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    Clinical Trial Results:
    Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, patient-masked trial.

    Summary
    EudraCT number
    		 2010-024100-10
    Trial protocol
    		 NL  
    Global end of trial date
    03 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    20 Nov 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OZR-2010-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR2820
    Sponsors
    Sponsor organisation name
    The Rotterdam Eye Hospital
    Sponsor organisation address
    PO Box 70030, Rotterdam, Netherlands, 3000LM
    Public contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    Scientific contact
    Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, +31 10 4023449, roi@oogziekenhuis.nl
    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
    02 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the beneficial effect of a single dose of 150 µg clonidine as an adjuvant to chirocaine in retrobulbar block.
    Protection of trial subjects
    Blood pressure monitored during surgery.
    Background therapy
    		 Clonidine, an α2-adrenergic receptor agonist, appears to mediate sedation, anxiolysis and analgesia. Its working mechanism, however, is still a matter of debate (Hoffman 2001; Bergendahl 2002). As an adjuvant in neuraxial local anaesthesia, clonidine is generally recognized to prolong motor block and analgesia (e.g. see Elia et al. 2008). Besides, it has been suggested that the effect of local anaesthetics on peripheral nerves blockade can also be prolonged by the use of clonidine as an adjuvant. Thus, it might help to reduce both post-operative pain and the post-operative use of rescue analgesics.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2011
    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
    Netherlands: 101
    Worldwide total number of subjects
    101
    EEA total number of subjects
    101
    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)
    83
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled for retinal detachment surgery with cryocoagulation and episcleral explant were asked to participate (age > 18 yrs; n=120).

    Pre-assignment
    Screening details
    		 Hypersensitivity to clonidine, oral use of clonidine, severe bradyarrhythmia, bipolar disorder, and history of renal insufficiency.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Clonidine group
    Arm description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    clonidine
    Investigational medicinal product code
    RVG 06055
    Other name
    Catapresan
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Retrobulbar use
    Dosage and administration details
    150 μg (micrograms)

    Number of subjects in period 1
    		Control group Clonidine group
    Started
    52
    49
    Completed
    52
    49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml.

    Reporting group title
    Clonidine group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.

    Reporting group values
    		 Control group Clonidine group Total
    Number of subjects
    		 52 49 101
    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)
    		 55.5 ± 11.2 55.5 ± 11.1 -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 30 30 60

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml.

    Reporting group title
    Clonidine group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.

    Subject analysis set title
    Mixed model analysis for pain score
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Mixed model analysis for repeated measurements

    Primary: Pain score on 10 cm Visual Analogue Scale (VAS) at postoperative day 1.

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    End point title
    		 Pain score on 10 cm Visual Analogue Scale (VAS) at postoperative day 1.
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative day 1.
    End point values
    		 Control group Clonidine group
    Number of subjects analysed
    52
    49
    Units: percentage
        VAS-0: score = 0
    24
    23
        VAS-1: score < 1
    14
    13
        VAS-2: score > 1
    14
    13
    Statistical analysis title
    		 Mixed model analysis pain score.
    Statistical analysis description
    Mixed model analysis for repeated measurements.
    Comparison groups
    Control group v Clonidine group
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day of surgery.
    Adverse event reporting additional description
    Monitoring of blood pressure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml.

    Reporting group title
    Clonidine group
    Reporting group description
    		 Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.

    Serious adverse events
    		 Control group Clonidine group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 49 (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: 0%
    Non-serious adverse events
    		 Control group Clonidine group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 49 (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: Five patients of each group had postoperative diastolic pressure below 60 mm Hg. As systolic pressure was > 100 mm Hg for all 10 patients, this was not considered to be an adverse event.

    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/25188774
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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
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