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    Clinical Trial Results:
    Spinal or epidural fentanyl or sufentanil for labour pain in early phase of the labour

    Summary
    EudraCT number
    		 2016-000486-23
    Trial protocol
    		 FI  
    Global end of trial date
    29 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2021
    First version publication date
    24 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    #01/01.02.2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02885350
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinki University central hopsital/Women's hospital
    Sponsor organisation address
    Haartmaninkatu 2, Helsinki, Finland, 00780
    Public contact
    Women's hospital/Naistenklinikka/dept of anesthesia, Helsinki University Central Hospital, 358 504271850, antti.vaananen@hus.fi
    Scientific contact
    Women's hospital/Naistenklinikka/dept of anesthesia, Helsinki University Central Hospital, 358 504271850, antti.vaananen@hus.fi
    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
    26 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Alleviation of labour pain at 20 minutes after intervention
    Protection of trial subjects
    Intervention performed by non-blinded anesthesiologist who did not participate in the collection of the data.
    Background therapy
    		 Non medical alleviation of the labour pain Nitrous oxide
    Evidence for comparator
    		 All interventions and comparators have been used in previous studies to alleviate labour pain.
    Actual start date of recruitment
    16 Sep 2016
    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
    Finland: 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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Parturients fulfilling the inclusion criteria were recruited from 16th Sep 2016 until completion of the trial 29th Nov 2017 from the Helsinki university central hospital.

    Pre-assignment
    Screening details
    		 Parturients were informed about the trial beforehand in writing and by oral information. Upon final inclusion into the study they were to have maximum pain during contraction at 80 mm and not received other opioid medication within the prior 120 minutes.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    The study subject, data collector (present for the first 30 minutes in the delivery suite) and caretaking midwife were all blinded. Also the data analysis was carried out blinded for the fetal heart rate analysis.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Spinal fentanyl
    Arm description
    		 Combined spinal epidural analgesia where a dose of 20 micrograms of fentanyl was given into intrathecal space
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fentanyl citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    20 micrograms given in a total volume of 2 ml (dilution with saline)

    Arm title
    		 Epidural fentanyl
    Arm description
    		 Normal epidural catheter placed and 100 micrograms of fentanyl citrate given epidurally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fentanyl citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Epidural use
    Dosage and administration details
    100 micrograms given in a total volume of 7 ml (dilution with saline)

    Arm title
    		 Spinal sufentanil
    Arm description
    		 5 micrograms of sufentanil was given intrathecally by using combined spinal epidural technique
    Arm type
    		 Active comparator

    Investigational medicinal product name
    sufentanil citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    5 micrograms in a volume of 2 ml (diluted) with saline was given intrathecally

    Arm title
    		 Epidural sufentanil
    Arm description
    		 20 micrograms of sufentanil given into epidural space
    Arm type
    		 Experimental

    Investigational medicinal product name
    sufentanil citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Epidural use
    Dosage and administration details
    20 micrograms in a volume of 7 ml (diluted) with saline was given intrathecally

    Number of subjects in period 1
    		Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Started
    20
    20
    20
    20
    Completed
    20
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Spinal fentanyl
    Reporting group description
    		 Combined spinal epidural analgesia where a dose of 20 micrograms of fentanyl was given into intrathecal space

    Reporting group title
    Epidural fentanyl
    Reporting group description
    		 Normal epidural catheter placed and 100 micrograms of fentanyl citrate given epidurally

    Reporting group title
    Spinal sufentanil
    Reporting group description
    		 5 micrograms of sufentanil was given intrathecally by using combined spinal epidural technique

    Reporting group title
    Epidural sufentanil
    Reporting group description
    		 20 micrograms of sufentanil given into epidural space

    Reporting group values
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil Total
    Number of subjects
    		 20 20 20 20 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20 20 20 80
    Gender categorical
    Units: Subjects
        Female
    		 20 20 20 20 80
        Male
    		 0 0 0 0 0
    Maximum pain during contraction
    Pain on 0-100 mm VAS scale during contraction at baseline
    Units: mm
        geometric mean (standard deviation)
    		 84.3 ± 11.7 87.2 ± 8.9 86.2 ± 8.3 87.5 ± 11.3 -
    Subject analysis sets

    Subject analysis set title
    Spinal fentanyl
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The twenty parturients who received the 20 microgram spinal fentanyl dose

    Subject analysis set title
    Epidural fentanyl
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the epidural 100 microgram fentanyl dose

