Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Chloroprocainehydrochloride
    Reporting group description
    		 -

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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page
    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

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 08 18:02:26 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA