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    Clinical Trial Results:
    Etude clinique prospective randomisée en double aveugle de phase 4 comparant la durée d'analgésie postopératoire du fentanyl et du sufentanil administrés comme adjuvant en rachianesthésie dans le cadre de césariennes électives.

    Summary
    EudraCT number
    		 2010-023528-25
    Trial protocol
    		 BE  
    Global end of trial date
    05 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2021
    First version publication date
    18 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SUFRACES
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place A. Van Gehuchten, Brussels, Belgium, 1020
    Public contact
    Dr P. Van der Linden, CHU Brugmann, Philippe.VANDERLINDEN@chu-brugmann.be
    Scientific contact
    Dr P. Van der Linden, CHU Brugmann, Philippe.VANDERLINDEN@chu-brugmann.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
    05 Aug 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To delay the first use of morphine after intrathecal anesthesia.
    Protection of trial subjects
    According to standard of care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2009
    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: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    180
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was achieved by the anaesthesiologist in charge of the patient, who explained the day before surgery the possibility of using one of the three different doses of opiates in addition to intrathecal bupivacaine.

    Pre-assignment
    Screening details
    		 409 patients were assessed for eligibility. 180 patients were enrolled in the study (204 had exclusion criteria, 25 refused to participate) and were allocated in the three groups (Fentanyl n=60, Sufentanil 2.5µg n=60, Sufentanil 5µg n=60). Two patients were excluded from the analysis because of spinal anesthesia failure.

    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, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sufentanil 2,5µg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Sufenta
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Sufentanil 2.5ug, intrathecal use. The pharmacist prepared the opioid solutions which were supplied to the Caesarean section theatre in numbered blinded sterile bags. To standardise the injected volumes, sufentanil 2,5 μg (Sufentanil® 5 μg/ml; Janssen-Cilag SA, Beerse, Belgium) and fentanyl 25 μg (Fentanyl® 50 μg/ml; Janssen-Cilag SA) were diluted by the pharmacist with 0,5 ml isotonic saline to obtain 1 ml of study drug, as for sufentanil 5 μg. The anaesthesiologist added 10 mg of hyperbaric bupivacaine (Hyperbaric Marcaine 0,5%®; Astra-Zeneca Inc) for a total volume of 3 ml, to be injected in each enrolled and randomized patient.

    Arm title
    		 Sufentanil 5µg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Sufenta
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Sufentanil 5ug, intrathecal use. The pharmacist prepared the opioid solutions which were supplied to the Caesarean section theatre in numbered blinded sterile bags. To standardise the injected volumes, sufentanil 2,5 μg (Sufentanil® 5 μg/ml; Janssen-Cilag SA, Beerse, Belgium) and fentanyl 25 μg (Fentanyl® 50 μg/ml; Janssen-Cilag SA) were diluted by the pharmacist with 0,5 ml isotonic saline to obtain 1 ml of study drug, as for sufentanil 5 μg. The anaesthesiologist added 10 mg of hyperbaric bupivacaine (Hyperbaric Marcaine 0,5%®; Astra-Zeneca Inc) for a total volume of 3 ml, to be injected in each enrolled and randomized patient.

    Arm title
    		 Fentanyl 25µg
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fentanyl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Fentanyl 25µg, intrathecal use. The pharmacist prepared the opioid solutions which were supplied to the Caesarean section theatre in numbered blinded sterile bags. To standardise the injected volumes, sufentanil 2,5 μg (Sufentanil® 5 μg/ml; Janssen-Cilag SA, Beerse, Belgium) and fentanyl 25 μg (Fentanyl® 50 μg/ml; Janssen-Cilag SA) were diluted by the pharmacist with 0,5 ml isotonic saline to obtain 1 ml of study drug, as for sufentanil 5 μg. The anaesthesiologist added 10 mg of hyperbaric bupivacaine (Hyperbaric Marcaine 0,5%®; Astra-Zeneca Inc) for a total volume of 3 ml, to be injected in each enrolled and randomized patient.

