45 27291376, dennis.bregner.zetner@regionh.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 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study's main objective is to investigate melatonins anxiolytic effects in surgical patients (inguinal or umbilical hernia).
    Protection of trial subjects
    Besides the study intervention, trial participants received standard care including a common anesthetic and analgesic regimen.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2020
    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: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    27
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 56 patients were screened for inclusion. 6 of these patients did not meet the inclusion criteria. 20 patients were excluded due to unwlllingness to participate.

    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
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Melatonin
    Arm description
    		 The group of patients receiving melatonin treatment related to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Melatonin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4x10 mg melatonin. First dose of 10 mg 21:00 the night before surgery, second dose of 10 mg, 2 hours before surgery, third dose of 10 mg after surgery and final dose of 10 mg 21:00 the day of surgery

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Oral tablet placebo x 4. 1st tablet. 21:00 the night before surgery 2nd tablet. 2 hours before surgery 3rd tablet. After surgery 4th tablet. 21:00 the day of surgery.

    Number of subjects in period 1
    		Melatonin Placebo
    Started
    18
    18
    Completed
    16
    17
    Not completed
    2
    1
         Consent withdrawn by subject
    -
    1
         surgery cancelled
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 The group of patients receiving melatonin treatment related to surgery

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Melatonin Placebo Total
    Number of subjects
    		 18 18 36
    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
        median (inter-quartile range (Q1-Q3))
    		 57 (45 to 62) 60 (50 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 18 18 36
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 87 (73 to 95) 90 (81 to 94) -
    Height
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 184 (180 to 190) 181 (176 to 187) -
    State anxiety
    STAI scale, state anxiety at enrolment
    Units: STAI
        median (inter-quartile range (Q1-Q3))
    		 27 (22 to 34) 27 (23 to 31) -
    Trait anxiety
    Baseline trait anxiety on the STAI scale
    Units: STAI
        median (inter-quartile range (Q1-Q3))
    		 30 (23 to 34) 27 (24 to 30) -
    VAS anxiety
    Visual Analogue Scale of anxiety at the time of enrolment
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    		 5 (0 to 10) 5 (1 to 14) -

    End points

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    End points reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 The group of patients receiving melatonin treatment related to surgery

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Preoperative anxiety (STAI), one hour before surgery

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    End point title
    		 Preoperative anxiety (STAI), one hour before surgery
    End point description
    End point type
    Primary
    End point timeframe
    Anxiety measured one hour before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: STAI
        median (inter-quartile range (Q1-Q3))
    27 (24 to 34)
    28 (24 to 33)
    Statistical analysis title
    		 Preoperative STAI
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.814
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: VAS anxiety one hour before surgery

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    End point title
    		 VAS anxiety one hour before surgery
    End point description
    Anxiety measured by Visual Analogue Scale, from 0 = no anxiety to 100= highest possible anxiety
    End point type
    Secondary
    End point timeframe
    VAS anxiety one hour before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    7 (0 to 28)
    7 (1 to 13)
    Statistical analysis title
    		 Preoperative VAS
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.813
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: Day1, Sleep amout

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    End point title
    		 Day1, Sleep amout
    End point description
    End point type
    Secondary
    End point timeframe
    Night before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    7 (6.5 to 8.3)
    6.5 (6.3 to 7)
    Statistical analysis title
    		 Sleep amount
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.165
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day1, Number of awakenings

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    End point title
    		 Day1, Number of awakenings
    End point description
    End point type
    Secondary
    End point timeframe
    Night before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: No. of awakenings
        median (inter-quartile range (Q1-Q3))
    1 (1 to 2)
    2 (1 to 3)
    Statistical analysis title
    		 Day1, Awakenings
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.725
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day 1, Time awake

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    End point title
    		 Day 1, Time awake
    End point description
    End point type
    Secondary
    End point timeframe
    Night before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Minutes
        median (inter-quartile range (Q1-Q3))
    7 (3 to 15)
    10 (2 to 38)
    Statistical analysis title
    		 Time awake
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.415
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day 1, Karolinska sleepiness scale

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    End point title
    		 Day 1, Karolinska sleepiness scale
    End point description
    End point type
    Secondary
    End point timeframe
    Measured in the morning after sleep
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Karolinska sleepiness scale
        median (inter-quartile range (Q1-Q3))
    3 (2 to 3)
    3 (2 to 3)
    No statistical analyses for this end point

    Secondary: Day 1, Karolinska sleepiness scale

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    End point title
    		 Day 1, Karolinska sleepiness scale
    End point description
    End point type
    Secondary
    End point timeframe
    In the morning after sleep
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Karolinska Sleepiness Scale
        median (inter-quartile range (Q1-Q3))
    3 (2 to 3)
    3 (2 to 3)
    Statistical analysis title
    		 Day 1, Karonlinska sleepiness
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.652
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day 1, Fatigue

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    End point title
    		 Day 1, Fatigue
    End point description
    End point type
    Secondary
    End point timeframe
    Measured in the morning before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: 10 point scale
        median (inter-quartile range (Q1-Q3))
    3 (2 to 3)
    3 (2 to 4)
    Statistical analysis title
    		 Day1, Fatigue
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.362
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day1, VAS sleep quality

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    End point title
    		 Day1, VAS sleep quality
    End point description
    0 Being best sleep quality and 100 being the worst
    End point type
    Secondary
    End point timeframe
    Measured the morning before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    24 (15 to 33)
    34 (13 to 52)
    Statistical analysis title
    		 Day1, VAS sleep quality
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.346
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day 1, VAS comfort

