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    Clinical Trial Results:
    Does preperitoneal local anesthesia in laparoscopic gastric bypass surgery reduce postoperative pain and opioid consumption?

    Summary
    EudraCT number
    		 2012-002618-38
    Trial protocol
    		 NL  
    Global end of trial date
    01 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2017
    First version publication date
    23 Sep 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AnesBar01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rijnstate Hospital, department of Anesthesia
    Sponsor organisation address
    Wagnerlaan 55, Arnhem, Netherlands,
    Public contact
    Dr. E.T. Kamphuis, anesthesiologist, Rijnstate Hospital, department of Anesthesia, +31 0880058888, ekamphuis@rijnstate.nl
    Scientific contact
    Dr. E.T. Kamphuis, anesthesiologist, Rijnstate Hospital, department of Anesthesia, +31 0880058888,
    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
    07 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the postoperative opioid consumption and pain after laparoscopic bariatric surgery. Our hypothesis is that less opioids will be consumed by patients in the group receiving local anesthetics compared to normal saline.
    Protection of trial subjects
    As this is a trial of analgesics, an escape plan for postoperative pain was in place to make sure patients would not suffer from more pain than to be expected after such a procedure.
    Background therapy
    		 Patients received the usual analgesic and anti-emetic medication alongside the intervention. At the recovery: − NRS > 3 and/or when the patient tells he needs more analgesics: morfine 2.5mg IV − Antihypertensive medication: clonidine 75 micrograms − Anti-emetics: ondansetron 4mg, droperidol 1.25mg IV. Anti-emetics will be given on demand of the patient. At the ward: − Paracetamol 4dd 1000mg per os − Morfine 10mg subcutaneous injection at the day of surgery or tramadol 50mg the day(s) after surgery: when the patient tells he needs more analgesics. There will be a minimum of one hour between gifts of analgesics and nurses will test if patients are not too sedated to make sure a patient does not get an overdose. − Anti-emetics: ondansetron 4mg, droperidol 1.25mg, metoclopramid 20mg iv. Anti-emetics will be given on demand of the patient.
    Evidence for comparator
    		 Normal saline is used as a comparator. This has no analgesic effects.
    Actual start date of recruitment
    21 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recuitment took place from 21/05/2014-15/07/2014 at the Rijnstate Hospital in Arnhem, the Netherlands

    Pre-assignment
    Screening details
    		 201 patients were screened. Exclusion of patients: - No informed consent: 48 - More extensive surgery: 35 - Chronic pain patients: 15 - Morphine intolerance: 3

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Medication was packaged in normal 20ml syringes with a label saying "bupivacaine/placebo" for every patient. It was not possible to distinguish one from the other. The randomisation code was not broken until the last patient had had their last visit in our hospital.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bupivacaine
    Arm description
    		 Patients receiving investigational product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion, Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Bupivacaine 5mg/ml, a total of 30-40ml by pre peritoneal at the incision ports of surgery

    Arm title
    		 Placebo
    Arm description
    		 Patients receiving normal saline as a placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Normal saline, NaCl 0.9%, injected 30-40ml pre peritoneal at the incision ports of surgery

    Number of subjects in period 1
    		Bupivacaine Placebo
    Started
    50
    50
    Completed
    48
    48
    Not completed
    2
    2
         No surgery at all
    1
    -
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bupivacaine
    Reporting group description
    		 Patients receiving investigational product

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving normal saline as a placebo

