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    Clinical Trial Results:
    The FINOF(Femoral Nerve-Block Intervention in Neck Of Femur Fracture) Study

    Summary
    EudraCT number
    2010-023871-25
    Trial protocol
    GB  
    Global end of trial date
    05 Jan 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions
    Summary report(s)
    End of Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-023871-25
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Nottingham University Hospitals NHS Trust
    Sponsor organisation address
    Derby Road, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Maria Koufali, Nottingham Univeristy Hospitals NHS Trust, researchsponsor@nuh.nhs.uk
    Scientific contact
    Maria Koufali, Nottingham Univeristy Hospitals NHS Trust, researchsponsor@nuh.nhs.uk
    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
    05 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The question to be asked is whether femoral nerve blockade, administered in the acute and early post operative phase to elderly hip fracture patients, will control pain,improve early rehabilitation and reduce opioid associated complications.
    Protection of trial subjects
    The study received ethical approval on 28/Jan/2011 from Nottingham Research Ethics Committee 2 and by the MHRA on 21/Apr/2011. To facilitate rapid analgesia patients were consented as a two stage procedure. Patients were provided with the patient information sheet and the study was discussed. Initial verbal consent was obtained in the ED by the attending anaesthetist. This was witnessed by a member of the research team and documented. Full written consent was obtained 48 hours after verbal consent or as close as this as possible. Patients who developed confusion after study entry and were unable to give written cosnent had proxy consent sought from the lsited next of kin or contact person. If no primary contact person could be found the orthopaedic consultant in charge of the patients care was approached. Once patients had regained capacity, formal written consent was sought as per usual study procedure. Participants were monitored for AEs and SAEs and these were reported as per the sponsor SOP.
    Background therapy
    In addition to the IMP (Femoral Nerve block) the active group received regular paracetamol with oral morphine for breakthrough analgesia. They also had a femoral nerve catheter which infused 5mls/hr of 0.2% ropivacaine via an elastomeric pump. In addition to the control treatment, the control group received regular paracetamol and regular tramadol with oral morphine solution every 2 hours as required for breakthrough pain.
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jan 2012
    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
    United Kingdom: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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
    60
    85 years and over
    51

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment started on 6th Jan 2011 and the last participant was screened on 1st Dec 2014

    Pre-assignment
    Screening details
    Patients presenting with history suggestive of proximal femoral fracture were attended and inclusion/exclusion criteria were checked. If patients were eligible then initial verbal consent was obtained.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Femoral Nerve Block
    Arm description
    Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block
    Arm type
    Experimental

    Investigational medicinal product name
    Levo-bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    0.5 ml/kg-1 of 0.25% levobupivacaine up to 30 ml maximum volume

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    5ml/hr 0.2% ropivacaine for up to 48 hours post-operatively

    Arm title
    Control
    Arm description
    Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below.
    Arm type
    Active comparator

    Investigational medicinal product name
    Morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below.

    Number of subjects in period 1
    Femoral Nerve Block Control
    Started
    55
    56
    Post op- Follow Up
    55
    56
    Completed
    55
    56

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Femoral Nerve Block
    Reporting group description
    Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block

    Reporting group title
    Control
    Reporting group description
    Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below.

    Reporting group values
    Femoral Nerve Block Control Total
    Number of subjects
    55 56 111
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    83 (73 to 93) 84 (71 to 97) -
    Gender categorical
    Units: Subjects
        Female
    45 44 89
        Male
    10 12 22
    Body Mass Index
    Units: kg/m2
        arithmetic mean (full range (min-max))
    23.1 (14 to 35) 23.9 (16 to 32) -
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Full primary outcome data was collected on a total of 111 patients (55 active, 56 control).

    Subject analysis sets values
    Per protocol
    Number of subjects
    111
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    89
        Male
    22
    Body Mass Index
    Units: kg/m2
        arithmetic mean (full range (min-max))
    (14 to 35)

    End points

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    End points reporting groups
    Reporting group title
    Femoral Nerve Block
    Reporting group description
    Femoral nerve block followed by insertion of a femoral catheter and continuous femoral nerve block

    Reporting group title
    Control
    Reporting group description
    Standard analgesic care - intravenous morphine titrated to a score of 5 or less at rest according to the 10 point numerical pain rating scale described below.

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Full primary outcome data was collected on a total of 111 patients (55 active, 56 control).

    Primary: Cumulative Ambulation Score

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    End point title
    Cumulative Ambulation Score
    End point description
    End point type
    Primary
    End point timeframe
    Three days, post-operative
    End point values
    Femoral Nerve Block Control
    Number of subjects analysed
    55
    56
    Units: Score
    7
    6
    Statistical analysis title
    p-value
    Comparison groups
    Femoral Nerve Block v Control
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.76
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Cumulative Dynamic pain score

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    End point title
    Cumulative Dynamic pain score
    End point description
    End point type
    Primary
    End point timeframe
    three days post-operative
    End point values
    Femoral Nerve Block Control
    Number of subjects analysed
    55
    56
    Units: score
    20
    20
    Statistical analysis title
    p-value
    Comparison groups
    Femoral Nerve Block v Control
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.505
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs occurring during the study observed by the investigator or reported by the participant, whether or not attributed to study medication, will be recorded on the CRF.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    -

    Reporting group title
    Active
    Reporting group description
    -

    Serious adverse events
    Control Active
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 56 (25.00%)
    9 / 55 (16.36%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    stroke
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ disorder
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fat embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chest infection
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Control Active
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 56 (64.29%)
    30 / 55 (54.55%)
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 56 (53.57%)
    25 / 55 (45.45%)
         occurrences all number
    30
    25
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 56 (10.71%)
    5 / 55 (9.09%)
         occurrences all number
    6
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 May 2011
    1) Use of pump changed to continue for 48 hours after operation 2) Additional block assessments to be performed at 60 min and 180 min post operatively 3) Dynamic pain assessments clarified; to be performed at 30 min, 60 min and 180 min post block 4) Clarification that a continuous infusion of local anaesthetic will be given for 48 hours post operatively
    21 Dec 2011
    The type of pump changed from Accufusor to Elastomeric to allow generic pumps.
    27 Sep 2013
    1) Follow up duration amended to 30(±5) days to give more flexibility 2) Clarification that cumulative dynamic pain scores are performed preoperatively (at 30 mins, 180 mins and following the initial femoral nerve block) 3) Changed to state that daily calorific intake and bowels (frequency and type) are not collected at pre-op 4) Assessment of nausea and vomiting clarified to ensure it matches the actual data collected and scoring system used in the CRF 5) Other typographical changes and changes to timelines. 6) Clarification of duration of catheter insertion and use of Oramorph which is standard practice on wards.

    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.
    Not all data was available to the results uploader so although 141 participants were enrolled, data from withdrawn patients has not been included in the database, therefore some information has been omitted for validation purposes.
    For support, Contact us.
    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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