Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    The effect of iliopsoas plane block on opioid consumption and pain after hip arthroscopy A double-blind randomized, controlled trial

    Summary
    EudraCT number
    		 2020-005838-15
    Trial protocol
    		 DK  
    Global end of trial date
    04 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2024
    First version publication date
    22 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    04-22032021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard, Aarhus, Denmark, 8200
    Public contact
    Thomas Fichtner Bendtsen, Aarhus University Hospital, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Thomas Fichtner Bendtsen, Aarhus University Hospital, +45 51542997, tfb@dadlnet.dk
    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
    21 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the trial is to assess the analgesic effect of preoperatively placed active or placebo iliopsoas plane block for elective primary hip arthroscopy. The primary objective of the study is to investigate morphine consumption
    Protection of trial subjects
    The trial was approved by the Central Denmark Region Committee on Health Research Ethics (1-10-72-13-21) and the Danish Medicines Agency
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2021
    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
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Patients eligible for ambulatory hip arthroscopy surgery indicated by femoroacetabular impingement disease were included according to in- and exclusion criterias

    Pre-assignment
    Screening details
    		 Patients were screened for inclusion at the first ambulatory contact at Horsens Regional Hospital, Horsens, Denmark, and informed oral and written consent was obtained before surgery. Patients eligible for ambulatory hip arthroscopy surgery indicated by femoroacetabular impingement disease were included.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active IPB
    Arm description
    		 Active iliopsoas plane block
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine 5 mg/ mL+epinephrine 5 μg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL: bupivacaine 5 mg/mL + epinephrine 5 μg/mL

    Arm title
    		 Placebo IPB
    Arm description
    		 Placebo iliopsoas plane block
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline 9 mg/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Perineural use
    Dosage and administration details
    10 mL saline 9 mg/mL

    Number of subjects in period 1
    		Active IPB Placebo IPB
    Started
    25
    25
    Completed
    24
    25
    Not completed
    1
    0
         Physician decision
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group values
    		 Intervention Total
    Number of subjects
    		 50 50
    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)
    		 50 50
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 23 23

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Active IPB
    Reporting group description
    		 Active iliopsoas plane block

    Reporting group title
    Placebo IPB
    Reporting group description
    		 Placebo iliopsoas plane block

    Primary: IV morphine equivalent consumption

    		 Close Top of page
    End point title
    		 IV morphine equivalent consumption
    End point description
    End point type
    Primary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: mg
        arithmetic mean (standard deviation)
    10.4 ( 5.5 )
    23.8 ( 9.6 )
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Active IPB v Placebo IPB
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
    Variability estimate
    Standard deviation

    Secondary: Numeric Rating Scale (NRS) pain score

    		 Close Top of page
    End point title
    		 Numeric Rating Scale (NRS) pain score
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: NRS
        geometric mean (inter-quartile range (Q1-Q3))
    6 (5 to 7)
    7 (5 to 8)
    No statistical analyses for this end point

    Secondary: Quadriceps strength

    		 Close Top of page
    End point title
    		 Quadriceps strength
    End point description
    Quadriceps strength difference (ratio). A proportion where the numerator was preoperative strength minus postoperative strength and the denominator was preoperative strength
    End point type
    Secondary
    End point timeframe
    Before the nerve block (time 0) and after 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    24
    Units: ratio
        arithmetic mean (standard deviation)
    -0.427 ( 0.28 )
    -0.356 ( 0.29 )
    No statistical analyses for this end point

    Secondary: Intraoperative hip traction time

    		 Close Top of page
    End point title
    		 Intraoperative hip traction time
    End point description
    End point type
    Secondary
    End point timeframe
    Time traction was applied until the termination of hip traction
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: min
        arithmetic mean (standard deviation)
    23 ( 6 )
    22 ( 6 )
    No statistical analyses for this end point

    Secondary: Duration of anesthesia

    		 Close Top of page
    End point title
    		 Duration of anesthesia
    End point description
    End point type
    Secondary
    End point timeframe
    Induction of anesthesia until removal of the laryngeal mask
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: minute
        arithmetic mean (standard deviation)
    68 ( 12 )
    67 ( 10 )
    No statistical analyses for this end point

    Secondary: Intraoperative consumption of propofol

    		 Close Top of page
    End point title
    		 Intraoperative consumption of propofol
    End point description
    End point type
    Secondary
    End point timeframe
    From start til end of the anesthesia
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: millicurie(s)/milligram
        arithmetic mean (standard deviation)
    558 ( 149 )
    531 ( 118 )
    No statistical analyses for this end point

    Secondary: Intraoperative consumption of Remifentanil

    		 Close Top of page
    End point title
    		 Intraoperative consumption of Remifentanil
    End point description
    End point type
    Secondary
    End point timeframe
    From start til end of the anesthesia
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: millicurie(s)/milligram
        arithmetic mean (standard deviation)
    2.15 ( 0.70 )
    2.01 ( 0.57 )
    No statistical analyses for this end point

    Secondary: Length of stay in the PACU

    		 Close Top of page
    End point title
    		 Length of stay in the PACU
    End point description
    End point type
    Secondary
    End point timeframe
    Time of arrival until the patients were ready for discharge
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: minute
        arithmetic mean (standard deviation)
    207 ( 57 )
    218 ( 76 )
    No statistical analyses for this end point

    Secondary: Frequency of vomiting

    		 Close Top of page
    End point title
    		 Frequency of vomiting
    End point description
    Number og patients vomiting postoperative in the PACU
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: Number
    0
    0
    No statistical analyses for this end point

    Secondary: Patient satisfaction (NRS 0–10)

    		 Close Top of page
    End point title
    		 Patient satisfaction (NRS 0–10)
    End point description
    End point type
    Secondary
    End point timeframe
    Patient satisfaction (NRS 0–10)
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    24
    25
    Units: Number
        arithmetic mean (inter-quartile range (Q1-Q3))
    10 (9 to 10)
    9 (8 to 10)
    No statistical analyses for this end point

    Secondary: Ondansetron mg

    		 Close Top of page
    End point title
    		 Ondansetron mg
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    25
    24
    Units: millicurie(s)/milligram
    number (not applicable)
        0 mg
    24
    22
        2 mg
    0
    1
        4 mg
    1
    1
    No statistical analyses for this end point

    Secondary: Droperidol mg

    		 Close Top of page
    End point title
    		 Droperidol mg
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    25
    24
    Units: millicurie(s)/milligram
    number (not applicable)
        0 mg
    25
    22
        0.625 mg
    0
    2
    No statistical analyses for this end point

    Secondary: Postoperative PONV score

    		 Close Top of page
    End point title
    		 Postoperative PONV score
    End point description
    End point type
    Secondary
    End point timeframe
    The first 3 hours in the PACU
    End point values
    		 Active IPB Placebo IPB
    Number of subjects analysed
    25
    24
    Units: number
    number (not applicable)
        None
    24
    22
        Mild
    0
    1
        Moderate
    1
    1
        Severe
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From anesthesia until discharge from the ambulatory surgery department
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Active IPB group
    Reporting group description
    		 -

    Reporting group title
    Placebo IPB group
    Reporting group description
    		 -

    Serious adverse events
    		 Active IPB group Placebo IPB group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (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
    		 Active IPB group Placebo IPB group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (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: The were no adverse events reported in this trial, neither serious nor non-serious. The Good Clinical Practice Unit at Aalborg and Aarhus University Hospitals monitored the trial and confirmed this.

    More information

    		 Close Top of page

    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/38050149
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 09 14:58:40 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA