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    Clinical Trial Results:
    Effectiveness of Added blocking of radial and median nerves with levobupivacaine in the control of postoperative pain in the rhizarthrosis ambulatory surgery

    Summary
    EudraCT number
    		 2011-001340-29
    Trial protocol
    		 ES  
    Global end of trial date
    03 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2021
    First version publication date
    23 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IIBSP-LEV-2011-21
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01597479
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
    Sponsor organisation address
    Sant Quintí 77-79, Barcelona, Spain, 08041
    Public contact
    UICEC Sant Pau, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, 34 935537636, uicec@santpau.cat
    Scientific contact
    UICEC Sant Pau, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau, 34 935537636, uicec@santpau.cat
    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
    21 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the efficacy of peripheral block of the radial and median nerves to control pain after outpatient surgery for rhizarthrosis at the time of maximum intensity, that is, in the first 24-48 hours.
    Protection of trial subjects
    This trial was conducted in compliance with the principles laid down the Declaration of Helsinki and all applicable EU and national laws. In addition, it adheres to the principles expressed in ICH-GCP (International Conference on Harmonization - Good Clinical Practice) and the requirements of the EU and National Data Protection Regulation. Study protocol including consent documents were approved in advance by the leading Ethic Committee, by competent authorities and any other regulatory bodies (as specified by national regulations). Participants in the clinical trial were adequately informed prior to their inclusion. In particular, all patients were informed about the voluntary nature of his/her participation, confidentiality and protection of his/her data, potential risks and benefits of participation, insurance coverage and the possibility of withdrawal at any time. The principle of patient autonomy was clearly enforced. Freely given informed consent was obtained from and documented in writing, signed and dated personally by each patient (or by an individual or juridical or other body authorized under applicable law to consent on behalf of a prospective subject) before he/she is inclusion in any study or project. The protection of human subjects is also promoted by adequate monitoring of drug/treatment safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2010
    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
    Spain: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    0
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We enrolled consecutive adult ASA I-III patients undergoing elective ambulatory trapeziectomy from February 2012 to april 2014.

    Pre-assignment
    Screening details
    		 -Men or women over 18 years of age. -Outpatient surgery for rhizarthrosis. -Free acceptance to participate in the study, with consent informed signed by the patient, guardian or responsible family member.

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

    Period 1
    Period 1 title
    Visit 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM H
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ARM R
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levobupivacaína
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    Infiltration and nerve block with 5 mL 0.125% levobupivacaine

    Number of subjects in period 1
    		ARM H ARM R
    Started
    26
    26
    Completed
    26
    26
    Period 2
    Period 2 title
    Visit 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM H
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ARM R
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levobupivacaína
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    Infiltration and nerve block with 5 mL 0.125% levobupivacaine

    Number of subjects in period 2
    		ARM H ARM R
    Started
    26
    26
    Completed
    26
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ARM H
    Reporting group description
    		 -

    Reporting group title
    ARM R
    Reporting group description
    		 -

    Reporting group values
    		 ARM H ARM R Total
    Number of subjects
    		 26 26 52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 26 26 52
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13 26
        Male
    		 13 13 26

    End points

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    End points reporting groups
    Reporting group title
    ARM H
    Reporting group description
    		 -

    Reporting group title
    ARM R
    Reporting group description
    		 -
    Reporting group title
    ARM H
    Reporting group description
    		 -

    Reporting group title
    ARM R
    Reporting group description
    		 -

    Primary: Pain intensity at 24 and 48 hours after trapeziectomy

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    End point title
    		 Pain intensity at 24 and 48 hours after trapeziectomy
    End point description
    End point type
    Primary
    End point timeframe
    24 and 48 post trapeziectomy
    End point values
    		 ARM H ARM R ARM H ARM R
    Number of subjects analysed
    26
    26
    26
    26
    Units: 1-10
        number (not applicable)
    26
    26
    26
    26
    Statistical analysis title
    		 x2
    Comparison groups
    ARM H v ARM R v ARM H v ARM R
    Number of subjects included in analysis
    104
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 10
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    ARM H
    Reporting group description
    		 Received an axillary brachial plexus block before surgery

    Reporting group title
    ARM R
    Reporting group description
    		 Patients received an axillary brachial plexus block before surgery. In the postanesthesia care unit , patients in this group received a concomitant block of the median and radial nerves at the elbow

    Serious adverse events
    		 ARM H ARM R
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ARM H ARM R
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 26 (3.85%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1

    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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29405670
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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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