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    Clinical Trial Results:
    Opioid free anesthesia in total hip arthroplasty. A randomized, controlled and triple-blind clinical trial.

    Summary
    EudraCT number
    		 2021-003703-18
    Trial protocol
    		 FR  
    Global end of trial date
    02 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2023
    First version publication date
    06 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2021/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05072704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CMC Ambroise Paré
    Sponsor organisation address
    27 boulevard Victor Hugo, Neuilly-sur-Seine, France, 92200
    Public contact
    Service Recherche Clinique, CMC Ambroise Paré, +33 146415079, recherche@clinique-a-pare.fr
    Scientific contact
    Service Recherche Clinique, CMC Ambroise Paré, +33 146415079, recherche@clinique-a-pare.fr
    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
    30 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the benefit of OFA strategy with dexmedetomidine infusion in postoperative analgesia defined by the oxycodone consumption in the first 24 hours after outpatient total hip arthroplasty.
    Protection of trial subjects
    This clinical trial was approved by a Committee for Protection of Human Subjects (CPP Sud Est V - 21-PARE-01 N°SI RIPH 2G : 21.01512) and the french national agency for medicines and health products safety (ANSM MEDAECNAT-2021-07-0023_2021-003703-18). The trial was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice. Prior to inclusion, written informed consent was obtained from all subjects after a thorough oral and written participant information had been given.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2022
    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
    France: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    52
    From 65 to 84 years
    27
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included from February 2022 to February 2023. Patients scheduled for outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask were informed of the study protocol during the anesthesia consultation. They were included on the day of the surgery during preanesthesia visit.

    Pre-assignment
    Screening details
    		 Exclusion criteria : refusal to participate, age < 18 years, hip revision surgery, heart rate < 60 bpm, chronic pain syndrom requiring preoperative morphine use (class 3), contraindications to one or more medications of the protocol, contraindication to laryngeal mask

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control Group
    Arm description
    		 Usual anesthesia strategy with opioids (sufentanil)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pre-operative injection of sufentanil 10µg in 2ml of normal saline on induction of anesthesia + per-operative injection of sufentanil 5µg in 1ml of normal saline during the surgery if needed.

    Arm title
    		 OFA Group
    Arm description
    		 Opioid-free anesthesia strategy: using dexmedetomidine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Pre-operative infusion of dexmedetomidine 1µg/kg in 100ml of normal saline before surgery + per-operative infusion of dexmedetomidine 0.4 µg/kg in 100ml of normal saline during the surgery if needed.

    Number of subjects in period 1
    		Control Group OFA Group
    Started
    40
    40
    Completed
    40
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Usual anesthesia strategy with opioids (sufentanil)

    Reporting group title
    OFA Group
    Reporting group description
    		 Opioid-free anesthesia strategy: using dexmedetomidine

    Reporting group values
    		 Control Group OFA Group Total
    Number of subjects
    		 40 40 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 31 21 52
        From 65-84 years
    		 8 19 27
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.5 ( 8.3 ) 60.3 ( 12.6 ) -
    Gender categorical
    Units: Subjects
        Male
    		 24 31 55
        Female
    		 16 9 25
    Surgical approach to the hip
    Units: Subjects
        Anterior
    		 11 17 28
        Posterolateral
    		 29 23 52
    Need for an additional injection (sufentanil or dexmedetomidine) during surgery
    Units: Subjects
        Yes
    		 16 16 32
        No
    		 24 24 48
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 26.5 ( 3.2 ) 24.8 ( 3.3 ) -
    Surgery time
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 50 (45 to 60) 50 (45 to 56) -
    Propofol
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    		 1200 (1150 to 1525) 1235 (1015 to 1425) -

    End points

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    End points reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Usual anesthesia strategy with opioids (sufentanil)

    Reporting group title
    OFA Group
    Reporting group description
    		 Opioid-free anesthesia strategy: using dexmedetomidine

    Primary: Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery

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    End point title
    		 Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
    End point description
    Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
    End point type
    Primary
    End point timeframe
    From the arrival time in post-anesthesia care unit (PACU) to 24h after surgery
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40
    40
    Units: milligram(s)
    median (inter-quartile range (Q1-Q3))
        Cumulative OME at H24, mg
    12 (0 to 29)
    16 (0 to 30)
    Statistical analysis title
    		 Cumulative OME at 24h
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Analgesia in post-anesthesia care unit (PACU)

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    End point title
    		 Analgesia in post-anesthesia care unit (PACU)
    End point description
    Total amount of oxycodone (mg) administered in PACU
    End point type
    Secondary
    End point timeframe
    PACU stay
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40
    40
    Units: milligram(s)
    median (inter-quartile range (Q1-Q3))
        Cumulative OME in PACU, mg
    7 (0 to 18)
    6 (0 to 12)
    Statistical analysis title
    		 Cumulative OME in PACU
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Postoperative pain at rest

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    End point title
    		 Postoperative pain at rest
    End point description
    Postoperative pain at rest (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)
    End point type
    Secondary
    End point timeframe
    24h after surgery
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40 [1]
    40 [2]
    Units: No unit
    median (inter-quartile range (Q1-Q3))
        VRS at H0
    2.0 (0.0 to 6.0)
    1.0 (0.0 to 5.0)
        VRSmax during PACU stay
    5.0 (3.0 to 7.0)
    5.0 (2.2 to 5.0)
        VRS at discharge from the PACU
    2.0 (1.0 to 3.0)
    2.0 (0.0 to 3.0)
        VRS at H6
    0.0 (0.0 to 0.8)
    0.0 (0.0 to 1.0)
        VRS at H12
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 4.0)
        VRS at H18
    2.0 (1.0 to 3.0)
    2.5 (2.0 to 4.0)
        VRS at H24
    2.0 (1.0 to 3.0)
    2.0 (2.0 to 3.0)
    Notes
    [1] - 1 missing data in Control group for VRS at H0
    [2] - OFA Group : 2 missing data for VRS at H0 ; 1 missing data for VRS at discharge from the PACU
    Statistical analysis title
    		 VRS at H0
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRSmax during PACU stay
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at discharge from the PACU
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at H6
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at H12
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at H18
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at H24
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Postoperative pain at walk

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    End point title
    		 Postoperative pain at walk
    End point description
    Postoperative pain at mobilization (numeric rating scale ranging from 0 to 10 : 0 = no pain; 10 = worst imaginable pain)
    End point type
    Secondary
    End point timeframe
    Days 0 and 1
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40
    40
    Units: No unit
    median (inter-quartile range (Q1-Q3))
        VRS at Day0 (operating day)
    1.0 (0.0 to 3.0)
    2.0 (0.0 to 3.0)
        VRS at Day1
    2.0 (1.0 to 3.0)
    3.0 (1.2 to 3.8)
    Statistical analysis title
    		 VRS at Day0 (Operating day)
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 VRS at Day1
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Length of stay in post-anesthesia care unit (PACU)

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    End point title
    		 Length of stay in post-anesthesia care unit (PACU)
    End point description
    Duration of PACU stay (min)
    End point type
    Secondary
    End point timeframe
    Postoperative period : from the arrival in PACU to the discharge
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40
    40
    Units: minute
    median (inter-quartile range (Q1-Q3))
        PACU time, min
    92 (82 to 109)
    101 (81 to 127)
    Statistical analysis title
    		 Duration of PACU stay (min)
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time to recover the ability to walk

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    End point title
    		 Time to recover the ability to walk
    End point description
    Duration for recovery the ability to walk (min)
    End point type
    Secondary
    End point timeframe
    Postoperative period : from the arrival in PACU to the first successful walk test
    End point values
    		 Control Group OFA Group
    Number of subjects analysed
    40
    40
    Units: minute
    arithmetic mean (standard deviation)
        Walking recovery time, min
    240 ( 46 )
    225 ( 59 )
    Statistical analysis title
    		 Duration for recovery the ability to walk (min)
    Comparison groups
    Control Group v OFA Group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of inclusion to the end of the study for the subject
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Usual anesthesia strategy with opioids (sufentanil)

    Reporting group title
    OFA Group
    Reporting group description
    		 Opioid-free anesthesia strategy: using dexmedetomidine

    Serious adverse events
    		 Control Group OFA Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Severe hypotension
    Additional description: systolic arterial pressure < 70 mmHg
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Control Group OFA Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 40 (95.00%)
    32 / 40 (80.00%)
    Injury, poisoning and procedural complications
    Bleeding
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    Laryngospasm
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nausea and/or vomiting
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    Vascular disorders
    Hypotension
    Additional description: systolic arterial pressure < 90 mmHg or requiring treatment
         subjects affected / exposed
    19 / 40 (47.50%)
    13 / 40 (32.50%)
         occurrences all number
    27
    20
    Hypertension
    Additional description: systolic arterial pressure > 160 mmHg or requiring treatment
         subjects affected / exposed
    21 / 40 (52.50%)
    20 / 40 (50.00%)
         occurrences all number
    21
    21
    Cardiac disorders
    Bradycardia
    Additional description: heart rate < 50 bpm or requiring treatment
         subjects affected / exposed
    6 / 40 (15.00%)
    9 / 40 (22.50%)
         occurrences all number
    6
    12
    Surgical and medical procedures
    Prolonged hospitalization
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    8 / 40 (20.00%)
    2 / 40 (5.00%)
         occurrences all number
    10
    2
    Renal and urinary disorders
    Micturition disorder
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Drowsiness
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Low back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1

    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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    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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