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    Clinical Trial Results:
    Comparison of ultrasound-guided PENG block and supra-inguinal fascia iliaca compartment block for postoperative pain and early motor recovery after total hip arthroplasty: a randomized controlled non-inferiority clinical trial

    Summary
    EudraCT number
    		 2020-005126-28
    Trial protocol
    		 BE  
    Global end of trial date
    06 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2026
    First version publication date
    03 Jun 2026
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    NA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Liège
    Sponsor organisation address
    Sart Tilman B35, Liège, Belgium,
    Public contact
    Michele Carella, CHU de Liège, mcarella@chuliege.be
    Scientific contact
    Michele Carella, CHU de Liège, mcarella@chuliege.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
    06 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In this study we primarily aimed at evaluating the influence of ropivacaine SFICB or PENG block on postoperative pain at rest and at mobilization in patients receiving spinal anesthesia for THAPL and the non-inferiority of PENG block on postoperative pain, opioid-sparing and global functional outcomes.
    Protection of trial subjects
    After a detailed explanation about the study rationale by the principal investigator, written informed consent was obtained before inclusion of eligible patients into the trial. This study follows the applicable CONSORT guidelines and was performed in accordance with the most recent version of the Helsinki Declaration. Data acquisition occurred be- tween 11 October 2021 and 6 July 2022 at the University Hospital of Liege, Belgium.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 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
    Belgium: 106
    Worldwide total number of subjects
    106
    EEA total number of subjects
    106
    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)
    5
    From 65 to 84 years
    89
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 Data acquisition occurred be- tween 11 October 2021 and 6 July 2022 at the University Hospital of Liege, Belgium. Patients scheduled to undergo elective PLTHA under spinal anaesthesia were consecutively and prospectively considered as eligible for inclusion.

    Pre-assignment
    Screening details
    		 Patients scheduled to undergo elective PLTHA under spinal anaesthesia

    Period 1
    Period 1 title
    Main period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SFIB
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Ultrasound-guided supra-inguinal fascia iliaca block (SFIB) performed after spinal anaesthesia. Single perineural injection of 40 mL ropivacaine 0.375% in the fascia iliaca compartment to target femoral, lateral femoral cutaneous, and obturator nerve branches. No catheter placement.

    Arm title
    		 PENG
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Ultrasound-guided pericapsular nerve group (PENG) block performed after spinal anaesthesia. Single perineural injection of 20 mL ropivacaine 0.75% into the fascial plane between the psoas tendon and pubic ramus. No catheter left in situ.

    Number of subjects in period 1
    		SFIB PENG
    Started
    53
    53
    Completed
    53
    53
    Period 2
    Period 2 title
    Recruitment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PENG
    Arm description
    		 PENG with 20ml of ropivacaine 0.75%
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Ultrasound-guided pericapsular nerve group (PENG) block performed after spinal anaesthesia. Single perineural injection of 20 mL ropivacaine 0.75% into the fascial plane between the psoas tendon and pubic ramus. No catheter left in situ.

    Arm title
    		 SFIB
    Arm description
    		 SFIB with 40ml of ropivacaine 0.375%
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Ultrasound-guided supra-inguinal fascia iliaca block (SFIB) performed after spinal anaesthesia. Single perineural injection of 40 mL ropivacaine 0.375% in the fascia iliaca compartment to target femoral, lateral femoral cutaneous, and obturator nerve branches. No catheter placement.

    Number of subjects in period 2
    		PENG SFIB
    Started
    53
    53
    Completed
    51
    51
    Not completed
    2
    2
         Protocol deviation
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main period
    Reporting group description
    		 -

    Reporting group values
    		 Main period Total
    Number of subjects
    		 106 106
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 89 89
        85 years and over
    		 12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.5 ( 11.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 61 61
        Male
    		 45 45
    Subject analysis sets

    Subject analysis set title
    SFIB group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Group SFIB

    Subject analysis set title
    PENG group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    PENG group

    Subject analysis sets values
    		 SFIB group PENG group
    Number of subjects
    51
    51
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    3
    2
        From 65-84 years
    42
    43
        85 years and over
    6
    6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.8 ( 12.7 )
    68.2 ( 10.5 )
    Gender categorical
    Units: Subjects
        Female
    30
    27
        Male
    21
    24

    End points

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    End points reporting groups
    Reporting group title
    SFIB
    Reporting group description
    		 -

    Reporting group title
    PENG
    Reporting group description
    		 -
    Reporting group title
    PENG
    Reporting group description
    		 PENG with 20ml of ropivacaine 0.75%

    Reporting group title
    SFIB
    Reporting group description
    		 SFIB with 40ml of ropivacaine 0.375%

    Subject analysis set title
    SFIB group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Group SFIB

    Subject analysis set title
    PENG group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    PENG group

    Primary: Rest NRS pain 6h postop

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    End point title
    		 Rest NRS pain 6h postop
    End point description
    Rest pain
    End point type
    Primary
    End point timeframe
    6 hours after surgery
    End point values
    		 PENG SFIB
    Number of subjects analysed
    51
    51
    Units: NRS 0-10
    number (confidence interval 95%)
        NRS
    2.3 (1.8 to 2.8)
    2.1 (1.6 to 2.6)
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    Non-inferiority analysis of rest pain NRS at 6 hours postoperatively A pre-specified non-inferiority analysis was performed to compare postoperative rest pain intensity between the PENG and SFIB groups at 6 hours after total hip arthroplasty. The non-inferiority margin was set at 1 numeric rating scale (NRS) point. The between-group difference was estimated using a Mann–Whitney U test, with calculation of median difference and 95% confidence interval. Non-inferiority was concluded if the uppe
    Comparison groups
    PENG v SFIB
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.001
    Method
    		 Mann–Whitney U test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 hours after surgery
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    PENG
    Reporting group description
    		 -

    Reporting group title
    SFIB
    Reporting group description
    		 -

    Serious adverse events
    		 PENG SFIB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (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: 3%
    Non-serious adverse events
    		 PENG SFIB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 51 (11.76%)
    6 / 51 (11.76%)
    Gastrointestinal disorders
    Postoperative nausea or vomiting (PONV)
         subjects affected / exposed
    6 / 51 (11.76%)
    6 / 51 (11.76%)
         occurrences all number
    6
    6

    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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