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    Clinical Trial Results:
    "AnAnkle Trial": Peripheral nerve block vs. spinal anaesthesia for ankle fracture surgery – implications on pain profile and quality of recovery

    Summary
    EudraCT number
    		 2015-001108-76
    Trial protocol
    		 DK  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-735
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    Department of Anaesthesiology I65N9, Herlev Hospital, rune.sort.03@regionh.dk
    Scientific contact
    Department of Anaesthesiology I65N9, Herlev Hospital, rune.sort.03@regionh.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
    31 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study difference in combined short term postoperative pain and opioid use following peripheral nerve block (PNB) anaesthesia versus spinal anaesthesia (SA) for ankle fracture surgery.
    Protection of trial subjects
    The interventions (peripheral nerve block anaesthesia versus spinal anaesthesia) were already part of standard clinical practice and performed with attention to minimising any pain, distress or discomfort, i.e. by providing thorough information, local anaesthesia and on-demand light sedation.
    Background therapy
    		 Both arms received peroperative light sedation on demand and a postoperative pain treatment regimen of paracetamol 1 g every 6 hours, ibuprofene 400 mg every 8 hours and PCA on-demand i.v. morphine 2,5 mg pr. dose with a 6 min lock-out interval and no background infusion.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    106
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible subjects were Danish speaking adults scheduled for acute internal fixation of an ankle fracture in two university hospitals in Copenhagen, Denmark. Treating physicians consecutively identify eligible subjects according to the listed criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PNB anaesthesia
    Arm description
    		 -
    Arm type
    		 Experimental

    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
    Ultrasound guided popliteal sciatic nerve block: Ropivacaine 7,5 mg/ml, 20 ml Ultrasound guided saphenous nerve block: Ropivacaine 7,5 mg/ml, 8 ml

    Arm title
    		 Spinal anasthesia
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    hyperbaric bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Spinal anaesthesia: Hyperbaric bupivacaine 5 mg/ml, 2 ml.

    Number of subjects in period 1
    		PNB anaesthesia Spinal anasthesia
    Started
    77
    73
    Completed
    77
    73

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PNB anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Spinal anasthesia
    Reporting group description
    		 -

    Reporting group values
    		 PNB anaesthesia Spinal anasthesia Total
    Number of subjects
    		 77 73 150
    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 (inter-quartile range (Q1-Q3))
    		 56 (43.5 to 65.5) 54 (40 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 51 46 97
        Male
    		 26 27 53

    End points

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    End points reporting groups
    Reporting group title
    PNB anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Spinal anasthesia
    Reporting group description
    		 -

    Primary: PIOC (pain intensity and opioid consumption) score

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    End point title
    		 PIOC (pain intensity and opioid consumption) score
    End point description
    End point type
    Primary
    End point timeframe
    0-27 hours post-anaesthesia
    End point values
    		 PNB anaesthesia Spinal anasthesia
    Number of subjects analysed
    77
    73
    Units: %
        median (standard deviation)
    -26.5 ± 87.4
    54.3 ± 93.6
    Statistical analysis title
    		 PIOC analysis
    Statistical analysis description
    PIOC is calculated by ranking both the NRS area under the curve (AUC) pain score and total morphine consumption 0-27 hours across both groups. PIOC is the summation of the deviations from the mean ranks for both parameters and equals -200% to +200% for each patient.
    Comparison groups
    PNB anaesthesia v Spinal anasthesia
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Morphine consumption

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    End point title
    		 Morphine consumption
    End point description
    End point type
    Secondary
    End point timeframe
    0-27 hours post-anaesthesia
    End point values
    		 PNB anaesthesia Spinal anasthesia
    Number of subjects analysed
    77
    73
    Units: mg i.v.
        median (inter-quartile range (Q1-Q3))
    20 (12.5 to 38.8)
    32.5 (18.1 to 65)
    Statistical analysis title
    		 Morphine consumption comparison
    Statistical analysis description
    Comparison of 0-27 hours morphine consumption.
    Comparison groups
    PNB anaesthesia v Spinal anasthesia
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: NRS-AUC pain score

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    End point title
    		 NRS-AUC pain score
    End point description
    End point type
    Secondary
    End point timeframe
    0-27 hours post-anaesthesia
    End point values
    		 PNB anaesthesia Spinal anasthesia
    Number of subjects analysed
    77
    73
    Units: NRS*hours
        median (inter-quartile range (Q1-Q3))
    37.5 (20.3 to 54)
    72 (43.5 to 102)
    Statistical analysis title
    		 Pain score comparison
    Statistical analysis description
    Numeric rating scale (NRS) area under the curve (AUC) 0-27 hours comparison.
    Comparison groups
    PNB anaesthesia v Spinal anasthesia
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 hours post-anaesthesia
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    PNB anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Spinal anaesthesia
    Reporting group description
    		 -

    Serious adverse events
    		 PNB anaesthesia Spinal anaesthesia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Nausea
    Additional description: Severe nausea causing an extra admission day before hospital discharge.
         subjects affected / exposed
    1 / 77 (1.30%)
    0 / 73 (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: 0%
    Non-serious adverse events
    		 PNB anaesthesia Spinal anaesthesia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 77 (7.79%)
    14 / 73 (19.18%)
    General disorders and administration site conditions
    Nausea
         subjects affected / exposed
    6 / 77 (7.79%)
    7 / 73 (9.59%)
         occurrences all number
    6
    7
    Renal and urinary disorders
    Urinary retention postoperative
         subjects affected / exposed
    0 / 77 (0.00%)
    7 / 73 (9.59%)
         occurrences all number
    0
    7

    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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28576901
    http://www.ncbi.nlm.nih.gov/pubmed/33546844
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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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