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    Clinical Trial Results:
    A dose finding study for ultrasound guided anterior psoas compartment blocks in patients with a fractured neck of femur

    Summary
    EudraCT number
    2009-013462-25
    Trial protocol
    GB  
    Global end of trial date
    04 Apr 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Apr 2019
    First version publication date
    04 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GN09AN334
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00926666
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde Health Board
    Sponsor organisation address
    Dalnair Street, Glasgow, United Kingdom, G3 8SJ
    Public contact
    Dr Malcolm Watson, NHS Greater Glasgow and Clyde, 0044 141 452 3430, Malcolm.Watson@ggc.scot.nhs.uk
    Scientific contact
    Dr Malcolm Watson, NHS Greater Glasgow and Clyde, 0044 141 452 3430, Malcolm.Watson@ggc.scot.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
    04 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Can we reduce the dose of local anaesthetic required to provide pain relief to patients with a broken hip by determining the dose based on the amount of the drug required to relieve pain?
    Protection of trial subjects
    All patient recruited to this study received standard analgesia and anaesthesia for a emergency hip arthroplasty or fixation. The only variable was the concentration of local anaesthetic used to provide an anterior psoas compartment block. All peripheral nerve blocks have an associated risk. The commonest complication was peripheral neuropathy and the vast majority of these neuropathies were not present after 6 months. The sighting of an anterior psoas compartment block (femoral nerve block) is considered to have an acceptable risk benefit ratio for elective and emergency hip and knee arthroplasty in current clinical practice.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 2010
    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: 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)
    0
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    40 patients recruited from 1st Feb 2010 to 17th Nov 2010 Patients with a traumatic proximal femoral fracture scheduled for surgical hip fixation were recruited.

    Pre-assignment
    Screening details
    Potential recruits to the study were identified by the nursing and medical staff of the orthopaedic trauma ward.

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

    Arms
    Arm title
    Arm A and B
    Arm description
    Part A - A single 30ml dose of levobupivacaine with the dose concentration increased following an unsuccessful anterior psoas compartment block and decreased following an effective anterior psoas compartment block. Part B - To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits.
    Arm type
    Experimental

    Investigational medicinal product name
    levobupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Part A - The first 16 patients were treated with a starting concentration of 0.1% and the concentration was decreased or increased by 0.025% depending on whether the previous dose was effective or not. In part B the dose will be the same for all patients (calculated from the results of part A).

    Number of subjects in period 1
    Arm A and B
    Started
    40
    Completed
    36
    Not completed
    4
         Physician decision
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A and B
    Reporting group description
    Part A - A single 30ml dose of levobupivacaine with the dose concentration increased following an unsuccessful anterior psoas compartment block and decreased following an effective anterior psoas compartment block. Part B - To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits.

    Primary: Part A - Primary Outcome

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    End point title
    Part A - Primary Outcome [1]
    End point description
    EC50 and EC95 concentrations of 30mls of levobupivacaine for ≥10hours of analgesia after a femoral 3-in-1 nerve block.
    End point type
    Primary
    End point timeframe
    From 3 in 1 nerve block administration to 24 hours post
    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: Details of the statistical analysis performed are within CIs PhD published. Results uploader not involved in study at all.
    End point values
    Arm A and B
    Number of subjects analysed
    36
    Units: EC50 and EC95
        number (not applicable)
    36
    Attachments
    Part A Primary Endpoint
    No statistical analyses for this end point

    Primary: Part B - Primary Outcome

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    End point title
    Part B - Primary Outcome [2]
    End point description
    To estimate the duration of analgesia provided by the EC95 concentration of levobupivacaine estimated (using probit logistic regression analysis) to provide ≥10 hours of analgesia from part A of this clinical trial and to determine if the peak plasma levobupivacaine concentrations are within safe limits.
    End point type
    Primary
    End point timeframe
    Nerve block administration to 24 hours
    Notes
    [2] - 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: Details of the statistical analysis performed are within CIs PhD published. Results uploader not involved in study at all.
    End point values
    Arm A and B
    Number of subjects analysed
    36
    Units: Pain Score
        number (not applicable)
    14
    Attachments
    Part B - Primary Endpoint
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    A - From discharge from theatre, events were only reported and recorded if they are causally related to the anterior psoas compartment nerve block. B - Adverse events occurring after the final pain scores are recorded (up to 24 hours later).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Serious Adverse Events
    Reporting group description
    -

    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: These were not collected
    Serious adverse events
    Serious Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death from Breast cancer and comorbitities
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Serious Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Aug 2010
    1 prolongation of the maximum storage period of the IMP between preparation (by the pharmacy production unit) and patient administration, 2 the insertion of a catheter after injection of the IMP to allow continued pain relief, 3 a broadening of the inclusion criteria to include patients with proximal femoral fractures who will be managed non-surgically and patients with fractures of the femur around hip implants, 4 a reduction in the IMP minimum dose to allow accurate estimation of the minimum effective concentration of levobupivacaine in 50% of patients. 5 an improvement in the layout of the CRF form, 6 a change in the way data from the trial will be analysed, which will not affect the primary end point, 7 storage of the CRF (change of site due to building work), 8 details on the biochemical analysis of the blood samples taken in the second part of the study to determine the levels of drug in the blood.

    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
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