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    Clinical Trial Results:
    Intravenous regional anesthesia versus axillar block for hand surgery in day-care hospitall: A prospective, randomised, comparative trial

    Summary
    EudraCT number
    		 2016-002325-11
    Trial protocol
    		 BE  
    Global end of trial date
    07 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2019
    First version publication date
    30 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AT052016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium,
    Public contact
    Anesthesie Research, University Hospital Leuven, christel.huygens@uzleuven.be
    Scientific contact
    Anesthesie Research, University Hospital Leuven, christel.huygens@uzleuven.be
    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
    08 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    No difference in patient satisfaction scores for both groups
    Protection of trial subjects
    All patients received prophylactic pain medication (paracetamol, ketorolac) according to the protocol. Pain scores (intra-operative and post-operative) were monitored frequently. Other adverse events (e.g. postoperative nausea and vomiting, neurological symptoms) were evaluated until dicharge and one day after surgery (by telephone). All measures to prevent discomfort and pain were described in detail in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    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
    Belgium: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    95
    From 65 to 84 years
    24
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this prospective, randomized controlled trial, we enrolled 120 patients undergoing carpal tunnel release, resection of a wrist cyst or Dupuytren release (with a maximum of 2 strands) under RA in an ambulatory setting. We included only patients with an American Society of Anesthesiologists physical status I - III, ≥ 18 years of age, scheduled f

    Pre-assignment period milestones
    Number of subjects started
    		 120
    Number of subjects completed
    		 120

    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
    		 Intravenous regional anaesthesia
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocain
    Investigational medicinal product code
    Other name
    IVRA
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg total volume of 40 mL In patients allocated to the IVRA-group, all anesthetic measures were performed in the operation room (OR). A cannula (22G, BD Insyte-W; Becton,Dickinson Benelux N.V., Erembodegem, Belgium) was inserted into a vein on the back of the hand at the operative side. A tourniquet with a double cuff was attached around the upper arm. Then, an Esmarch was wrapped tightly while lifting the arm, thereby exsanguinating the arm.16 Subsequently, the proximal cuff of the tourniquet was insufflated to 250 mmHg, and the Esmarch was removed. 300 mg of lidocaine in a total volume of 40 mL was injected slowly through the intravenous catheter, which was removed afterwards.

    Arm title
    		 Axillary block
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    mepivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    280 mg (mepivacain 1%) total volume 28 ml In patients allocated to receive an axillary block, regional anesthesia was performed in the preoperative preparation and block room. The arm to be operated was abducted at 90° and the forearm flexed to a 90° angle. With the use of ultrasound, the following 4 nerves were identified as hyperechoic structures: the median, ulnar and radial nerve surrounding the axillary artery and the musculocutaneous nerve in the fascial layers between the biceps and coracobrachialis muscles. Local anesthesia of the puncture site was achieved with a subcutaneous injection of 2 mL lidocaine 1%. The needle (Stimuplex® Ultra 360 0.71x 50mm; G 22; B. Braun® Medical Inc., Melsungen, Hessen, Germany) was inserted in the axilla under ultrasound guidance with the probe in plane.14 Both ultrasound and neuro-stimulation were used to detect the nerves and to decrease the risk of intra-neural puncture/injection. After the initial motor response of the median nerve was obta

    Number of subjects in period 1
    		Intravenous regional anaesthesia Axillary block
    Started
    60
    60
    Completed
    60
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intravenous regional anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Axillary block
    Reporting group description
    		 -

    Reporting group values
    		 Intravenous regional anaesthesia Axillary block Total
    Number of subjects
    		 60 60 120
    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
        arithmetic mean (standard deviation)
    		 53 ( 16 ) 50 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 32 63
        Male
    		 29 28 57
    ASA
    Units: Subjects
        ASA 1
    		 24 32 56
        ASA 2
    		 26 24 50
        ASA 3
    		 10 4 14
    weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 75 ( 15 ) 76 ( 15 ) -
    height
    Units: centimeter
        arithmetic mean (standard deviation)
    		 170 ( 8 ) 171 ( 10 ) -

    End points

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    End points reporting groups
    Reporting group title
    Intravenous regional anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Axillary block
    Reporting group description
    		 -

    Primary: Patient satisfaction

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    End point title
    		 Patient satisfaction
    End point description
    Patient satisfaction was evaluated using the “Evaluation du Vécu de l’ Anesthésie LocoRegional” (EVAN-LR) questionnaire which was specially developed for the evaluation of patient satisfaction after RA.18 (Addendum 1) In addition, patients were asked if they would choose the same anesthesia technique in the future. All questions were completed just before discharge, except for those items, which are home related (question 12-13-14). These questions were asked during a postoperative phone call interview at day 1 during which patients were also asked for the occurrence of adverse events and postoperative pain.
    End point type
    Primary
    End point timeframe
    Day of surgery and day after surgery (see description).
    End point values
    		 Intravenous regional anaesthesia Axillary block
    Number of subjects analysed
    60
    60
    Units: score
        median (inter-quartile range (Q1-Q3))
    92 (87 to 96)
    97 (87 to 97)
    Statistical analysis title
    		 patient satisfaction
    Comparison groups
    Intravenous regional anaesthesia v Axillary block
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: NRS for pain

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    End point title
    		 NRS for pain
    End point description
    End point type
    Secondary
    End point timeframe
    Intra-oparative (day of surgery)
    End point values
    		 Intravenous regional anaesthesia Axillary block
    Number of subjects analysed
    60
    60
    Units: score
        median (inter-quartile range (Q1-Q3))
    0 (0 to 2)
    0 (0 to 0)
    Statistical analysis title
    		 NRS for pain intra-operatively
    Comparison groups
    Intravenous regional anaesthesia v Axillary block
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: VAS pain score postopartively

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    End point title
    		 VAS pain score postopartively
    End point description
    VAS score for pain post-operatively
    End point type
    Secondary
    End point timeframe
    Day of surgery
    End point values
    		 Intravenous regional anaesthesia Axillary block
    Number of subjects analysed
    60
    60
    Units: score
        median (inter-quartile range (Q1-Q3))
    0.79 (0 to 1.76)
    0 (0 to 0.25)
    Statistical analysis title
    		 VAS score postoperatively
    Comparison groups
    Axillary block v Intravenous regional anaesthesia
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PONV medication

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    End point title
    		 PONV medication
    End point description
    Need for treatment for postoperative nausea and vomiting (day of surgery)
    End point type
    Secondary
    End point timeframe
    Until discharge
    End point values
    		 Intravenous regional anaesthesia Axillary block
    Number of subjects analysed
    60
    60
    Units: number
        Yes
    1
    1
        No
    59
    59
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During surgery Postoperatively (day of surgery until discharge DSU) Day 1 after surgery (by telephone conversation)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Intravenous regional anaesthesia
    Reporting group description
    		 -

    Reporting group title
    Axillary block
    Reporting group description
    		 -

    Serious adverse events
    		 Intravenous regional anaesthesia Axillary block
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intravenous regional anaesthesia Axillary block
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 60 (11.67%)
    8 / 60 (13.33%)
    Nervous system disorders
    numbness of hand/fingers
         subjects affected / exposed
    7 / 60 (11.67%)
    3 / 60 (5.00%)
         occurrences all number
    10
    10
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2

    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/30035357
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