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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
    		 2021-006575-42
    Trial protocol
    		 DK  
    Global end of trial date
    31 Oct 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    03_14042023
    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
    27 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the trial is to asses the analgesic effect of preoperatively placed active or placebo subpectineal obturator 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 1-10-72-374-21) and the Danish Medicines Agency
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2022
    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
    		 Active subpectineal obturator nerve block
    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/infusion 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
    		 Placebo subpectineal obturator nerve block
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline 9 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection 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
    18
    16
    Not completed
    2
    4
         Lost to follow-up
    1
    -
         Protocol deviation
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active SOB
    Reporting group description
    		 Active subpectineal obturator nerve block

    Reporting group title
    Placebo SOB
    Reporting group description
    		 Placebo subpectineal obturator nerve block

    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
    		 16 12 28
        Male
    		 4 8 12

    End points

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    End points reporting groups
    Reporting group title
    Active SOB
    Reporting group description
    		 Active subpectineal obturator nerve block

    Reporting group title
    Placebo SOB
    Reporting group description
    		 Placebo subpectineal obturator nerve block

    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
    18
    16
    Units: mg
        arithmetic mean (standard deviation)
    11.9 ( 5.8 )
    19.7 ( 6.7 )
    Statistical analysis title
    		 Unpaired t test
    Comparison groups
    Active SOB v Placebo SOB
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Numeric Rating Scale (NRS) pain score

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    End point title
    		 Numeric Rating Scale (NRS) pain score
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: nrs
        median (inter-quartile range (Q1-Q3))
    4.5 (3 to 5)
    5 (3.5 to 6)
    No statistical analyses for this end point

    Secondary: Adductor strength

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    End point title
    		 Adductor strength
    End point description
    End point type
    Secondary
    End point timeframe
    Before nerveblock (time 0) and after 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: percent
        arithmetic mean (standard deviation)
    80 ( 0.13 )
    38 ( 0.23 )
    No statistical analyses for this end point

    Secondary: Intraoperative hip traction time

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    End point title
    		 Intraoperative hip traction time
    End point description
    End point type
    Secondary
    End point timeframe
    Time traction was applied until the termination of hip traction
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: minute
        arithmetic mean (standard deviation)
    25 ( 7 )
    22 ( 4 )
    No statistical analyses for this end point

    Secondary: Intraoperative consumption of propofol

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    End point title
    		 Intraoperative consumption of propofol
    End point description
    End point type
    Secondary
    End point timeframe
    During anesthesia
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: milligram(s)
        arithmetic mean (standard deviation)
    522 ( 188 )
    532 ( 122 )
    No statistical analyses for this end point

    Secondary: Intraoperative consumption of Remifentanil

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    End point title
    		 Intraoperative consumption of Remifentanil
    End point description
    End point type
    Secondary
    End point timeframe
    During anesthesia
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: milligram(s)
        arithmetic mean (standard deviation)
    2.16 ( 0.68 )
    2.11 ( 0.64 )
    No statistical analyses for this end point

    Secondary: Length of stay in the PACU

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    End point title
    		 Length of stay in the PACU
    End point description
    End point type
    Secondary
    End point timeframe
    The time in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: minute
        arithmetic mean (inter-quartile range (Q1-Q3))
    180 (165 to 268)
    205 (185 to 223)
    No statistical analyses for this end point

    Secondary: Duration of anesthesia

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    End point title
    		 Duration of anesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    Induction of anesthesia until removal of the laryngeal mask
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: minute
        arithmetic mean (standard deviation)
    72 ( 13 )
    69 ( 12 )
    No statistical analyses for this end point

    Secondary: Frequency of vomiting

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    End point title
    		 Frequency of vomiting
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: number
    0
    0
    No statistical analyses for this end point

    Secondary: Postoperative PONV score

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    End point title
    		 Postoperative PONV score
    End point description
    End point type
    Secondary
    End point timeframe
    Maximun PONV score the first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: ponv
    number (not applicable)
        None
    18
    16
        Mild
    0
    0
        Moderate
    0
    0
        Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Patient satisfaction (NRS 0–10)

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    End point title
    		 Patient satisfaction (NRS 0–10)
    End point description
    End point type
    Secondary
    End point timeframe
    Patient satisfaction (NRS 0–10)
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: nrs
        median (inter-quartile range (Q1-Q3))
    10 (9 to 10)
    9 (8 to 10)
    No statistical analyses for this end point

    Secondary: Droperidol

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    End point title
    		 Droperidol
    End point description
    End point type
    Secondary
    End point timeframe
    Droperidol consumption the first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: milligram(s)
    number (not applicable)
        0 mg
    18
    16
        0.625 mg
    0
    0
    No statistical analyses for this end point

    Secondary: Ondansetron

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    End point title
    		 Ondansetron
    End point description
    End point type
    Secondary
    End point timeframe
    Ondansetron consumption the first 3 hours in the PACU
    End point values
    		 Active SOB Placebo SOB
    Number of subjects analysed
    18
    16
    Units: mg
    number (not applicable)
        0 mg
    18
    16
        2 mg
    0
    0
        4 mg
    0
    0
    No statistical analyses for this end point

    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 / 18 (0.00%)
    0 / 16 (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: 0%
    Non-serious adverse events
    		 Active SOB group Placebo SOB group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 16 (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.

    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/38925710
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