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    Clinical Trial Results:
    Does the use of the ropicaine facilitate laparoscopic cholecystectomy in ambulatory surgery?

    Summary
    EudraCT number
    		 2013-005109-30
    Trial protocol
    		 FR  
    Global end of trial date
    05 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHD079-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02085902
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Hospitalier Départemental Vendée
    Sponsor organisation address
    Bd Stéphane Moreau, La roche sur yon, France, 85000
    Public contact
    MARTIN Stéphanie , Centre Hospitalier Départemental Vendée, +33 0251446483, stephanie.martin@chd-vendee.fr
    Scientific contact
    MARTIN Stéphanie , Centre Hospitalier Départemental Vendée, +33 0251446483, stephanie.martin@chd-vendee.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
    07 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to increase by 24,4 % the number of outpatient laparoscopic cholecystectomy
    Protection of trial subjects
    Patient have to sign an informed consent.
    Background therapy
    		 All patients had general anesthesia . The per-operative anesthesia protocol was as follows: • _ During induction, propofol, remifentanil and atracurium0.5 mg/kg. • _ Liquid intake of 1000 ml • _ Before incision ketamine 0.15 mg/kg • _ Analgesic 30–45 min before the end of surgery:paracetamol 15 mg/kg, ketoprofen 1 mg/Kg, morphine100 lg/kg, nefopam 20 mg in the absence of contraindications. Postoperative analgesia was as follows: • _ paracetamol 1 g 9 4/days • _ Ketoprofen 100 mg 1 cp 9 2/days • _ Oxycodone 5 mg every 4–6 h if needed (step 3) •_ Ondansetron 4 mg if postoperative nausea or vomiting. If necessary some step 2 medications could be used such as nefopam, tramadol.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2014
    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: 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
    		 First inclusion:24/03/2014 Last inclusion:31/03/2015 124 patients were screened for inclusion 122 patient signed an informed consent 102 patient were randomised but 2 have withdrawn their consent before cholecystectomy (no data collection for these 2 patients) 100 patients were analysed One Study site : CHD Vendée La Roche sur YON, France

    Pre-assignment
    Screening details
    		 124 patients were screened for inclusion

    Period 1
    Period 1 title
    période de traitement (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Ropivacaine is started during the open surgery (depending on the randomization arm), and then the pain will be collected in a second time by a nurse or a surgeon in a blinded fashion at H2, H6, D1, The evaluation of the primary endpoint will be done in a blinded fashion by a nurse or a surgeon different from the one who performed the procedure. Translated with www.DeepL.com/Translator (free vers

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard anesthesia
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Standard anesthesia with ropivacaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    150 mg (7,5 mg/ml : 20 ml diluted in 40 mL of saline

    Number of subjects in period 1
    		Standard anesthesia Standard anesthesia with ropivacaine
    Started
    50
    50
    H2
    50
    50
    H6
    50
    50
    J1
    50
    50
    J0 = cholecystectomy
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard anesthesia
    Reporting group description
    		 -

    Reporting group title
    Standard anesthesia with ropivacaine
    Reporting group description
    		 -

    Reporting group values
    		 Standard anesthesia Standard anesthesia with ropivacaine Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 50 50 100
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Not recorded
    		 0 0 0
    Age continuous
    Age (year)
    Units: years
        arithmetic mean (standard deviation)
    		 45.7 ( 13.4 ) 49.9 ( 15.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 34 69
        Male
    		 15 16 31
    Operative Cholangiography
    Units: Subjects
        Operative Cholangiography
    		 48 47 95
        Not recorded
    		 2 3 5
    Temperature
    Units: °C
        arithmetic mean (standard deviation)
    		 36.7 ( 0.4 ) 36.9 ( 0.5 ) -
    Cardiac frequency
    Units: bpm
        arithmetic mean (standard deviation)
    		 77 ( 13.1 ) 79.4 ( 14.2 ) -
    Systolic arterial pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 127.3 ( 17.8 ) 127.5 ( 17.1 ) -
    Diastolic arterial pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76.4 ( 10 ) 76.7 ( 9.5 ) -
    respiratory frequency
    Units: /min
        arithmetic mean (standard deviation)
    		 18.5 ( 9.7 ) 17.3 ( 3.1 ) -
    Lengh of surgery
    Units: minute
        arithmetic mean (standard deviation)
    		 57.2 ( 16 ) 56.1 ( 11.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    Standard anesthesia
    Reporting group description
    		 -

    Reporting group title
    Standard anesthesia with ropivacaine
    Reporting group description
    		 -

    Primary: Effective hospital discharge of patient

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    End point title
    		 Effective hospital discharge of patient
    End point description
    Six hours after surgery, the patient was evaluated to authorize home discharge. For this evaluation, the Chung score for discharge was used . Discharge was authorized with a score equal to or above 9. However, depending on the situation, it is possible that a patient with a Chung score higher than 9 may require prolonged hospitalization, which is why : Will be considered "successful": all patients for whom a discharge decision has been made at H6 with an effective discharge, whatever the Chung score obtained. Will be considered a "failure": all patients requiring an extension of their stay in a traditional digestive surgery hospital (or other service) after H6, whatever the Chung score obtained.
    End point type
    Primary
    End point timeframe
    H6
    End point values
    		 Standard anesthesia Standard anesthesia with ropivacaine
    Number of subjects analysed
    50
    50
    Units: number of patient
        Effective hospital discharge
    49
    49
    Statistical analysis title
    		 Effective hospital discharge of patient
    Comparison groups
    Standard anesthesia v Standard anesthesia with ropivacaine
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Primary: Chung Score < 9

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    End point title
    		 Chung Score < 9
    End point description
    End point type
    Primary
    End point timeframe
    H6
    End point values
    		 Standard anesthesia Standard anesthesia with ropivacaine
    Number of subjects analysed
    50
    50
    Units: Number of patient
        Chun Score <9
    2
    2
    Statistical analysis title
    		 Chung score
    Comparison groups
    Standard anesthesia v Standard anesthesia with ropivacaine
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation (intervention) until end of participation of patient (J1)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Standard Anesthesia
    Reporting group description
    		 -

    Reporting group title
    Standard anesthesia with ropivacine
    Reporting group description
    		 -

    Serious adverse events
    		 Standard Anesthesia Standard anesthesia with ropivacine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Standard Anesthesia Standard anesthesia with ropivacine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 50 (52.00%)
    26 / 50 (52.00%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    9 / 50 (18.00%)
    8 / 50 (16.00%)
         occurrences all number
    9
    9
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 50 (26.00%)
    17 / 50 (34.00%)
         occurrences all number
    13
    17
    Nausea
         subjects affected / exposed
    6 / 50 (12.00%)
    5 / 50 (10.00%)
         occurrences all number
    6
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2014
    The following inclusion criteria was deleted : patient living at less than 50 Km from CHd Vendee
    03 Feb 2015
    Increase of study duration Increase of number of patient to be included (from 100 to 120) because of the number of screen failure and in order to reach 90 analyzable patients

    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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