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    Clinical Trial Results:
    Determination of the minimum local anesthetic dose (MLAD) of spinal chloroprocaine for inguinal herniorrhaphy in ambulatory surgery.

    Summary
    EudraCT number
    2014-005469-58
    Trial protocol
    BE  
    Global end of trial date
    24 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jul 2020
    First version publication date
    15 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2014/007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03805503
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
    Scientific contact
    Bimetra Clinics, Ghent University Hospital, +32 93320500, Bimetra.Clinics@uzgent.be
    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
    15 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary goal of this study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
    Protection of trial subjects
    ethics review and approval, Informed Consent and monitoring
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    7
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    From the 16th September 2015 till the 7th September 2017, 12 patients participated in the study. First patient was considered as drop-out. Finally, 11 patients were included in the analysis. All participated patients were male.

    Pre-assignment
    Screening details
    • Outpatients for unilateral inguinal hernia repair • ASA I - II - III

    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
    Chloroprocainehydrochloride
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Chloroprocainehydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Chloroprocainehydrochloride 10mg/ml Chloroprocainehydrochloride 30mg/ml (rescue medication) in the epidural space A standard CSE procedure will be conducted. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.

    Number of subjects in period 1
    Chloroprocainehydrochloride
    Started
    11
    Completed
    11

    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
    11 11
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    7 7
        From 65-84 years
    4 4
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.5 ± 17.12 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    11 11
    height
    Units: cm
        arithmetic mean (standard deviation)
    179.8 ± 5.9 -
    weight
    Units: kg
        arithmetic mean (standard deviation)
    76.9 ± 10.67 -

    End points

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    End points reporting groups
    Reporting group title
    Chloroprocainehydrochloride
    Reporting group description
    -

    Primary: Minimum Local Anesthetic Dose (MLAD) of chloroprocaine 1%

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    End point title
    Minimum Local Anesthetic Dose (MLAD) of chloroprocaine 1% [1]
    End point description
    MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery. There are four crossovers visible which means that the response in two consecutive patients was four times following an opposite direction and thus successful with the possibility to lower the dose in the next patient. The mean of these doses, belonging to these crossovers is the midpoint estimator and thus the ED50 (95% CI), calculated via the original Dixon and Mood method, was 54 mg (49-54).
    End point type
    Primary
    End point timeframe
    overall study
    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: No statistical ananlyses available
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: mg
        arithmetic mean (confidence interval 95%)
    54 (49 to 54)
    No statistical analyses for this end point

    Primary: Minimum Local Anesthetic Dose (MLAD) by logistic regression

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    End point title
    Minimum Local Anesthetic Dose (MLAD) by logistic regression [2]
    End point description
    The second way to determine the ED50 (95% CI) is the logistic regression method which assumes the ED50 value of 55 mg (42-64). The sigmoid dose-response curve illustrates the intersection between a response of 50% and the curve giving the corresponding dose of the ED50.
    End point type
    Primary
    End point timeframe
    overall trial
    Notes
    [2] - 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: No statistical ananlyses available
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: mg
        log mean (confidence interval 95%)
    55 (42 to 64)
    No statistical analyses for this end point

    Primary: MLAD determined by PAVA

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    End point title
    MLAD determined by PAVA [3]
    End point description
    End point type
    Primary
    End point timeframe
    overall trial
    Notes
    [3] - 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: No statistical ananlyses available
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: mg
        arithmetic mean (confidence interval 95%)
    56 (52 to 58)
    No statistical analyses for this end point

    Secondary: time for regression of two segments

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    End point title
    time for regression of two segments
    End point description
    Time to two-segment regression varied between 15 en 55 minutes with mean value of 23 min.
    End point type
    Secondary
    End point timeframe
    overall study
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: minutes
        arithmetic mean (standard deviation)
    23 ± 13.43
    No statistical analyses for this end point

    Secondary: ambulation

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    End point title
    ambulation
    End point description
    Motor recovery lasted from 90 to 177 minutes, depending on whether only spinal or spinal along with epidural analgesia was administered. Ambulation time fluctuated between 160 and 290 minutes
    End point type
    Secondary
    End point timeframe
    overall study
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: minutes
        arithmetic mean (standard deviation)
    251.6 ± 71.28
    No statistical analyses for this end point

    Secondary: Time to micturition

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    End point title
    Time to micturition
    End point description
    The time of first voiding ranged from 164 to 390 minutes and none of the patients had urinary retention which needed a bladder catheterization.
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: minutes
        arithmetic mean (standard deviation)
    275.5 ± 70.4
    No statistical analyses for this end point

    Secondary: time of surgery

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    End point title
    time of surgery
    End point description
    End point type
    Secondary
    End point timeframe
    overall study
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: minutes
        arithmetic mean (standard deviation)
    42.4 ± 11.06
    No statistical analyses for this end point

    Secondary: motor recovery

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    End point title
    motor recovery
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: minutes
        arithmetic mean (standard deviation)
    126 ± 34.7
    No statistical analyses for this end point

    Secondary: Peak block height

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    End point title
    Peak block height
    End point description
    T1-T10
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: mg chloroprocaine 1%
        highest sensible block reached T1
    54
        lowest dermatome at T10
    56
    No statistical analyses for this end point

    Secondary: Patient satisfaction

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    End point title
    Patient satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    Chloroprocainehydrochloride
    Number of subjects analysed
    11
    Units: subjects
        satisfied
    2
        highly satisfied
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Serious adverse events
    overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 11 (81.82%)
    Cardiac disorders
    Bradycardia
    Additional description: Bradycardia (< 50 bpm) has been observed in 7 patients. One patient had a HR below 40 bpm and needed intravenous administration of the drug (i.e. Atropine 0.5 mg). This particular patient had a high sensory block reaching the level of T1 dermatome.
         subjects affected / exposed
    7 / 11 (63.64%)
         occurrences all number
    7
    Hypotension
    Additional description: The systolic blood pressure in 7 patients and in 3 patients decreased by 20% and 30% respectively the low blood pressure. Similarly, this patient has had the highest sensory block reaching the level of T1 dermatome.
         subjects affected / exposed
    7 / 11 (63.64%)
         occurrences all number
    7

    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
    24 Jan 2018
    It was decided to end the trial because the inclusion was difficult. After 3 years, only 12 patients (including 1 drop-out) were included. The number of patents choosing for a spinal anaesthesia and gives consent to participate into a trial appears to be very small.
    -

    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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