    Reporting group values
    		 Bupivacaine Placebo Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 50 50 100
        From 65-84 years
    		 0 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 45.2 ( 10 ) 44.8 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 38 74
        Male
    		 12 9 21
        Not recorded
    		 2 3 5
    ASA classification
    Classification used in anaesthesia to assess a global idea of patients' health. ASA 1: healthy patient ASA 2: patient with a mild systemic disease ASA 3: patient with a severe systemic disease ASA 4: patient with a severe systemic disease that is a constant threat to life ASA 5: a moribund patient who is not expected to survive without the operation
    Units: Subjects
        ASA 1
    		 5 7 12
        ASA 2
    		 41 37 78
        ASA 3
    		 2 3 5
        ASA 4
    		 0 0 0
        ASA 5
    		 0 0 0
        Not recorded
    		 2 3 5
    Chronic pain in past
    Whether patients had experienced chronic pain in the past. Defined by using opioids for a longer period of time and being treated by a pain specialist.
    Units: Subjects
        Yes
    		 19 25 44
        No
    		 29 22 51
        Not recorded
    		 2 3 5
    Abdominal surgery in the past
    Units: Subjects
        Yes
    		 27 23 50
        No
    		 21 24 45
        Not recorded
    		 2 3 5
    Type of surgery
    Units: Subjects
        Laparoscopic sleeve gastrectomy
    		 2 3 5
        Laparoscopic gastric bypass
    		 46 44 90
        Not recorded
    		 2 3 5
    Weight
    Units: Kg
        geometric mean (standard deviation)
    		 125.6 ( 18.7 ) 128.5 ( 20.5 ) -
    Height
    Units: Meters
        geometric mean (standard deviation)
    		 171 ( 8.8 ) 170 ( 8.1 ) -
    Body Mass Index
    Units: kg/m2
        geometric mean (standard deviation)
    		 42.8 ( 5 ) 44.5 ( 5.8 ) -
    Studymedication
    The amount of study medication given in milliliters
    Units: millilitres
        median (inter-quartile range (Q1-Q3))
    		 37 (36 to 40) 39 (35 to 40) -
    Duration of surgery
    Units: Minutes
        geometric mean (standard deviation)
    		 49.3 ( 14.6 ) 50.9 ( 17.26 ) -

    End points

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    End points reporting groups
    Reporting group title
    Bupivacaine
    Reporting group description
    		 Patients receiving investigational product

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving normal saline as a placebo

    Primary: Morphine at the recovery in mg

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    End point title
    		 Morphine at the recovery in mg
    End point description
    End point type
    Primary
    End point timeframe
    During time spent at the recovery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    2.5 (0 to 5)
    5 (2.5 to 7.5)
    Statistical analysis title
    		 Analysis of morphine use at the recovery
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Morphine at the ward in mg

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    End point title
    		 Morphine at the ward in mg
    End point description
    End point type
    Primary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Analysis of morphine use at the ward
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Tramadol use at the ward in mg

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    End point title
    		 Tramadol use at the ward in mg
    End point description
    End point type
    Primary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    0 (0 to 10)
    0 (0 to 10)
    Statistical analysis title
    		 Analysis of tramadol use at the ward
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Preoperative pain, at the preoperative policlinic

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    End point title
    		 Preoperative pain, at the preoperative policlinic
    End point description
    End point type
    Primary
    End point timeframe
    Pain before surgery, at the policlinic, at rest
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        geometric mean (standard error)
    1.15 ( 0.24 )
    1.89 ( 0.24 )
    Attachments
    		 Pain at rest
    Statistical analysis title
    		 Analysis pain at the policlinic
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Postoperative pain, right before surgery

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    End point title
    		 Postoperative pain, right before surgery
    End point description
    End point type
    Primary
    End point timeframe
    Pain at the holding area, right before surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        geometric mean (standard error)
    0.19 ( 0.24 )
    0.43 ( 0.24 )
    Statistical analysis title
    		 Analysis of pain
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=0, arrival at the recovery

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    End point title
    		 Pain at T=0, arrival at the recovery
    End point description
    End point type
    Primary
    End point timeframe
    Pain at arrival at the recovery after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    47 [1]
    47
    Units: 10
        geometric mean (standard error)
    3.43 ( 0.24 )
    4.32 ( 0.24 )
    Notes
    [1] - 1 missing patient
    Statistical analysis title
    		 Analysis of pain
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=15, 15min after arrival at the recovery

