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    Clinical Trial Results:
    The effects of sufentanil or morphine added to hyperbaric bupivacaine in spinal anaesthesia for elective caesarean section.

    Summary
    EudraCT number
    		 2017-001430-25
    Trial protocol
    		 ES  
    Global end of trial date
    16 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2021
    First version publication date
    26 Mar 2021
    Other versions
    Summary report(s)
    		 Results report

    Trial information

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    Trial identification
    Sponsor protocol code
    FPS-CES-2017-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03386630
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Pública Andaluza Progreso y Salud
    Sponsor organisation address
    Parque Científico y Tecnológico Cartuja, Avda. Américo Vespucio, 15 · Edificio S-2 · 41092 Sevilla, Seville, Spain, 41092
    Public contact
    Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
    Scientific contact
    Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 0034 955040450, gestionensayosclinicos.fps@juntadeandalucia.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
    16 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the postoperative pain in caesarean section with hyperbaric bupivacaine 0.5% added to sufentanil (5mcg) or morphine (0.1mg).
    Protection of trial subjects
    This study has been designed in accordance with the ethical principles for medical research involving human subjects promulgated in the Declaration of Helsinki of the World Medical Association (64th General Assembly, Fortaleza, Brazil, October 2013) and will be conducted in accordance with the applicable health standards, ethical and good practice standards applicable following the recommendations of the Spanish Ministry of Health on clinical trials, being a Low Intervention Level Clinical Trial, in accordance with Royal Decree 1090/2015, of 4 December, which regulates clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish register of Clinical Studies.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2018
    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: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 - Patients at least 18 years of age and 36 weeks gestation. - Patients scheduled for non-urgent caesarean section. - Patients classified in the American Society of Anaesthesiologists (ASA) physical status as grade I-II, and without significant foetal pathological conditions. - Patients who sign the informed consent form.

    Pre-assignment
    Screening details
    		 - Patients at least 18 years of age and 36 weeks gestation. - Patients scheduled for non-urgent caesarean section. - Patients classified in the American Society of Anaesthesiologists (ASA) physical status as grade I-II, and without significant foetal pathological conditions. - Patients who sign the informed consent form.

    Period 1
    Period 1 title
    Recruitment and follow-up
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sufentanil
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    5 micrograms/ml

    Arm title
    		 Morphine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    0,01 mg

    Number of subjects in period 1
    		Sufentanil Morphine
    Started
    29
    28
    Completed
    29
    28
    Period 2
    Period 2 title
    Data analysis
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sufentanil
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    5 micrograms/ml

    Arm title
    		 Morphine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    0,01 mg

    Number of subjects in period 2
    		Sufentanil Morphine
    Started
    29
    28
    Completed
    29
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sufentanil
    Reporting group description
    		 -

    Reporting group title
    Morphine
    Reporting group description
    		 -

    Reporting group values
    		 Sufentanil Morphine Total
    Number of subjects
    		 29 28 57
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 28 57
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.14 ( 5.21 ) 31.39 ( 4.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 28 57
        Male
    		 0 0 0
    Level of obesity
    Units: Subjects
        No obesidad
    		 14 14 28
        Obesidad grado I
    		 8 11 19
        Obesidad grado II
    		 7 3 10
    ASA
    Units: Subjects
        ASA 1
    		 0 0 0
        ASA 2
    		 29 28 57
        ASA 3
    		 0 0 0
        ASA 4
    		 0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 160.83 ( 5.80 ) 161.39 ( 4.41 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.52 ( 13.31 ) 77.18 ( 11.66 ) -
    IMC
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 31.01 ( 4.54 ) 29.52 ( 4.04 ) -
    number of gestation weeks
    Units: weeks
        arithmetic mean (standard deviation)
    		 38.48 ( 0.82 ) 38.71 ( 0.76 ) -

    End points

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

    Reporting group title
    Morphine
    Reporting group description
    		 -
    Reporting group title
    Sufentanil
    Reporting group description
    		 -

    Reporting group title
    Morphine
    Reporting group description
    		 -

    Primary: Time of onset of pain

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    End point title
    		 Time of onset of pain [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not all the information consulted in this section is available. However, the report on the results, which refers to the statistical analysis carried out, is attached.
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No pain
    1
    3
        0-2 hours
    0
    7
        2-4 hours
    4
    10
        4-6 hours
    13
    0
        6-8
    5
    2
        8-10
    3
    2
        10-12
    3
    2
        18-20
    0
    2
    No statistical analyses for this end point

