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    Clinical Trial Results:
    Analgesic effect of proximal supplemental obturator nerve block after insufficient analgesic effect of femoral nerve block in patients with hip fracture.

    Summary
    EudraCT number
    		 2015-000078-36
    Trial protocol
    		 DK  
    Global end of trial date
    27 Aug 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    protocol2tdn
    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 of the trail is to investigate if supplementing an insufficient femoral nerve block with an obturator nerve block has analgesic effect in patients with hip fracture
    Protection of trial subjects
    No trial subjects were included.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion: suspected hip fracture, successful sensory anesthesia after femoral nerve block, age >55, capable of cooperation, NRS > 3 at rest or >5 by passive straight leg lift 30 min after femoral nerve block. Exclusion: No hip fracture at x-ray, weight <45 kg, allergy to local anesthetic, infection in the area of nerve block.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was designed as a randomized, controlled, doubled-blinded trial, but he trial was never started.

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 The trial was never started and therefore no patients were enrolled. The trial was planned to be a randomized, controlled, double-blind trial with two arms. It is stated that one patient started this arm "overall trial", however this was only to be able to post and finalize the study in EudraCT, as the system will not accept at value of zero. In the protocol it was described that all patients with hip fracture would receive a femoral nerve block and after that patients would be randomized to receive an obturator nerve block with bupivacaine or saline.
    Arm type
    		 Trial not started, no patients were randomized

    Investigational medicinal product name
    Bupivacaine 0,25 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Planned per protocol: femoral nerve block with 15 mL bupivacaine and active obturator nerve block 15 mL bupivacaine

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Isotonic saline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Planned per protocol: placebo obturator nerve block with 15 mL

    Number of subjects in period 1
    		Overall trial
    Started
    1
    Completed
    0
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 The trial was never started and therefore no patients were enrolled. The trial was planned to be a randomized, controlled, double-blind trial with two arms. It is stated that one patient started this arm "overall trial", however this was only to be able to post and finalize the study in EudraCT, as the system will not accept at value of zero. In the protocol it was described that all patients with hip fracture would receive a femoral nerve block and after that patients would be randomized to receive an obturator nerve block with bupivacaine or saline.

    Primary: Frequency of sufficient analgesia 20 minutes after supplemental obturator nerve block

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    End point title
    		 Frequency of sufficient analgesia 20 minutes after supplemental obturator nerve block [1]
    End point description
    This was the primary outcome as defined in the protocol. Per protocol the primary outcome would compare the group with active and placebo obturator nerve block. No patients were enrolled in the trial and the trial was ended prematurely before any data were collected.
    End point type
    Primary
    End point timeframe
    20 minutes after obturator 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: No data were collected for the primary end point and therefore no statistical analyses were performed. The trial was ended prematurely before any patients were enrolled.
    End point values
    		 Overall trial
    Number of subjects analysed
    0 [2]
    Units: frequency
        Success
        Failure
    Notes
    [2] - The trial was ended prematurely, no patients were enrolled.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Timeframe defined in the protocol: 30 min after nerve block. No patients were included.
    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 ended prematurely before any patients were enrolled.

    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
    The trial was prematurely terminated as it was not possible to recruit any patients. No patients were enrolled before termination.
    -

    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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