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    End point title
    		 Pain at T=15, 15min after arrival at the recovery
    End point description
    End point type
    Primary
    End point timeframe
    15 min after arrival at the recovery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        geometric mean (standard error)
    4.33 ( 0.24 )
    5.53 ( 0.24 )
    Statistical analysis title
    		 Analysis of pain at T=15
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=30, 30 min after surgery at arrival at the recovery

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    End point title
    		 Pain at T=30, 30 min after surgery at arrival at the recovery
    End point description
    End point type
    Primary
    End point timeframe
    30 min after surgery at the recovery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        geometric mean (standard error)
    4.33 ( 0.24 )
    5.6 ( 0.24 )
    Statistical analysis title
    		 Analysis of pain at T=30
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=45, 45 min after arrival at the recovery

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    End point title
    		 Pain at T=45, 45 min after arrival at the recovery
    End point description
    End point type
    Primary
    End point timeframe
    45min after arrival at the recovery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    46
    Units: 10
        geometric mean (standard error)
    3.98 ( 0.24 )
    5.14 ( 0.24 )
    Statistical analysis title
    		 Analysis of pain at T=45
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=60, 60min after arrival at the recovery

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    End point title
    		 Pain at T=60, 60min after arrival at the recovery
    End point description
    End point type
    Primary
    End point timeframe
    60min after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    42
    41
    Units: 10
        geometric mean (standard error)
    3.65 ( 0.25 )
    4.52 ( 0.25 )
    Statistical analysis title
    		 Analysis of pain at T=60
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=2, at rest

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    End point title
    		 Pain at T=2, at rest
    End point description
    End point type
    Primary
    End point timeframe
    2 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    47
    42
    Units: 10
        geometric mean (standard error)
    3.76 ( 0.24 )
    4.06 ( 0.25 )
    Statistical analysis title
    		 Analysis of pain at T=2
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.39
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=2, at movement/mobilisation

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    End point title
    		 Pain at T=2, at movement/mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    2 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    43
    41
    Units: 10
        geometric mean (standard error)
    3.94 ( 0.21 )
    4.24 ( 0.21 )
    Statistical analysis title
    		 Analysis of pain at T=2, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=4, at rest

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    End point title
    		 Pain at T=4, at rest
    End point description
    End point type
    Primary
    End point timeframe
    4 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    44
    Units: 10
        geometric mean (standard error)
    3.17 ( 0.24 )
    3.51 ( 0.25 )
    Statistical analysis title
    		 Analysis of pain at T=4, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=4, at movement/mobilisation

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    End point title
    		 Pain at T=4, at movement/mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    4 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    43
    44
    Units: 10
        geometric mean (standard error)
    3.26 ( 0.21 )
    3.84 ( 0.21 )
    Statistical analysis title
    		 Analysis of pain at T=4, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=6, at rest

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    End point title
    		 Pain at T=6, at rest
    End point description
    End point type
    Primary
    End point timeframe
    6 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    44
    43
    Units: 10
        geometric mean (standard error)
    3.02 ( 0.25 )
    3.35 ( 0.25 )
    Statistical analysis title
    		 Analysis of pain at T=6, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=6, at mobilisation

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    End point title
    		 Pain at T=6, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    6 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    42
    42
    Units: 10
        geometric mean (standard error)
    3.1 ( 0.21 )
    3.73 ( 0.21 )
    Statistical analysis title
    		 Analysis of pain at T=6,mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=8, at rest

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    End point title
    		 Pain at T=8, at rest
    End point description
    End point type
    Primary
    End point timeframe
    8 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    44
    40
    Units: 10
        geometric mean (standard error)
    2.87 ( 0.25 )
    3.09 ( 0.26 )
    Statistical analysis title
    		 Analysis of pain at T=8, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=8, at mobilisation

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    End point title
    		 Pain at T=8, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    8 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    42
    40
    Units: 10
        geometric mean (standard error)
    3.26 ( 0.21 )
    3.16 ( 0.21 )
    Statistical analysis title
    		 Analysis of pain at T=8, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=10, at rest

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    End point title
    		 Pain at T=10, at rest
    End point description
    End point type
    Primary
    End point timeframe
    10 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    39
    40
    Units: 10
        geometric mean (standard error)
    2.5 ( 0.26 )
    3 ( 0.26 )
    Statistical analysis title
    		 Analysis of pain at T=10, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=10, at mobilisation

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    End point title
    		 Pain at T=10, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    10 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    35
    37
    Units: 10
        geometric mean (standard error)
    3.01 ( 0.22 )
    3.31 ( 0.22 )
    Statistical analysis title
    		 Analysis of pain at T=10, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=12, at rest

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    End point title
    		 Pain at T=12, at rest
    End point description
    End point type
    Primary
    End point timeframe
    12 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    40
    33
    Units: 10
        geometric mean (standard error)
    2.9 ( 0.26 )
    3.11 ( 0.28 )
    Statistical analysis title
    		 Analysis of pain at T=12, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=12, at mobilisation

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    End point title
    		 Pain at T=12, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    12 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    36
    30
    Units: 10
        geometric mean (standard error)
    3.22 ( 0.22 )
    3.28 ( 0.24 )
    Statistical analysis title
    		 Analysis of pain at T=12, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.87
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=14, at rest

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    End point title
    		 Pain at T=14, at rest
    End point description
    End point type
    Primary
    End point timeframe
    14 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    41
    39
    Units: 10
        geometric mean (standard error)
    2.78 ( 0.25 )
    2.96 ( 0.26 )
    Statistical analysis title
    		 Pain at T=14, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=14, at mobilisation

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    End point title
    		 Pain at T=14, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    14 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    38
    38
    Units: 10
        geometric mean (standard error)
    3.11 ( 0.22 )
    3.24 ( 0.22 )
    Statistical analysis title
    		 Pain at T=14, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=16, at rest

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    End point title
    		 Pain at T=16, at rest
    End point description
    End point type
    Primary
    End point timeframe
    16 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    43
    Units: 10
        geometric mean (standard error)
    2.8 ( 0.24 )
    2.99 ( 0.25 )
    Statistical analysis title
    		 Pain at T=16, at rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=16, at mobilisation

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    End point title
    		 Pain at T=16, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    16 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    42
    40
    Units: 10
        geometric mean (standard error)
    2.99 ( 0.21 )
    3.23 ( 0.21 )
    Statistical analysis title
    		 Pain at T=16, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=18, at rest

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    End point title
    		 Pain at T=18, at rest
    End point description
    End point type
    Primary
    End point timeframe
    18 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    43
    Units: 10
        geometric mean (standard error)
    2.65 ( 0.24 )
    2.91 ( 0.25 )
    Statistical analysis title
    		 Pain at T=18, at rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.64
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=18, at mobilisation

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    End point title
    		 Pain at T=18, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    18 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    42
    Units: 10
        geometric mean (standard error)
    2.79 ( 0.2 )
    3.25 ( 0.21 )
    Statistical analysis title
    		 Pain at T=18, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=20, at rest

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    End point title
    		 Pain at T=20, at rest
    End point description
    End point type
    Primary
    End point timeframe
    20 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        geometric mean (standard error)
    2.38 ( 0.24 )
    2.72 ( 0.24 )
    Statistical analysis title
    		 Pain at T=20, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=20, at mobilisation

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    End point title
    		 Pain at T=20, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    20 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    47
    46
    Units: 10
        geometric mean (standard error)
    2.63 ( 0.2 )
    3.1 ( 0.2 )
    Statistical analysis title
    		 Pain at T=20, mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=22, at rest

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    End point title
    		 Pain at T=22, at rest
    End point description
    End point type
    Primary
    End point timeframe
    22 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    47
    46
    Units: 10
        geometric mean (standard error)
    2.32 ( 0.24 )
    2.46 ( 0.24 )
    Statistical analysis title
    		 Pain at T=22, rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=22, at mobilisation

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    End point title
    		 Pain at T=22, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    22 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    45
    Units: 10
        geometric mean (standard error)
    2.62 ( 0.2 )
    2.85 ( 0.21 )
    Statistical analysis title
    		 Pain at T=22, at mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=24, at rest

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    End point title
    		 Pain at T=24, at rest
    End point description
    End point type
    Primary
    End point timeframe
    24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    46
    Units: 10
        geometric mean (standard error)
    2.15 ( 0.24 )
    2.39 ( 0.24 )
    Statistical analysis title
    		 Pain at T=24, at rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.47
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain at T=24, at mobilisation

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    End point title
    		 Pain at T=24, at mobilisation
    End point description
    End point type
    Primary
    End point timeframe
    24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    46
    45
    Units: 10
        geometric mean (standard error)
    2.46 ( 0.2 )
    2.65 ( 0.21 )
    Statistical analysis title
    		 Pain at T=24, at mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clonidine at recovery in ug

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    End point title
    		 Clonidine at recovery in ug
    End point description
    End point type
    Secondary
    End point timeframe
    During time spent at the recovery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    0 (0 to 75)
    0 (0 to 113)
    Statistical analysis title
    		 Analysis of clonidine use at the recovery
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time to rescue medication in minutes

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    End point title
    		 Time to rescue medication in minutes
    End point description
    End point type
    Secondary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    21 (14 to 28)
    19 (9 to 28)
    Statistical analysis title
    		 Analysis of time to rescue medication
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Opioids needed

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    End point title
    		 Opioids needed
    End point description
    End point type
    Secondary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    34
    38
        No
    14
    9
    Statistical analysis title
    		 Analysis of opioids needed or not
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Rescue medication needed

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    End point title
    		 Rescue medication needed
    End point description
    End point type
    Secondary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    35
    40
        No
    13
    7
    Statistical analysis title
    		 Analysis of rescue medication needed or not
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Extra antiemetic's needed

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    End point title
    		 Extra antiemetic's needed
    End point description
    End point type
    Secondary
    End point timeframe
    In the first 24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    20
    25
        No
    28
    22
    Statistical analysis title
    		 Analysis of extra antiemetic's needed or not
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Mobilisation possible within two hours

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    End point title
    		 Mobilisation possible within two hours
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    41
    42
        No
    3
    4
        Not recorded
    4
    1
    Statistical analysis title
    		 Analysis of mobilisation possible
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Trouble falling asleep

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    End point title
    		 Trouble falling asleep
    End point description
    End point type
    Secondary
    End point timeframe
    First night after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    14
    24
        No
    34
    23
    Statistical analysis title
    		 Analysis of trouble falling asleep
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Waking up because of pain

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    End point title
    		 Waking up because of pain
    End point description
    End point type
    Secondary
    End point timeframe
    First night after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 100
        Yes
    19
    24
        No
    29
    23
    Statistical analysis title
    		 Analysis of waking up because of pain
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.22
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Satisfaction with pain treatment

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    End point title
    		 Satisfaction with pain treatment
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        median (inter-quartile range (Q1-Q3))
    8 (7 to 10)
    8 (7 to 9)
    Statistical analysis title
    		 Analysis of satisfaction with pain treatment
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of stay, recovery (minutes)

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    End point title
    		 Duration of stay, recovery (minutes)
    End point description
    End point type
    Secondary
    End point timeframe
    First hours after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 200
        median (inter-quartile range (Q1-Q3))
    92 (82 to 106)
    101 (89 to 120)
    Statistical analysis title
    		 Analysis of duration of stay, recovery
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of stay in the hospital (days)

