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    Clinical Trial Results:
    Perioperativ installation of ropivacain in mastectomy – with or without axillary lymph node dissection after sentinel node diagnostics or known lymph node metastasis – A double-blind, randomized clinical trial of the effect on postoperative pain

    Summary
    EudraCT number
    		 2012-001557-46
    Trial protocol
    		 DK  
    Global end of trial date
    01 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2021
    First version publication date
    12 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The Good Clinical Practice Unit - Odense: 12.005, Danish Medicines Agency: LMST2012053739, The Regional Committees on Health Research Ethics : S-20120095, The Danish Data Protection Agency: 2012-001557-46
    Sponsors
    Sponsor organisation name
    Odense Universityhospital
    Sponsor organisation address
    Sdr. Boulevard 25, Odense C, Denmark, 5000
    Public contact
    Søren Rune Larsen, Odense Universitetshospital, Department of Anesthesiology and Intensive Care Medicine, +45 65412063, soeren.rune.larsen@rsyd.dk
    Scientific contact
    Søren Rune Larsen, Odense Universitetshospital, Department of Anesthesiology and Intensive Care Medicine, +45 65412063, soeren.rune.larsen@rsyd.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
    29 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the effect on pain relief, after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation. The effect is rated via VAS-score (Visual Analogue Scale) an modified VAS-score
    Protection of trial subjects
    Close observation by Anestehetic personal and postoperativecare nurses, and monitoring of vital signs parametres.
    Background therapy
    		 Standard treatment beside study drug
    Evidence for comparator
    		 Ropivacaine compared to placebo (Isotonic Saline)
    Actual start date of recruitment
    23 Nov 2012
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    19
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult females undergoing unilateral mastectomy with or without axillary lymph node dissection after sentinel lymph node biopsy or known lymph node metastases at the Hospital of South West Jutland (located in Esbjerg - Denmark). In the period from June 2012 to December 2014

    Pre-assignment
    Screening details
    		 Evaluation by anesthesiologist

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Installation of Ropivacaine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacain "Fresenius Kabi": 2 mg/ml
    Investigational medicinal product code
    i
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use, Subdermal use
    Dosage and administration details
    Installation of 100 ml Ropivacaine 2 mg/ml added adrenaline to a concentration of 2 µg/ml into the mastectomy cavity .

    Arm title
    		 Placebo
    Arm description
    		 Installation of isotonic saline to the mastectomy cavity
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumklorid 9 mg/ml "Fresenius Kabi"
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use, Subdermal use
    Dosage and administration details
    100 ml of Natriumklorid 9 mg/ml added adrenaline to a concentration of 2 µg/ml installed into the mastectomy cavity.

    Number of subjects in period 1
    		Active Placebo
    Started
    17
    13
    Completed
    17
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Installation of Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Installation of isotonic saline to the mastectomy cavity

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 17 13 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 9 19
        From 65-84 years
    		 7 4 11
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 17 13 30
        Male
    		 0 0 0
    Smoker
    Units: Subjects
        Smoker
    		 4 3 7
        Non-Smoker
    		 9 9 18
        Former Smoker
    		 4 1 5
    PONV
    Previous PostOperative Nausea or Vomiting
    Units: Subjects
        Yes
    		 1 3 4
        No
    		 16 10 26
    Motion sickness
    Tendency to Motion Sickness
    Units: Subjects
        Yes
    		 4 3 7
        No
    		 12 9 21
        Not Done
    		 1 1 2
    Allergies
    Units: Subjects
        Food
    		 1 1 2
        Medicine
    		 2 3 5
        Non
    		 14 9 23
    Type of Surgery
    Unilateral mastectomy with or without axillary lymph node dissection
    Units: Subjects
        With axillary lymph node dissection
    		 6 6 12
        Without axillary lymph node dissection
    		 11 7 18
    History of pain
    Does the patient have a history of ongoing pain up to surgery.
    Units: Subjects
        Yes
    		 3 2 5
        No
    		 13 11 24
        Not registered
    		 1 0 1
    Preoperative Paracetamol
    Has the patient received paracetamol for postoperative pain relief? Given as preoperative oral paracetamol 1000 mg or perioperative intravenous paracetamol 1000 mg
    Units: Subjects
        Preoperative oral administration
    		 9 6 15
        Perioperative intravenous administrationa
    		 7 6 13
        Not done
    		 1 1 2
    Preoperative Oral Fluide intake
    Preoperative Oral Fluid intake of minimum 200 ml in the fasting period and until 2 hours preoperative
    Units: Subjects
        Yes
    		 9 8 17
        No
    		 7 4 11
        Not registered
    		 1 1 2
    Race
    Units: Subjects
        Caucasian
    		 16 13 29
        Asian
    		 1 0 1
    Dexamethasone
    Perioperativt dexamethasone intravenous 4 mg
    Units: Subjects
        Yes
    		 17 12 29
        No
    		 0 1 1
    Ondansetron
    Perioperative ondansetron intravenous 4 mg
    Units: Subjects
        Yes
    		 17 11 28
        No
    		 0 2 2
    Comorbidity - Cardiovascular or Lung Disease
    One or more of the following comorbidity’s: Arterial Hypertension, Atrial fibrillation, Asthma, Chronic obstructive pulmonary disease, Peripheral edema and/or Hypercholesterolemia.
    Units: Subjects
        Yes
    		 7 5 12
        No
    		 10 8 18
    Comorbidity - Dysplasia or Malignancy
    One or more of the following comorbidity’s: Lymphoma, Lung carcinoma, Uterine cervical dysplasia, Oral mucosal disorders and/or Ascites of unknown origin.
    Units: Subjects
        Yes
    		 2 4 6
        No
    		 15 9 24
    Comorbidity - Musculoskeletal Disorder
    One or more of the following comorbidity’s: Disc prolapse, Osteoarthritis, Rheumatoid arthritis, Gout arthritis, Osteoporosis and/or Torticollis.
    Units: Subjects
        Yes
    		 5 3 8
        No
    		 12 10 22
    Comorbidity - Mental Disorder
    Comorbidity - Depression Disorder
    Units: Subjects
        Yes
    		 1 0 1
        No
    		 16 13 29

