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    Clinical Trial Results:
    The effect of subpectineal obturator nerve block on opioid consumption and pain after hip arthroscopy A double-blind randomized, controlled trial

    Summary
    EudraCT number
    		 2020-001215-24
    Trial protocol
    		 DK  
    Global end of trial date
    07 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2024
    First version publication date
    08 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    7-190320
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard, Aarhus, Denmark, 8200
    Public contact
    Thomas Fichtner Bendtsen, Aarhus University Hospital, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Thomas Fichtner Bendtsen, Aarhus University Hospital, +45 51542997, tfb@dadlnet.dk
    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 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the trial is to assess the analgesic effect of preoperatively placed active or placebo subpectineal obturatorius nerve block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption
    Protection of trial subjects
    The study was approved by the Central Denmark Region Committee on Health Research Ethics (reference number 1-10-72-82-20) and the Danish Medicines Agency
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2020
    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
    Denmark: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Patients eligible for ambulatory hip arthroscopy surgery indicated by femoroacetabular impingement disease were included according to in- and exclusion criterias

    Pre-assignment
    Screening details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Patients eligible for ambulatory hip arthroscopy surgery indicated by femoroacetabular impingement disease were included according to in- and exclusion criterias

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active SOB
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine 5 mg/ mL+Epinephrine 5 μg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    15 ml Bupivacaine 5 mg/ mL+Epinephrine 5 μg/mL

    Arm title
    		 Placebo SOB
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline 9 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    15 mL saline 9 mg/ml

    Number of subjects in period 1
    		Active SOB Placebo SOB
    Started
    20
    20
    Completed
    0
    0
    Not completed
    20
    20
         Protocol deviation
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active SOB
    Reporting group description
    		 -

    Reporting group title
    Placebo SOB
    Reporting group description
    		 -

    Reporting group values
    		 Active SOB Placebo SOB Total
    Number of subjects
    		 20 20 40
    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)
    		 20 20 40
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 9 20
        Male
    		 9 11 20

    End points

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    End points reporting groups
    Reporting group title
    Active SOB
    Reporting group description
    		 -

    Reporting group title
    Placebo SOB
    Reporting group description
    		 -

    Primary: IV morphine equivalent consumption

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    End point title
    		 IV morphine equivalent consumption
    End point description
    End point type
    Primary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    20 [1]
    20 [2]
    Units: milligram(s)
        arithmetic mean (standard deviation)
    0 ( 0 )
    0 ( 0 )
    Notes
    [1] - All test subjects excluded due to protocol deviation
    [2] - All test subjects excluded due to protocol deviation
    Statistical analysis title
    		 Unpaired t test
    Comparison groups
    Active SOB v Placebo SOB
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0 [4]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - All test subjects excluded due to protocol deviation
    [4] - All test subjects excluded due to protocol deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From anesthesia until discharge from the ambulatory surgery department
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Active SOB group
    Reporting group description
    		 -

    Reporting group title
    Placebo SOB group
    Reporting group description
    		 -

    Serious adverse events
    		 Active SOB group Placebo SOB group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active SOB group Placebo SOB group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The were no adverse events reported in this trial, neither serious nor non-serious. The Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals monitored the trial and confirmed this. Due to protocol deviation all test subjects were excluded. No statistics made. No publication of the study.

    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
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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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