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    End point title
    		 Duration of stay in the hospital (days)
    End point description
    End point type
    Secondary
    End point timeframe
    Days after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    48
    47
    Units: 10
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1)
    Statistical analysis title
    		 Analysis of duration of stay, hospital stay
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.76
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain after surgery

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    End point title
    		 Pain after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    One year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    47
    Units: 100
        Much less
    17
    8
        Less
    8
    11
        Same
    16
    20
        More
    4
    5
        Much more
    0
    3
    Statistical analysis title
    		 Analysis of change in pain after surgery
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Effect of pain on daily activities

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    End point title
    		 Effect of pain on daily activities
    End point description
    End point type
    Secondary
    End point timeframe
    One year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    44
    47
    Units: 10
        Much less
    15
    7
        Less
    11
    9
        Same
    16
    22
        More
    2
    8
        Much more
    0
    1
    Statistical analysis title
    		 Analysis of effect on daily living
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change in use of painkillers

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    End point title
    		 Change in use of painkillers
    End point description
    Change in use of painkillers as reported by the patients themselves.
    End point type
    Secondary
    End point timeframe
    One year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    47
    Units: 10
        Much less
    7
    2
        Less
    12
    12
        Same
    25
    25
        More
    1
    8
        Much more
    0
    0
    Statistical analysis title
    		 Analysis of change in use of painkillers
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Pain at T=2wk, at rest

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    End point title
    		 Pain at T=2wk, at rest
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    42
    42
    Units: 10
        geometric mean (standard error)
    0.08 ( 0.25 )
    0.28 ( 0.25 )
    Statistical analysis title
    		 Pain at T=2wk, at rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.57
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain at T=2wk, at mobilisation

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    End point title
    		 Pain at T=2wk, at mobilisation
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    41
    40
    Units: 10
        geometric mean (standard error)
    0.11 ( 0.21 )
    0.24 ( 0.21 )
    Statistical analysis title
    		 Pain at T=2wk, at mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain at T=6wk, at rest

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    End point title
    		 Pain at T=6wk, at rest
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    31
    29
    Units: 10
        geometric mean (standard error)
    0.002 ( 0.28 )
    0.24 ( 0.29 )
    Statistical analysis title
    		 Pain at T=6wk, at rest
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.55
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain at T=6wk, at mobilisation

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    End point title
    		 Pain at T=6wk, at mobilisation
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    30
    27
    Units: 10
        geometric mean (standard error)
    0.04 ( 0.23 )
    0.09 ( 0.24 )
    Statistical analysis title
    		 Pain at T=6wk, at mobilisation
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain one year after surgery

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    End point title
    		 Pain one year after surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Pain on a numeric rating scale one year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    47
    Units: 10
        geometric mean (standard deviation)
    1.36 ( 2.2 )
    2.7 ( 2.8 )
    Statistical analysis title
    		 Pain one year after surgery
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Prevalence NRS >4

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    End point title
    		 Prevalence NRS >4
    End point description
    End point type
    Secondary
    End point timeframe
    1 year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    47
    Units: 100
        NRS >4
    6
    19
        NRS <4
    32
    28
    Statistical analysis title
    		 Prevalence NRS >4
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Fisher exact
    Confidence interval

    Secondary: NRS >7

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    End point title
    		 NRS >7
    End point description
    End point type
    Secondary
    End point timeframe
    1 year after surgery
    End point values
    		 Bupivacaine Placebo
    Number of subjects analysed
    45
    47
    Units: 100
        NRS >7
    3
    6
        NRS <7
    42
    41
    Statistical analysis title
    		 Prevalence NRS >7
    Comparison groups
    Bupivacaine v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 hours after surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Placebogroup
    Reporting group description
    		 -

    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: No non-serious adverse events were recorded during the trial period.
    Serious adverse events
    		 Placebogroup
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Re-operation
    Additional description: Patient needed reoperation because of postoperative bleeding complication
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebogroup
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (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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