    Primary: Time of application for the first bolus PCA

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    End point title
    		 Time of application for the first bolus PCA [2]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Not all the information consulted in this section is available. However, the report on the results, which refers to the statistical analysis carried out, is attached.
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No bolus
    2
    4
        0-2 hours
    0
    6
        2-4 hours
    4
    4
        4-6 hours
    9
    2
        6-8 hours
    7
    0
        8-10 hours
    3
    3
        10-12 hours
    3
    0
        12-14 hours
    1
    3
        14-16 hours
    0
    1
        16-18 hours
    0
    0
        18-20 hours
    0
    2
        20-22 hours
    0
    3
        22-24 hours
    0
    0
    No statistical analyses for this end point

    Secondary: Reason for indication for caesarean section

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    End point title
    		 Reason for indication for caesarean section
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        Transverse
    2
    0
        Podalic
    6
    7
        Breech
    7
    9
        Previous caesarean section
    18
    10
        DPC
    0
    1
        Placenta praevia
    2
    1
    No statistical analyses for this end point

    Secondary: Surgical time

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    End point title
    		 Surgical time
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Minutes
        arithmetic mean (standard deviation)
    51.90 ( 14.17 )
    47.86 ( 12.18 )
    No statistical analyses for this end point

    Secondary: EVA Skin incision

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    End point title
    		 EVA Skin incision
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No pain
    29
    26
        Mild pain
    0
    2
        Moderate pain
    0
    0
        Severe pain
    0
    0
    No statistical analyses for this end point

    Secondary: EVA Uterine incision and tearing

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    End point title
    		 EVA Uterine incision and tearing
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No pain
    27
    21
        Mild pain
    2
    7
        Moderate pain
    0
    0
        Severe pain
    0
    0
    No statistical analyses for this end point

    Secondary: EVA Utero-peritoneal manipulation

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    End point title
    		 EVA Utero-peritoneal manipulation
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No pain
    27
    20
        Mild pain
    2
    7
        Moderate oain
    0
    1
        Severe pain
    0
    0
    No statistical analyses for this end point

    Secondary: EVA Abdominal wall and skin closure

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    End point title
    		 EVA Abdominal wall and skin closure
    End point description
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Sufentanil Morphine
    Number of subjects analysed
    29
    28
    Units: Participants
        No pain
    27
    19
        Mild pain
    2
    7
        Moderate pain
    0
    2
        Severe pain
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the inclusion of the first patient to the last visit of the last patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not Known
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Both groups
    Reporting group description
    		 -

    Serious adverse events
    		 Both groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Both groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 57 (43.86%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    8
    Vomiting
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Itching
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2018
    Change of trial site due to change of principal investigator's place of work.
    18 Jul 2018
    Due to the logistics of the research team during the performance of the caesarean section procedure (at which time certain parameters of the study are assessed), it is impossible to record certain secondary variables during the surgical procedure. Likewise, during the evaluation of recovery, variables were initially described that do not provide valuable information for the purpose of the study in comparison with the cost of recording them. In any case, none of the variables eliminated (PH of the umbilical cord, onset of sitting and the patient's ability to stand upright) are in line with the main objective of the clinical trial, based on the analysis of pain, so they will be eliminated from the protocol and the data collection notebook, thus avoiding non-compliance with the protocol as not all the variables described therein are being collected. As a consequence, the secondary objectives in which these variables were analysed are also eliminated.
    16 May 2019
    Due to the logistics of the research team during the performance of the caesarean section procedure (at which time certain parameters of the study are assessed), it is impossible to record certain secondary variables during the surgical procedure. Likewise, during the evaluation of recovery, variables were initially described that do not provide valuable information for the purpose of the study in comparison with the cost of recording them. In any case, none of the variables eliminated (PH of the umbilical cord, onset of sitting and the patient's ability to stand upright) are in line with the main objective of the clinical trial, based on the analysis of pain, so they will be eliminated from the protocol and the data collection notebook, thus avoiding non-compliance with the protocol by not recording all the variables described therein.
    16 May 2019
    The specific dates given will be changed to adapt them to the actual situation, starting from the trial authorisation date, which was also later than planned. The adaptation of the chronology allows us to have a more up-to-date view of the trial and to submit for authorisation the extension of the timeframe for recruitment of trial participants by 5 months.

    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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