    Number of subjects in period 1
    		Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Started
    60
    60
    60
    Completed
    59
    60
    59
    Not completed
    1
    0
    1
         Spinal anaesthesia failure
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sufentanil 2,5µg
    Reporting group description
    		 -

    Reporting group title
    Sufentanil 5µg
    Reporting group description
    		 -

    Reporting group title
    Fentanyl 25µg
    Reporting group description
    		 -

    Reporting group values
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg Total
    Number of subjects
    		 60 60 60 180
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 60 60 60 180
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 60 60 60 180
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Sufentanil 2,5µg
    Reporting group description
    		 -

    Reporting group title
    Sufentanil 5µg
    Reporting group description
    		 -

    Reporting group title
    Fentanyl 25µg
    Reporting group description
    		 -

    Primary: Effective analgesia duration (PCA)

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    End point title
    		 Effective analgesia duration (PCA)
    End point description
    End point type
    Primary
    End point timeframe
    Time from intrathecal injection to the first morphine request by the patient as recorded by the PCA delivery system.
    End point values
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Number of subjects analysed
    57
    60
    59
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    214 (189 to 251)
    236 (190 to 372)
    187 (151 to 230)
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Continuous variables were tested for normality using the Shapiro–Wilk normality test: the population has a non-gaussian distribution. Continuous variables were compared using a Kruskall–Wallis test to investigate overall differences and then a Mann–Whitney U-test for specific differences between groups. No adjustment for multiple comparisons was made. Categorical variables were compared using chi-squared. Statistical significance was set at p < 0,05. Fentanyl is the control treatment.
    Comparison groups
    Sufentanil 2,5µg v Sufentanil 5µg v Fentanyl 25µg
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Effective analgesia duration (VAS)

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    End point title
    		 Effective analgesia duration (VAS)
    End point description
    End point type
    Primary
    End point timeframe
    Effective analgesia duration determined as the time from intrathecal injection to VAS score superior or equal to 4.
    End point values
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Number of subjects analysed
    59
    60
    59
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    420 (240 to 1200)
    600 (300 to 1440)
    300 (225 to 720)
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Continuous variables were tested for normality using the Shapiro–Wilk normality test: the population has a non-gaussian distribution. Continuous variables were compared using a Kruskall–Wallis test to investigate overall differences and then a Mann–Whitney U-test for specific differences between groups. No adjustment for multiple comparisons was made. Categorical variables were compared using chi-squared. Statistical significance was set at p < 0,05. Fentanyl is the control treatment.
    Comparison groups
    Sufentanil 2,5µg v Sufentanil 5µg v Fentanyl 25µg
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mophine/4h

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    End point title
    		 Mophine/4h
    End point description
    End point type
    Secondary
    End point timeframe
    Number of morphine boluses administered during 4h after the first morphine requirement
    End point values
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Number of subjects analysed
    59
    60
    59
    Units: mg
        median (inter-quartile range (Q1-Q3))
    6 (4 to 9)
    6 (2 to 10)
    9 (5 to 13)
    No statistical analyses for this end point

    Secondary: Morphine/24h

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    End point title
    		 Morphine/24h
    End point description
    End point type
    Secondary
    End point timeframe
    Total morphine consumption during 24h after the spinal injection
    End point values
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Number of subjects analysed
    59
    60
    59
    Units: mg
        median (inter-quartile range (Q1-Q3))
    18 (9 to 28)
    15 (5 to 30)
    22 (14 to 31)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clinical practice
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Sufentanil 2,5µg
    Reporting group description
    		 -

    Reporting group title
    Sufentanil 5µg
    Reporting group description
    		 -

    Reporting group title
    Fentanyl 25µg
    Reporting group description
    		 -

    Serious adverse events
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sufentanil 2,5µg Sufentanil 5µg Fentanyl 25µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 59 (37.29%)
    22 / 60 (36.67%)
    20 / 59 (33.90%)
    Cardiac disorders
    Hypotension
         subjects affected / exposed
    22 / 59 (37.29%)
    22 / 60 (36.67%)
    20 / 59 (33.90%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Nausea/Vomiting
         subjects affected / exposed
    5 / 59 (8.47%)
    5 / 60 (8.33%)
    7 / 59 (11.86%)
         occurrences all number
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    21 / 59 (35.59%)
    18 / 60 (30.00%)
    13 / 59 (22.03%)
         occurrences all number
    1
    1
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27137756
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