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    Clinical Trial Results:
    Analgesic duration of a preoperative single-shot femoral nerve block with Bupivacaine and adjuvant Dexamethasone in patients with hip fracture

    Summary
    EudraCT number
    		 2014-001702-18
    Trial protocol
    		 DK  
    Global end of trial date
    27 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2021
    First version publication date
    19 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    protocol1tdn
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Dep. Anaesthesia, Aarhus University Hospital, +45 28782877, thomas.dahl.nielsen@clin.au.dk
    Scientific contact
    Dep. Anaesthesia, Aarhus University Hospital, +45 28782877, thomas.dahl.nielsen@clin.au.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
    27 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective is to investigate if the addition of Dexamethasone to Bupivacaine for preoperative analgesia with a femoral nerve block in patients with hip fracture results in prolonged analgesia compared to plain Bupivacaine without Dexamethasone
    Protection of trial subjects
    This trial was conducted in accordance with the Declaration of Helsinki. The trial was approved by the Danish Medicines Agency, the Central Denmark Region Committees on Health Research Ethics, and the Danish Data Protection Agency. The trial was monitored by the Good Clinical Practice Unit at Aarhus and Aalborg University Hospitals. Prior to inclusion, written informed consent was obtained from the patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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
    0
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 INCLUSION: Suspected hip fracture, age > 50 yrs, capable of following instructions per protocol, arrival to ER at hours where anesthesiologists involved in the study are present, NRS pain score > 4 at time of inclusion. EXCLUSION: No hip fracture at X-ray, weight < 40 kg.

    Period 1
    Period 1 title
    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
    		 Protracted femoral nerve block
    Arm description
    		 Bupivacaine 0.5% + adrenaline 5 microgram/mL, 15 mL + 8 mg (2 mL) dexamethasone for femoral nerve block
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine 0.5% + adrenaline 5 micrograms/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Bupivacaine 0.5% + adrenaline 5 micrograms/mL, 15 mL

    Investigational medicinal product name
    Dexamethasone 4 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2 mL for femoral nerve block.

    Arm title
    		 Plain femoral nerve block
    Arm description
    		 -
    Arm type
    		 Control

    Investigational medicinal product name
    Bupivacaine 0.5% + adrenaline 5 micrograms/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Bupivacaine 0.5% + adrenaline 5 micrograms/mL, 15 mL

    Investigational medicinal product name
    Sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    Isotonic saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    2 mL for femoral nerve block.

    Number of subjects in period 1
    		Protracted femoral nerve block Plain femoral nerve block
    Started
    2
    1
    Completed
    0
    0
    Not completed
    2
    1
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Protracted femoral nerve block
    Reporting group description
    		 Bupivacaine 0.5% + adrenaline 5 microgram/mL, 15 mL + 8 mg (2 mL) dexamethasone for femoral nerve block

    Reporting group title
    Plain femoral nerve block
    Reporting group description
    		 -

    Primary: Success rate of analgesia

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    End point title
    		 Success rate of analgesia [1]
    End point description
    Success is defined as minimum 24 hours of analgesia after femoral nerve block.
    End point type
    Primary
    End point timeframe
    24 hours after nerve block.
    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: The trial was terminated prematurely before any data regarding endpoints were collected. Therefore no statistical analysis could be performed.
    End point values
    		 Protracted femoral nerve block Plain femoral nerve block
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: frequency
        Success
        Failure
    Notes
    [2] - No statistical analysis performed due to early termination.
    [3] - No statistical analysis performed due to early termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24 hours after femoral nerve block.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    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: The trial was terminated prematurely. Only three patients were enrolled and none of them received the randomized treatment.

    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? Yes
    Date
    Interruption
    Restart date
    27 Aug 2015
    Recruitment was not feasible
    -

    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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    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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