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    Clinical Trial Results:
    RANDOMIZED AND CONTROLLED PHASE IV CLINICAL TRIAL ON THE ANALGESIC EFFECTIVENESS OF THE COMBINED BLOCKADE (PENG -PERICAPSULAR NERVE GROUP- AND THE FEMORAL LATERAL CUTANEOUS NERVE) IN THE HIP FRACTURES OF THE ELDERLY. COMPARATIVE STUDY BETWEEN LEVOBUPIVACAINE AND ROPIVACAINE.

    Summary
    EudraCT number
    		 2020-004697-21
    Trial protocol
    		 ES  
    Global end of trial date
    01 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jan 2022
    First version publication date
    29 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PENG-CAD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación IECSCYL-IBSAL.
    Sponsor organisation address
    Hospital Virgen de la Vega, 10ª Planta. Paseo de San Vicente, 58-182. , Salamanca, Spain, 37007
    Public contact
    Área de Ensayos Clínicos, SCReN-UICEC CAUSA/IBSAL, +34 9232911005779, ricardo.lopez@scren.es
    Scientific contact
    Área de Ensayos Clínicos, SCReN-UICEC CAUSA/IBSAL, 696022264 9232911005779, ricardo.lopez@scren.es
    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
    12 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the analgesic efficacy of both local anesthetics in the regional block of hip fracture surgery.
    Protection of trial subjects
    Adequate information of each patient and efficient monitoring of treatment safety through pharmacovigilance.
    Background therapy
    		 Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion
    Evidence for comparator
    		 Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion
    Actual start date of recruitment
    09 Feb 2021
    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
    Spain: 114
    Worldwide total number of subjects
    114
    EEA total number of subjects
    114
    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)
    0
    From 65 to 84 years
    41
    85 years and over
    73

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patient will have to voluntarily sign and understand the informed consent that will be provided in writing

    Pre-assignment
    Screening details
    		 Patients over 65 years of age, with a hip fracture, who are going to be operated on at the Salamanca University Assistance Complex (CAUSA), without allergy to any of the drugs, coagulation disorders, local infections instead of puncture or vascular prostheses at the femoral level.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomization was carried out using the SPSS © computer program (v. 25.0), generating two treatment groups in a simple random way (1: 1) with allocation in blocks (size 6) of the selected patients included in the study. Two “extra” allocation blocks were generated to assign patients derived from filling in patients withdrawn from the trial (criteria 6.6, PENG-CAD clinical trial protocol, v1 of September 1, 2020).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEVOBUPIVACAINE
    Arm description
    		 Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levobupivacaína Altan 7,5 mg/ml solución inyectable y para perfusión EFG
    Investigational medicinal product code
    78248
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarterial use
    Dosage and administration details
    0.25 % percent

    Arm title
    		 ROPIVACAINE
    Arm description
    		 Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion
    Investigational medicinal product code
    N01BB10
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarterial use
    Dosage and administration details
    0.25 % percent (0.375%)

    Number of subjects in period 1
    		LEVOBUPIVACAINE ROPIVACAINE
    Started
    57
    57
    Completed
    56
    52
    Not completed
    1
    5
         Screening failure
    -
    1
         The patient dies before starting the surgical proc
    1
    -
         Lack of efficacy
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEVOBUPIVACAINE
    Reporting group description
    		 Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion

    Reporting group title
    ROPIVACAINE
    Reporting group description
    		 Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion

    Reporting group values
    		 LEVOBUPIVACAINE ROPIVACAINE Total
    Number of subjects
    		 57 57 114
    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
    Patients older than 65 years
    Units: years
        median (standard deviation)
    		 86.40 ( 7.56 ) 86.13 ( 8.47 ) -
    Gender categorical
    Patients older than 65 years
    Units: Subjects
        Female
    		 41 46 87
        Male
    		 16 11 27
    Subject analysis sets

    Subject analysis set title
    Levobupivacaine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with Levobupivacaine included in final result

    Subject analysis set title
    Ropivacaine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with Ropivacaine included in final result

