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    Clinical Trial Results:
    The Efficacy of Continuous Intra-articular Infusion of Local Anaesthetic Agent following Elective Primary Hip Arthroplasty

    Summary
    EudraCT number
    2011-001510-33
    Trial protocol
    GB  
    Global end of trial date
    26 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Dec 2020
    First version publication date
    17 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RR11/9781
    Additional study identifiers
    ISRCTN number
    ISRCTN24271997
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Leeds Teaching Hospitals NHS Trust
    Sponsor organisation address
    Beckett Street , Leeds, United Kingdom, LS9 7TF
    Public contact
    Dr Martin Stone , Leeds Teaching Hospitals NHS Trust , martin.stone@nhs.net
    Scientific contact
    Dr Martin Stone , Leeds Teaching Hospitals NHS Trust , martin.stone@nhs.net
    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
    26 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine whether the use of a continuous intra-articular infusion of local anaesthetic might reduce the need for post-operative opiate use in patients undergoing hip replacement.
    Protection of trial subjects
    This clinical trial, which involves the use of an investigational medicinal product has been designed and will be run in accordance with the Principles of GCP and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004 / 1031) and any subsequent amendments of the clinical trial regulations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 May 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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients attending for unilateral, elective primary hip arthroplasty will be randomised into one of two groups, Treatment, and Control. :A verbal explanation of the trial and Patient Information Leaflet (PIL) will be provided by the authorised trial clinician for the patient to consider.

    Pre-assignment
    Screening details
    It is essential that patients greater than 70 years old are recruited to the study. Many patients presenting for primary hip arthroplasty are in this age group and it is anticipated that reduced post operative morphine consumption in these patients will be of particular benefit.

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor
    Blinding implementation details
    The ODP will complete a tick-box form on carbon paper which records the contents of the pain pump and the medicinal product batch numbers. The top copy will bear a patient information sticker and the other copy will have only the study reference number and no patient identifiable information. The top copy of the form is placed in a sealed, opaque envelope which is stapled to the inside of the patient’s notes. The other copy is placed in a sealed, opaque envelope and put into a secure storage

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment
    Arm description
    Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 hours.
    Arm type
    Experimental

    Investigational medicinal product name
    bupivacaine local anaesthetic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bupivacaine hydrochloride is presented as a clear, colourless solution for injection in a range of concentrations. The 2.5mg/ml concentration is used in the LIA study. Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 h.

    Arm title
    Placebo
    Arm description
    Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h.

    Number of subjects in period 1
    Treatment Placebo
    Started
    99998
    1
    Completed
    99998
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial Period
    Reporting group description
    -

    Reporting group values
    Main Trial Period Total
    Number of subjects
    99999 99999
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    99999 99999
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    99999 99999

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of bupivacaine local anaesthetic over the following 48 hours.

    Reporting group title
    Placebo
    Reporting group description
    Patients in this group will receive a one-off bolus of local anaesthetic mixture followed by an infusion of saline placebo over the following 48 h.

    Primary: 30% reduction in the amount of opiate analgesia required by patients 48 hour post-operative period

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    End point title
    30% reduction in the amount of opiate analgesia required by patients 48 hour post-operative period [1]
    End point description
    A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.
    End point type
    Primary
    End point timeframe
    The primary endpoint is a 30% reduction in the amount of opiate analgesia required by patients in the 48 hour post-operative period in the treatment group compared to the placebo group.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.
    End point values
    Treatment Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: participants
    Notes
    [2] - data analysis is incomplete for this trial.
    [3] - data analysis is incomplete for this trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs will be collected for all patients and will be evaluated for duration and intensity according to the NCRI Common Toxicity Criteria.
    Adverse event reporting additional description
    AEs will be collected for all patients from first dose of protocol treatment until 30 days after the last dose of treatment with a protocol IMP. Information about AEs, whether volunteered by the patient, discovered by the investigator questioning or detected through physical examination, laboratory test or other investigation will be collected
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.0
    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: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2015
    The trial had multiple substantial amendments, but a full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.

    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.
    A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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