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    End point title
    		 Day 1, VAS comfort
    End point description
    0 being very comfortable and 100 being very uncomfortable.
    End point type
    Secondary
    End point timeframe
    Measured in the morning before surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    25 (15 to 33)
    22 (15 to 29)
    Statistical analysis title
    		 Day 1, VAS comfgort
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.678
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, Sleep amount

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    End point title
    		 Day2, Sleep amount
    End point description
    End point type
    Secondary
    End point timeframe
    Measured in the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    7 (5 to 7.6)
    6.3 (5.3 to 8.2)
    Statistical analysis title
    		 Day2, Sleep amount
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.925
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, no. of awakenings

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    End point title
    		 Day2, no. of awakenings
    End point description
    End point type
    Secondary
    End point timeframe
    Measured in the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: no. of awakenings
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    3 (1 to 5)
    Statistical analysis title
    		 Day2, No. of awakenings
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.664
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, time awake during night

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    End point title
    		 Day2, time awake during night
    End point description
    End point type
    Secondary
    End point timeframe
    Measured in the morning the day after surgery - questionnaire data
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    45 (10 to 100)
    25 (5 to 50)
    Statistical analysis title
    		 Day2, Time awake during night
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.257
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, Karolinska sleepiness scale

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    End point title
    		 Day2, Karolinska sleepiness scale
    End point description
    End point type
    Secondary
    End point timeframe
    Measured by questionnaire the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: Karolinska sleepniess scale
        median (inter-quartile range (Q1-Q3))
    3 (2 to 7)
    3 (3 to 6)
    Statistical analysis title
    		 Day2, Karonlinska sleepiness
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.984
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, Fatigue

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    End point title
    		 Day2, Fatigue
    End point description
    End point type
    Secondary
    End point timeframe
    Measured by questionnaire the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: 10 point scale
        median (inter-quartile range (Q1-Q3))
    5 (3 to 6)
    4 (3 to 5)
    Statistical analysis title
    		 Day2, Fatigue
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.565
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, VAS sleep quality

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    End point title
    		 Day2, VAS sleep quality
    End point description
    VAS scale 0= best sleep, 100= worst sleep
    End point type
    Secondary
    End point timeframe
    Measured by questionnaire the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    44 (22 to 57)
    33 (14 to 53)
    Statistical analysis title
    		 Day2, VAS sleep quality
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.428
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Day2, Comfort

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    End point title
    		 Day2, Comfort
    End point description
    VAS scale, 0=Best comfort, 100= very uncomfortable
    End point type
    Secondary
    End point timeframe
    Questionnaire the morning the day after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    35 (22 to 63)
    40 (29 to 61)
    Statistical analysis title
    		 Day2, VAS comfort
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.925
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Propofol intraoperative use

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    End point title
    		 Propofol intraoperative use
    End point description
    End point type
    Secondary
    End point timeframe
    Noted after anaesthesia
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    499 (401 to 517)
    449 (410 to 486)
    Statistical analysis title
    		 Propofol use
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.101
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Remifentanil intraoperative use

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    End point title
    		 Remifentanil intraoperative use
    End point description
    End point type
    Secondary
    End point timeframe
    Measured after anaesthesia
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: microgram(s)
        median (inter-quartile range (Q1-Q3))
    1342 (1153 to 1725)
    1330 (1045 to 1582)
    Statistical analysis title
    		 Remifentanil use
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.528
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Opioid used in anaesthesia recovery

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    End point title
    		 Opioid used in anaesthesia recovery
    End point description
    Peroral oxycodone usage.
    End point type
    Secondary
    End point timeframe
    Measured from the end of general anaesthesia to the patient being discharged from hospital
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    16
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    5 (0 to 8)
    0 (0 to 5)
    Statistical analysis title
    		 Rescue oxycodone
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.182
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total oxycodone used 24 hours after surgery

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    End point title
    		 Total oxycodone used 24 hours after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Total opiod used 24 hours after surgery
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    5 (5 to 15)
    7.5 (5 to 10)
    Statistical analysis title
    		 Total opioid 24 hours
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.76
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Length of stay

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    End point title
    		 Length of stay
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from time between start surgery and hospital discharge
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    16
    17
    Units: hours
        median (inter-quartile range (Q1-Q3))
    3 (2.6 to 3.9)
    3 (2.5 to 3)
    Statistical analysis title
    		 Length of stay
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.477
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were only monitored actively during the study period. Melatonin has an elimination half-life of 30-60 minutes.
    Adverse event reporting additional description
    Information on adverse events were collected using an electronic questionnaire and by a telephone interview after each participant's completion of the trial. However, no adverse event were described either during or after the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 The group of patients receiving melatonin treatment related to surgery

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Melatonin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Melatonin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    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: Oral melatonin results in few and mild adverse effects. The few known adverse effects include drowsiness and dizziness. These are symptoms that are diffucult to distinguish from the normal effects of general anesthesia, and thus, we have not been able to record any adverse effects in the present study. Multiple previously pubslihed RCTs have reported no adverse effects of oral melatonin, even when administered in doses more than double of what was used in our study.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Oct 2020
    In the original protocol for this RCT, only female patients undergoing cosmetic breast enhancement surgery were eligible for inclusion. However, due to issues with patient recruitment, the protocol was amended in October 2020 to change the study population to male patients undergoing elective hernia surgery.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Apr 2020
    Due to issues with participant recruitment, the trial was put on a temporary hiatus and the protocol was amended to rectify these issues.
    07 Oct 2020

    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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