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    Clinical Trial Results:
    Postoperative analgesia after elective hip surgery - effect of obturator nerve blockade

    Summary
    EudraCT number
    		 2017-000068-14
    Trial protocol
    		 DK  
    Global end of trial date
    08 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HIP/FUSION#2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03064165
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Thomas Fichtner Bendtsen
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 165, Aarhus N, Denmark,
    Public contact
    Niels Dalsgaard Nielsen, Elective Surgery Center, +45 22838334, nielsdn@dadlnet.dk
    Scientific contact
    Niels Dalsgaard Nielsen, Elective Surgery Center, +45 22838334, nielsdn@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
    14 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the effect of obturator nerve blockade on postoperative opioid consumption 0-12 hours after total hip replacement.
    Protection of trial subjects
    No specific measures was observed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    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: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    17
    From 65 to 84 years
    41
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 We included patients aged ≥18 years with ASA I–III status who were scheduled for primary THA in spinal anesthesia at the Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg, Denmark.

    Pre-assignment
    Screening details
    		 Assessed for eligibility, n=284; Excluded, n=222, cause of exclusion: Meeting exclusion criteria, n=154, Declined to participate, n=33, Other reasons, n=35; Randomized, n=62, thereof: Completing trial, n=60, Excluded after inclusion, n=2.

    Period 1
    Period 1 title
    Overall trial (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 nerve block
    Arm description
    		 Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine 5 mg/mL with epinephrine 5 μg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Single injection of 15 mL bupivacaine 5 mg/mL with epinephrine 5 μg/mL in the interfacial plane between the pectineus and external obturator muscles.

    Arm title
    		 Sham nerve block
    Arm description
    		 Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Single injection of 15 mL bupivacaine 5 mg/mL with epinephrine 5 μg/mL in the interfacial plane between the pectineus and external obturator muscles.

    Number of subjects in period 1
    		Active nerve block Sham nerve block
    Started
    31
    31
    Completed
    30
    30
    Not completed
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Active nerve block
    Reporting group description
    		 Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty.

    Reporting group title
    Sham nerve block
    Reporting group description
    		 Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty.

    Primary: Cumulated opioid dose (0-12 h)

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    End point title
    		 Cumulated opioid dose (0-12 h)
    End point description
    Opioid consumption was converted to Oram morphine equivalents
    End point type
    Primary
    End point timeframe
    0-12 hours after surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: milligram(s)
        arithmetic mean (standard deviation)
    39.9 ( 22.3 )
    40.5 ( 30.5 )
    Statistical analysis title
    		 Student t-test
    Comparison groups
    Sham nerve block v Active nerve block
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.93
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 13
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.9

    Secondary: Cumulated opioid dose (12-18 h)

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    End point title
    		 Cumulated opioid dose (12-18 h)
    End point description
    End point type
    Secondary
    End point timeframe
    12–18 hours after surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    12.5 (0 to 17.0)
    10.1 (0 to 17.3)
    No statistical analyses for this end point

    Secondary: Pain score at rest (1 h)

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    End point title
    		 Pain score at rest (1 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    1 hour after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Pain score at rest (2 h)

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    End point title
    		 Pain score at rest (2 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    2 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Scale
        median (inter-quartile range (Q1-Q3))
    0 (0 to 2)
    0 (0 to 2)
    No statistical analyses for this end point

    Secondary: Pain score at rest (5 h)

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    End point title
    		 Pain score at rest (5 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2.5 (2 to 3.25)
    No statistical analyses for this end point

    Secondary: Pain score at rest (7 h)

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    End point title
    		 Pain score at rest (7 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    7 hours after end-of-surgery.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    2 (1 to 3)
    No statistical analyses for this end point

    Secondary: Pain score at rest (24 h)

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    End point title
    		 Pain score at rest (24 h)
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    1 (0 to 2)
    1 (0 to 2)
    No statistical analyses for this end point

    Secondary: Pain score during passive 90° flexion of the hip (1 h)

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    End point title
    		 Pain score during passive 90° flexion of the hip (1 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    1 hour after end-of-surgery.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Pain score during passive 90° flexion of the hip (2 h)

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    End point title
    		 Pain score during passive 90° flexion of the hip (2 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    2 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 2)
    0.5 (0 to 3)
    No statistical analyses for this end point

    Secondary: Pain score during passive 90° flexion of the hip (5 h)

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    End point title
    		 Pain score during passive 90° flexion of the hip (5 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    3.5 (1 to 5)
    3 (2 to 5)
    No statistical analyses for this end point

    Secondary: Pain score during passive 90° flexion of the hip (7 h)

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    End point title
    		 Pain score during passive 90° flexion of the hip (7 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    4 (2.5 to 5)
    3 (2 to 6)
    No statistical analyses for this end point

    Secondary: Pain score during passive 90° flexion of the hip (24 h)

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    End point title
    		 Pain score during passive 90° flexion of the hip (24 h)
    End point description
    Pain evaluated by subject on numeric rating score from 0 (no pain) to 10 (worst pain imaginable)
    End point type
    Secondary
    End point timeframe
    24 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    3 (2 to 4)
    3 (1 to 5.25)
    No statistical analyses for this end point