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Installation of Ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 Installation of isotonic saline to the mastectomy cavity

    Primary: Pain assesment postoperatively

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    End point title
    		 Pain assesment postoperatively
    End point description
    To investigate the effect on pain relief, after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation. The effect is rated via median VAS-score (VisualAnalogue Scale) for all measurements in each group.
    End point type
    Primary
    End point timeframe
    Postoperatively from arriving at the PACU untill 24 hours postoperatively
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: VAS
        number (not applicable)
    1.63
    1.46
    Statistical analysis title
    		 Wilcoxon non parametric test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.99
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Postoperative use of analgesia

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    End point title
    		 Postoperative use of analgesia
    End point description
    To investigate the postoperatively use of opioid (morphine equivalents in mg), after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection. The effect is rated via median administrated amounts of morphine equivalents in mg in each group.
    End point type
    Secondary
    End point timeframe
    Postoperatively from arriving at the PACU untill 24 hours postoperatively
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: Mg
        number (not applicable)
    16
    44
    Statistical analysis title
    		 Wilcoxon non parametric test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0804
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Effect on PONV (Postoperative nausea and vomiting)

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    End point title
    		 Effect on PONV (Postoperative nausea and vomiting)
    End point description
    To investigate the effect on PONV (Postoperative Nausea and Vomiting) after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation. The effect is rated via median of all measured VAS-score (VisualAnalogue Scale) in each group. Analyzed as yes or no
    End point type
    Secondary
    End point timeframe
    Postoperatively from arriving at the PACU untill 24 hours postoperatively
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: Yes or No
        Yes
    4
    3
        No
    13
    10
    Statistical analysis title
    		 Fishers exact test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.66
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Use of antiemetic

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    End point title
    		 Use of antiemetic
    End point description
    To investigate the use of antiemetics after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation. The effect is rated via mean of the converting antiemetic factor (as described by the antiemetic equivalences table in the protocol) in each group. Then recorded as yes or no
    End point type
    Secondary
    End point timeframe
    Postoperatively from arriving at the PACU untill 24 hours postoperatively
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: Yes or No
        Yes
    1
    1
        No
    16
    12
    Statistical analysis title
    		 Fishers exact test
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.687
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    The effect is rated via median length of hospital stay in minutes in each group.
    End point type
    Secondary
    End point timeframe
    Postoperatively from arriving at the PACU untill discharge from hospital
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: minute
        number (not applicable)
    2805
    2713
    Statistical analysis title
    		 Wilcoxon non parametric test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8691
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time till first mobilisation

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    End point title
    		 Time till first mobilisation
    End point description
    The effect is rated via median Time till first mobilisation in minutes in each group.
    End point type
    Secondary
    End point timeframe
    Postoperatively from arriving at the PACU untill first mobilisation
    End point values
    		 Active Placebo
    Number of subjects analysed
    17
    13
    Units: minute
        number (not applicable)
    100
    130
    Statistical analysis title
    		 Wilcoxon non parametric test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.406
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Yearly report to the Danish authorites.
    Adverse event reporting additional description
    All Adverse Events is registred emidently in the CRF and reported to the Danish authorites in the yearly report of Adverse Events. All Serious Adverse Events is registred emidently in the CRF and reported to the Danish authorites within the first 24 hours. No Adverse Events or Serious Adverse Events has occurred in the study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Because the procedure is a low risk procedure, where installation is done through the existing surgical drain, and only half of the expected numbers of patients has gone through the study, no adverse event and no non-serious adverse event has occurred.

    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? Yes
    Date
    Interruption
    Restart date
    01 Sep 2018
    Trial has been terminated early due to lack of patients going through mastectomy at the trial site in Esbjerg. Through the last 2 years of the trial periode, there were not included any contestants to the trial. As it was not possible to include a other trial site, it was decided to terminate the trial early.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Trial has been terminated early due to lack of patients going through mastectomy at the trial site in Esbjerg, leading to a smaller number of subjects analysed.
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