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    Clinical Trial Results:
    Prospective, monocentric study evaluating the efficacy of analgesia by continuous perineural catheter with Ropivacaine, in patients hospitalized for necrotizing angiodermatitis

    Summary
    EudraCT number
    		 2013-002727-42
    Trial protocol
    		 FR  
    Global end of trial date
    13 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Sep 2022
    First version publication date
    20 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RC13_0252
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01964911
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Nantes
    Sponsor organisation address
    5 allée de l'île Gloriette, Nantes, France, 44093
    Public contact
    RENAUD Sandrine, CHU de Nantes, 0033 0253482854, sandrine.renaud@chu-nantes.fr
    Scientific contact
    RENAUD Sandrine, CHU de Nantes, 0033 0253482854, sandrine.renaud@chu-nantes.fr
    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
    06 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of analgesic treatment by continuous perineural block with Ropivacaine, in patients hospitalized for necrotizing angiodermatitis.
    Protection of trial subjects
    Increased monitoring of the block and its possible complications at the patient's bedside in hospital environment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2013
    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
    France: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    1
    From 65 to 84 years
    6
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place in the Vascular Internal Medicine Department of Nantes University Hospital between 02/25/2014 and 07/13/2018. The screening was carried out by the Department physician investigators on patients needing to be hospitalized for necrotizing angiodermatitis, being hyperalgesic on entry, either an EN at rest or on dressing > 5/10.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Men or women over the age of 18 Necrotizing angiodermatitis Patients with EN collected 72 hours prior to catheter placement Hyperalgesic on admission or failure of step 1 treatment with NE ≥ 5/10, and/or NE on dressing ≥ 5/10 at home, regardless of the premedication received. OR poor tolerance of treatments

    Pre-assignment period milestones
    Number of subjects started
    		 12
    Number of subjects completed
    		 12

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Protocol treatment
    Arm description
    		 -
    Arm type
    		 Protocol treatment

    Investigational medicinal product name
    ropivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    Ropivacain 0.2% (bag of 200cc solution for injection): 5mL/h, and possibility of bolus at the time of dressing by nurse of 5 mL

    Number of subjects in period 1
    		Protocol treatment
    Started
    12
    Completed
    11
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 81.5 (68 to 92) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Primary outcome
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Only 13 patients were included out of the 30 planned but 1 didn't receive the treatment and 1 didn't have data concerning the baseline numerical pain scales. The statistical analysis is only descriptive given the small sample size (11 patients).

    Subject analysis sets values
    		 Primary outcome
    Number of subjects
    11
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    81.5 (68 to 92)
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    Protocol treatment
    Reporting group description
    		 -

    Subject analysis set title
    Primary outcome
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Only 13 patients were included out of the 30 planned but 1 didn't receive the treatment and 1 didn't have data concerning the baseline numerical pain scales. The statistical analysis is only descriptive given the small sample size (11 patients).

    Primary: Success defined by a decrease of at least 50% of one of 4 parameters related to the numerical scale of pain

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    End point title
    		 Success defined by a decrease of at least 50% of one of 4 parameters related to the numerical scale of pain [1]
    End point description
    End point type
    Primary
    End point timeframe
    Pain during the washout period (72 hours prior to treatment) was compared to pain during the first 72 hours on treatment.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis is only descriptive given the small sample size (11 patients).
    End point values
    		 Primary outcome
    Number of subjects analysed
    11
    Units: Patients
        Success
    7
        Failure
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months concerning serious adverse events and 15 days concerning adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Protocol treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Protocol treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Wound haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Faecaloma
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angiodermatitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chest wall haematoma
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscle rigidity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Protocol treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 12 (33.33%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Angiodermatitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jan 2014
    Modification concerning non-inclusion criterion related to allergies. The addition of the digital pain scale collection at 6 and 12 hours after catheter removal. Details of the examinations carried out before the start of treatment.
    23 Jun 2014
    Withdrawal of a non-inclusion criterion related to prohibited processing and modification of authorized processing accordingly. Modifications to the paragraph related to the description and justification of the therapeutic regimen.
    14 Nov 2014
    Modification of the Ropivacaine dosage (5 mL/h instead of 5 to 10 mL/h) and the duration of collection of adverse events.
    21 Mar 2016
    Change in supply management in Ropivacain and extension of the inclusion period.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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