    Secondary: Intensity of nausea (1 h)

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    End point title
    		 Intensity of nausea (1 h)
    End point description
    Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
    End point type
    Secondary
    End point timeframe
    1 hour after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Intensity of nausea (2 h)

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    End point title
    		 Intensity of nausea (2 h)
    End point description
    Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
    End point type
    Secondary
    End point timeframe
    2 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Intensity of nausea (5 h)

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    End point title
    		 Intensity of nausea (5 h)
    End point description
    Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Intensity of nausea (7 h)

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    End point title
    		 Intensity of nausea (7 h)
    End point description
    Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
    End point type
    Secondary
    End point timeframe
    7 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Intensity of nausea (24 h)

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    End point title
    		 Intensity of nausea (24 h)
    End point description
    Nausea evaluated by subject on numeric rating score from 0 (no nausea) to 10 (worst nausea imaginable)
    End point type
    Secondary
    End point timeframe
    24 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of episodes of emesis (0-18 h)

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    End point title
    		 Number of episodes of emesis (0-18 h)
    End point description
    End point type
    Secondary
    End point timeframe
    0 to 18 hours after end-of surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Number of episodes
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Cumulated dose of ondansetron (0-18 h)

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    End point title
    		 Cumulated dose of ondansetron (0-18 h)
    End point description
    End point type
    Secondary
    End point timeframe
    0 to 18 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Cumulated dose of droperidol (0-18 h)

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    End point title
    		 Cumulated dose of droperidol (0-18 h)
    End point description
    End point type
    Secondary
    End point timeframe
    0 to 18 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Time to discharge from the postanesthesia care unit (PACU)

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    End point title
    		 Time to discharge from the postanesthesia care unit (PACU)
    End point description
    End point type
    Secondary
    End point timeframe
    From end-of-surgery until discharge from PACU.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: minute
        arithmetic mean (standard deviation)
    106 ( 38 )
    123 ( 49 )
    No statistical analyses for this end point

    Secondary: Time to discharge from the hospital

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    End point title
    		 Time to discharge from the hospital
    End point description
    End point type
    Secondary
    End point timeframe
    Time from end-of-surgery to discharge from hospital.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: hour
        median (inter-quartile range (Q1-Q3))
    28 (26 to 29)
    28 (26 to 29)
    No statistical analyses for this end point

    Secondary: Duration of the spinal anesthesia

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    End point title
    		 Duration of the spinal anesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    Time from end-of-surgery until subject regains normal sensibility on anterior surface of femur.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: minute
        arithmetic mean (standard deviation)
    152 ( 38 )
    167 ( 44 )
    No statistical analyses for this end point

    Secondary: Quality of sleep

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    End point title
    		 Quality of sleep
    End point description
    Quality of sleep during the first night after surgery
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Categorical (see below)
        Sleep undisturbed
    6
    5
        Sleep disturbed but not by pain
    21
    18
        Sleep disturbed by pain
    3
    7
    No statistical analyses for this end point

    Secondary: Ability to ambulate (5 h)

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    End point title
    		 Ability to ambulate (5 h)
    End point description
    The ability to ambulate was assessed by physiotherapists using a standardized ambulation test ranging from 0 (subject was unable to ambulate to sitting position) to 8 (subject could walk with elbow crutches without personal physical support).
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    6 (4.5 to 8)
    7 (6 to 8)
    No statistical analyses for this end point

    Secondary: Muscular control of the operated leg during ambulation (5 h)

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    End point title
    		 Muscular control of the operated leg during ambulation (5 h)
    End point description
    The range of the muscular control score was 0 (subject was unable to ambulate to sitting position) to 3 (subject had good muscular control of the operated leg during all activities)
    End point type
    Secondary
    End point timeframe
    5 hours after end-of-surgery.
    End point values
    		 Active nerve block Sham nerve block
    Number of subjects analysed
    30
    30
    Units: Numeric Rating Score
        median (inter-quartile range (Q1-Q3))
    2.5 (2 to 3)
    3 (2.5 to 3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 hours after end-of-surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Active nerve block
    Reporting group description
    		 Subjects received an active obturator nerve block within 1 hour after total hip arthroplasty.

    Reporting group title
    Sham nerve block
    Reporting group description
    		 Subjects received a sham obturator nerve block (placebo) within 1 hour after total hip arthroplasty.

    Serious adverse events
    		 Active nerve block Sham nerve block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 31 (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: 5%
    Non-serious adverse events
    		 Active nerve block Sham nerve block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 31 (32.26%)
    10 / 31 (32.26%)
    Nervous system disorders
    Decreased consciousness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Vertigo / indisposition
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Fainting
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    0
    0
    Confusion postoperative
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    Blood and lymphatic system disorders
    Seepage from surgical wound
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Arterial hypotension
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    Gastrointestinal disorders
    Nausea and/or vomiting
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 31 (12.90%)
         occurrences all number
    2
    4
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Acute-in-chronic renal failure
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Endocrine disorders
    Anafylactoid reaction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0

    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/31650529
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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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