    Subject analysis sets values
    		 Levobupivacaine Ropivacaine
    Number of subjects
    56
    52
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Patients older than 65 years
    Units: years
        median (standard deviation)
    86.11 ( 5.52 )
    86.69 ( 6.22 )
    Gender categorical
    Patients older than 65 years
    Units: Subjects
        Female
    41
    43
        Male
    15
    9

    End points

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    End points reporting groups
    Reporting group title
    LEVOBUPIVACAINE
    Reporting group description
    		 Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion

    Reporting group title
    ROPIVACAINE
    Reporting group description
    		 Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion

    Subject analysis set title
    Levobupivacaine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with Levobupivacaine included in final result

    Subject analysis set title
    Ropivacaine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients treated with Ropivacaine included in final result

    Primary: Need for rescue drugs

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    End point title
    		 Need for rescue drugs
    End point description
    Need for rescue drugs at 6h, 12h, 24h and 48h.
    End point type
    Primary
    End point timeframe
    6h, 12h, 24h, 48h
    End point values
    		 LEVOBUPIVACAINE ROPIVACAINE
    Number of subjects analysed
    56
    52
    Units: number
        6h
    10
    4
        12h
    12
    14
        24h
    21
    17
        48h
    10
    14
        No rescue
    3
    3
    Statistical analysis title
    		 Rescue
    Comparison groups
    LEVOBUPIVACAINE v ROPIVACAINE
    Number of subjects included in analysis
    108
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Latency of initiation; EVN

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    End point title
    		 Latency of initiation; EVN
    End point description
    Assessed using EVN analgesic scale
    End point type
    Secondary
    End point timeframe
    6h, 12h, 24h and 48h
    End point values
    		 LEVOBUPIVACAINE ROPIVACAINE
    Number of subjects analysed
    56
    52
    Units: point
    median (standard deviation)
        6h
    1.92 ( 1.04 )
    1.68 ( 2.56 )
        12h
    2.50 ( 2.26 )
    2.91 ( 3.15 )
        24h
    4.33 ( 2.79 )
    3.50 ( 2.82 )
        48h
    4.72 ( 2.66 )
    4.58 ( 2.84 )
    No statistical analyses for this end point

    Secondary: Latency of initiation; Algoplus

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    End point title
    		 Latency of initiation; Algoplus
    End point description
    Assessed using Algoplus analgesic scale
    End point type
    Secondary
    End point timeframe
    6h, 12h 24h and 48h
    End point values
    		 LEVOBUPIVACAINE ROPIVACAINE
    Number of subjects analysed
    56
    52
    Units: Point
    median (standard deviation)
        6h
    0.94 ( 1.25 )
    0.75 ( 1.04 )
        12h
    1.30 ( 1.06 )
    1.38 ( 1.43 )
        24h
    2.16 ( 1.37 )
    1.70 ( 1.28 )
        48h
    2.32 ( 1.27 )
    2.21 ( 1.33 )
    No statistical analyses for this end point

    Secondary: Latency of initiation; PAINAD

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    End point title
    		 Latency of initiation; PAINAD
    End point description
    Assessed using PIANAD analgesic scale
    End point type
    Secondary
    End point timeframe
    6h, 12h, 24h and 48h
    End point values
    		 LEVOBUPIVACAINE ROPIVACAINE
    Number of subjects analysed
    56
    52
    Units: Point
    median (standard deviation)
        6h
    1.46 ( 2.05 )
    1.04 ( 1.67 )
        12h
    1.95 ( 1.69 )
    1.84 ( 1.99 )
        24h
    3.22 ( 1.99 )
    2.76 ( 2.17 )
        48h
    3.75 ( 2.23 )
    3.36 ( 2.14 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At 48 h it is considered the end of follow-up
    Adverse event reporting additional description
    At 48 h it is considered the end of follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 No one serious adverse events were detected.

    Serious adverse events
    		 Treated
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 108 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treated
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 108 (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 adverse events were detected. Allergic reactions, vascular punctures, nerve injuries, infections and toxicities due to the local anesthetic were evaluated but none were detected. A serious adverse event was detected. A patient who died of shock before study drugs could be applied. This patient signed the Informed Consent but is not evaluated in the study because he did not receive study 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.
    The age of the patients often makes it difficult for researchers to interpret pain scales. We did not see differences in the duration or quality of the block between the two anesthetics.
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