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    Clinical Trial Results:
    Risk factors and Prevention of severe Pain upon cessation of a peripheral nerve block. A prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.

    Summary
    EudraCT number
    		 2019-001079-35
    Trial protocol
    		 BE  
    Global end of trial date
    21 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2022
    First version publication date
    25 Dec 2022
    Other versions
    Summary report(s)
    		 PRPK Summary Results

    Trial information

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    Trial identification
    Sponsor protocol code
    PRPK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cliniques Universitaires Saint Luc
    Sponsor organisation address
    Avenue Hippocrate, 10, Bruxelles, Belgium, 1200
    Public contact
    Lavand'homme Patricia, Cliniques Universitaires Saint Luc, patricia.lavandhomme@saintluc.uclouvain.be
    Scientific contact
    Lavand'homme Patricia, Cliniques Universitaires Saint Luc, patricia.lavandhomme@saintluc.uclouvain.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
    29 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study will assess pain and recovery after single shot axillary plexus block in ambulatory patients undergoing upper limb bone surgery. We will try to identify risk factors for severe pain when the PNB wears off.
    Protection of trial subjects
    Insurrance was taken. Except for the study specific interventions, patients were treated as per standard of care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2020
    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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    86
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients between 18 and 80 yr of age scheduled for elective ambulatory upper limb surgery (elbow and under) under anaxillary plexus block were prospectively enrolled between January 2019 and March 2021. Patients were recruited during preoperative surgical or anaesthesia visit.

    Pre-assignment
    Screening details
    		 Incl. Crit.: - ambulatory upper limb bone surgery done under axillary PNB - age: 18 to 75 yrs old Excl. Crit: - contraindication to: use of ketamine or regular use of usual postoperative analgesics - pregnant woman - diabetic or vascular patient - cognitive disorder - inhability to answer perioperative questionnaires

    Pre-assignment period milestones
    Number of subjects started
    		 110
    Number of subjects completed
    		 109

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Lost of FU: 1
    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, Carer
    Blinding implementation details
    Randomization preparation and conservation by pharmacy of anonymized syringes in anonymous envelopes. The syringes were given to the anesthetist doctor who remainded blinded, and were injected in the intervention room under standard monitoring.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ketamine
    Arm description
    		 Group injected with 0.3 mg/kg intravenous ketamine diluted into 10mL saline
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.3 mg/kg intravenous ketamine diluted into 10mL saline - slow intravenous injection after the realization of PNB, before tourniquet set up and beginning of surgery.

    Investigational medicinal product name
    NaCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.3 mg/kg intravenous ketamine diluted into 10mL saline - slow intravenous injection after the realization of PNB, before tourniquet set up and beginning of surgery.

    Arm title
    		 Placebo
    Arm description
    		 Slow intravenous injection of 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mL 0.9% saline solution (NaCL)

    Number of subjects in period 1 [1]
    		Ketamine Placebo
    Started
    54
    55
    Completed
    54
    55
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Overall trial results are showing only data collected on patients who completed the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ketamine
    Reporting group description
    		 Group injected with 0.3 mg/kg intravenous ketamine diluted into 10mL saline

    Reporting group title
    Placebo
    Reporting group description
    		 Slow intravenous injection of 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery

    Reporting group values
    		 Ketamine Placebo Total
    Number of subjects
    		 54 55 109
    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)
    		 51 ± 16 52 ± 18 -
    Gender categorical
    Units: Subjects
        Female
    		 29 28 57
        Male
    		 25 27 52

    End points

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    End points reporting groups
    Reporting group title
    Ketamine
    Reporting group description
    		 Group injected with 0.3 mg/kg intravenous ketamine diluted into 10mL saline

    Reporting group title
    Placebo
    Reporting group description
    		 Slow intravenous injection of 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery

    Primary: Incidence of Rebound Pain after upper limb surgery under axillary plexus block

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    End point title
    		 Incidence of Rebound Pain after upper limb surgery under axillary plexus block [1]
    End point description
    End point type
    Primary
    End point timeframe
    Post-operative - When block wear off
    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: For the incidence of rebound pain, ratio/percentages were used.
    End point values
    		 Ketamine Placebo
    Number of subjects analysed
    54
    55
    Units: Incidence RP (n)
        With Rebound Pain when block wear off
    18
    26
        Without Rebound Pain when block wear off
    36
    29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall trial
    Adverse event reporting additional description
    From enrollment untill completion of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD 10 - Enfglish
    Dictionary version
    2015
    Reporting groups
    Reporting group title
    Ketamine
    Reporting group description
    		 Group injected with 0.3 mg/kg intravenous ketamine diluted into 10mL saline

    Reporting group title
    Placebo
    Reporting group description
    		 Slow intravenous injection of 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery

    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 information about non-serious adverse events were received.
    Serious adverse events
    		 Ketamine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Anaphylactic reaction
    Additional description: Anaphylactic reaction on standard of care administration of NSAIDs. Unrelated to the study procedures. Event resolved without sequelae.
    alternative dictionary used: MedDRA 23.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ketamine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 55 (0.00%)

    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/35219449
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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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