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    Clinical Trial Results:
    Effect of a lateral nerve of the thigh block on postoperative pain after total hip replacement surgery: a clinical radomised trial.

    Summary
    EudraCT number
    		 2013-004501-12
    Trial protocol
    		 DK  
    Global end of trial date
    01 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2017
    First version publication date
    16 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    001-2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02289937
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Departement of Anesthesiology, Næstved Hospital
    Sponsor organisation address
    Ringstedgade 61, Næstved, Denmark, 4700
    Public contact
    Daniel Hägi-Pedersen, Departement of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.dk
    Scientific contact
    Daniel Hägi-Pedersen, Departement of Anesthesiology, Næstved Hospital, +45 56514792, dhag@regionsjaelland.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
    20 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigation of the influence of a lateral cutaneus nerve of the thigh block on postoperative pain after total hip replacement surgery with visual analog scale and on the total oxynorm dose 1. day after surgery.
    Protection of trial subjects
    Treated with usual care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2014
    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
    Denmark: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    25
    From 65 to 84 years
    71
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients planned for primary total hip replacement

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ropivacaine
    Arm description
    		 8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    Other name
    naropin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    60 milligrams

    Arm title
    		 Placebo
    Arm description
    		 8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    8 milliliters

    Number of subjects in period 1
    		Ropivacaine Placebo
    Started
    47
    53
    Completed
    47
    53

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Ropivacaine
    Reporting group description
    		 8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.

    Reporting group title
    Placebo
    Reporting group description
    		 8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided

    Primary: VAS-score 4 hours postoperative during movement

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    End point title
    		 VAS-score 4 hours postoperative during movement
    End point description
    End point type
    Primary
    End point timeframe
    4 hours postoperative
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    47
    53
    Units: mm
        median (inter-quartile range (Q1-Q3))
    26.5 (13.5 to 40)
    31 (18 to 50)
    Statistical analysis title
    		 Mann-Withney-U-Test
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Oxycodone consumed the first 24 h

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    End point title
    		 Oxycodone consumed the first 24 h
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    47
    53
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    7 (2 to 13)
    6 (2 to 9)
    No statistical analyses for this end point

    Secondary: Time to first oxynorm requirement

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    End point title
    		 Time to first oxynorm requirement
    End point description
    End point type
    Secondary
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    47
    53
    Units: minute
        median (inter-quartile range (Q1-Q3))
    253 (144 to 379)
    237 (155 to 380)
    No statistical analyses for this end point

    Secondary: Cumulated ambulation score the first day

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    End point title
    		 Cumulated ambulation score the first day
    End point description
    Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
    End point type
    Secondary
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    33
    43
    Units: score
        median (inter-quartile range (Q1-Q3))
    5 (3 to 6)
    5 (4 to 6)
    No statistical analyses for this end point

    Secondary: Time from surgery to first ambulation

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    End point title
    		 Time from surgery to first ambulation
    End point description
    Time to first mobilization
    End point type
    Secondary
    End point timeframe
    0-24 hours postoperatively
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    47
    53
    Units: minute
        median (inter-quartile range (Q1-Q3))
    368 (330 to 519)
    420 (364 to 470)
    No statistical analyses for this end point

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    0-7 days postoperative
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    47
    53
    Units: hour
        arithmetic mean (standard deviation)
    49 ± 10
    50 ± 20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    0-24 hours postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICH Guideline
    Dictionary version
    E6
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Only adverse events related to the study medication were included.

    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/27006014
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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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