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    Clinical Trial Results:
    The effect of subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery

    Summary
    EudraCT number
    		 2016-000608-27
    Trial protocol
    		 DK  
    Global end of trial date
    28 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2018
    First version publication date
    23 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ProtokolSB2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02697955
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Nørrebrogade 44, Aarhus C, Denmark, 8000
    Public contact
    Sponsor: Thomas Fichtner Bendtsen, Aarhus University Hospital Department of Anesthesiology and Intensive Care Medicine, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Sponsor: Thomas Fichtner Bendtsen, Aarhus University Hospital Department of Anesthesiology and Intensive Care Medicine, +45 51542997, tfb@dadlnet.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
    25 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to conduct a prospective, randomized, controlled, double-blinded trial to compare saphenous nerve block with bupivacaine-epinephrine vs. placebo to investigate the effect of a saphenous block as a supplement to sciatic nerve block after major ankle surgery. We hypothesized that a saphenous nerve block reduces the proportion of patients experiencing significant clinical pain after major ankle surgery.
    Protection of trial subjects
    The study was monitored by the Good Clinical Practice Unit at Aarhus and Aalborg University Hospitals In this study all patients received a sciatic nerve block according to the standard treatment at the department. The patients were randomized to active or placebo saphenous nerve block, but the observation period ended when the patient reported significant clinical pain (NRS > 3), and the patient immediately received a rescue saphenous nerve block.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    7
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was enrolled 21 June 2016, and the last patient was enrolled and completed 28 February 2017. All patients were enrolled at the foot and ankle surgery section at the Department of Orthopedic Surgery, Aarhus University Hospital, Denmark.

    Pre-assignment
    Screening details
    		 44 patients were screened. Reasons for primary exclusion: - Operation type not included (n=6) - Logistical reasons (n=6) - Daily intake of opioids (n=3) - Inability to cooperate (n=2) - Neuropathy/reduced sensation (n=5) - Charcot-Marie-Tooth disease (n=1) - Severe co-morbidity (n=3)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Saphenous nerve block in the femoral triangle with 10 mL 0.5 % bupivacaine with 1:200,000 epinephrine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine-epinephrine
    Investigational medicinal product code
    Other name
    Marcaine-adrenaline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Single-injection saphenous nerve block with 10 ml Marcaine-adrenaline. 1 ml Marcaine-adrenaline contains 5 mg bupivacainehydrochloride and 5 micrograms adrenaline as tartrate.

    Arm title
    		 Placebo
    Arm description
    		 Saphenous nerve block in the femoral triangle with 10 mL saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride 0.9 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Single-injection saphenous nerve block with 10 ml Sodium chloride 0.9 %

    Number of subjects in period 1
    		Active Placebo
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Saphenous nerve block in the femoral triangle with 10 mL 0.5 % bupivacaine with 1:200,000 epinephrine

    Reporting group title
    Placebo
    Reporting group description
    		 Saphenous nerve block in the femoral triangle with 10 mL saline

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 9 9 18
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 4 3 7
        From 65-84 years
    		 5 6 11
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.9 ± 7.6 66.7 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 2 5 7
        Male
    		 7 4 11
    ASA physical status
    ASA = American Society of Anesthesiologists
    Units: Subjects
        ASA I
    		 5 3 8
        ASA II
    		 4 6 10
    Surgical procedures
    Units: Subjects
        Total ankle arthroplasty
    		 3 6 9
        Ankle arthrodesis
    		 1 0 1
        Subtalar arthrodesis
    		 0 1 1
        Triple arthrodesis
    		 5 2 7
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 84.6 ± 18.2 83.3 ± 11.7 -
    Height
    Units: meter
        arithmetic mean (standard deviation)
    		 1.76 ± 0.11 1.71 ± 0.08 -
    BMI
    BMI = Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.0 ± 3.5 28.4 ± 3.4 -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Saphenous nerve block in the femoral triangle with 10 mL 0.5 % bupivacaine with 1:200,000 epinephrine

    Reporting group title
    Placebo
    Reporting group description
    		 Saphenous nerve block in the femoral triangle with 10 mL saline

    Primary: Number of patients experiencing significant clinical pain (NRS > 3)

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    End point title
    		 Number of patients experiencing significant clinical pain (NRS > 3)
    End point description
    Significant clinical pain at rest is defined as NRS > 3 at any time during the observation period
    End point type
    Primary
    End point timeframe
    Patients were observed postoperatively until NRS > 3 or up until 120 minutes after the end of surgery. Pain scores were evaluated at: Arrival at PACU and 30, 45, 60, 75, 90, 105 and 120 min after the end of surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    9
    9
    Units: Subjects
        NRS > 3
    1
    8
        NRS ≤ 3
    8
    1
    Statistical analysis title
    		 Fischer’s exact test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Fisher exact
    Confidence interval

    Secondary: The maximal reported pain score (NRS) during the observation period

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    End point title
    		 The maximal reported pain score (NRS) during the observation period
    End point description
    NRS = numerical rating scale 0-10
    End point type
    Secondary
    End point timeframe
    Patients were observed postoperatively until NRS > 3 or up until 120 minutes after the end of surgery. Pain scores (NRS) were evaluated at: Arrival at PACU and 30, 45, 60, 75, 90, 105 and 120 min after the end of surgery.
    End point values
    		 Active Placebo
    Number of subjects analysed
    9
    9
    Units: number
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    5 (4 to 6)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Sensory testing of the infrapatellar branch

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    End point title
    		 Sensory testing of the infrapatellar branch
    End point description
    The sensory test was performed as a pinprick test with a neuropen applying a standardized pressure of 40 g. The infrapatellar branch of the saphenous nerve was tested at the midpoint of a line connecting the medial femoral condyle and the tibial tuberosity. Sensation to pinprick was graded on a 3 point scale: 0 = no sensation, 1 = reduced sensation and 2 = normal sensation to pinprick compared to the contralateral side.
    End point type
    Secondary
    End point timeframe
    Baseline test and at the time when the patient reported NRS > 3 during the observation period. In case of NRS ≤ 3 during the entire observation period, sensory testing was conducted at t = 120 min
    End point values
    		 Active Placebo
    Number of subjects analysed
    9
    9
    Units: Subjects
        Normal cutaneous sensation (pinprick score 2)
    0
    9
        Reduced cutaneous sensation (pinprick score 1)
    1
    0
        No cutaneous sensation (pinprick score 0)
    8
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Reporting period: 21 Jun 2016 until 28 Feb 2017. Each patient was observed for adverse events from study treatment was given (randomized saphenous nerve block) and until the end of the observation period (maximum 120 min after the end of surgery)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    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: No non-serious adverse events were observed in this trial. The study was small with only 18 patients. The trial period was of very short duration, and the study intervention very similar to the normal standard 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? 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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    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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