    Subject analysis set title
    Spinal sufentanil
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the 5 microgram intrathecal sufentanil dose

    Subject analysis set title
    Epidural sufentanil
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the 20 microgram epidural sufentanil dose

    Subject analysis sets values
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Number of subjects
    20
    20
    20
    20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    20
    20
    20
    20
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    20
    20
    20
    20
        Male
    0
    0
    0
    0
    Maximum pain during contraction
    Pain on 0-100 mm VAS scale during contraction at baseline
    Units: mm
        geometric mean (standard deviation)
    24.7 ± 30.9
    51.5 ± 25.2
    19.1 ± 25.7
    45.4 ± 29.0

    End points

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    End points reporting groups
    Reporting group title
    Spinal fentanyl
    Reporting group description
    		 Combined spinal epidural analgesia where a dose of 20 micrograms of fentanyl was given into intrathecal space

    Reporting group title
    Epidural fentanyl
    Reporting group description
    		 Normal epidural catheter placed and 100 micrograms of fentanyl citrate given epidurally

    Reporting group title
    Spinal sufentanil
    Reporting group description
    		 5 micrograms of sufentanil was given intrathecally by using combined spinal epidural technique

    Reporting group title
    Epidural sufentanil
    Reporting group description
    		 20 micrograms of sufentanil given into epidural space

    Subject analysis set title
    Spinal fentanyl
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The twenty parturients who received the 20 microgram spinal fentanyl dose

    Subject analysis set title
    Epidural fentanyl
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the epidural 100 microgram fentanyl dose

    Subject analysis set title
    Spinal sufentanil
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the 5 microgram intrathecal sufentanil dose

    Subject analysis set title
    Epidural sufentanil
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The 20 parturients who received the 20 microgram epidural sufentanil dose

    Primary: Reduction of maximum pain during contraction at 20 minutes on 0-100 mm VAS scale

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    End point title
    		 Reduction of maximum pain during contraction at 20 minutes on 0-100 mm VAS scale
    End point description
    at 20 minutes after the investigational drug or comparator administration
    End point type
    Primary
    End point timeframe
    20 minutes
    End point values
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Number of subjects analysed
    20
    20
    20
    20
    Units: mm
        geometric mean (confidence interval 95%)
    60 (46 to 74)
    36 (24 to 47)
    67 (54 to 81)
    42 (30 to 55)
    Attachments
    		 VAS during contraction
    Statistical analysis title
    		 Difference between spinal and epidural sufentanil
    Comparison groups
    Spinal sufentanil v Epidural sufentanil
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
    Statistical analysis title
    		 Difference between spinal and epidural fentanyl
    Comparison groups
    Spinal fentanyl v Epidural fentanyl
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Duration of analgesia until the next epidural analgesia dose

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    End point title
    		 Duration of analgesia until the next epidural analgesia dose
    End point description
    The duration of time in minutes until the parturient receives a new epidural dose
    End point type
    Secondary
    End point timeframe
    Within 5 hours
    End point values
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Number of subjects analysed
    20
    20
    20
    20
    Units: minutes
        geometric mean (confidence interval 95%)
    177 (121 to 234)
    112 (80 to 143)
    151 (111 to 192)
    130 (93 to 168)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 minutes after the intervention
    Adverse event reporting additional description
    PRuritus and nausea interviewed for 30 minutes, fetal heart rate monitored continuously until delivery as per institutional protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Spinal fentanyl
    Reporting group description
    		 Combined spinal epidural analgesia where a dose of 20 micrograms of fentanyl was given into intrathecal space

    Reporting group title
    Epidural fentanyl
    Reporting group description
    		 Normal epidural catheter placed and 100 micrograms of fentanyl citrate given epidurally

    Reporting group title
    Spinal sufentanil
    Reporting group description
    		 5 micrograms of sufentanil was given intrathecally by using combined spinal epidural technique

    Reporting group title
    Epidural sufentanil
    Reporting group description
    		 20 micrograms of sufentanil given into epidural space

    Serious adverse events
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Spinal fentanyl Epidural fentanyl Spinal sufentanil Epidural sufentanil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 20 (90.00%)
    8 / 20 (40.00%)
    12 / 20 (60.00%)
    8 / 20 (40.00%)
    Pregnancy, puerperium and perinatal conditions
    Foetal heart rate abnormal
    Additional description: Changes in foetal heart rate
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    6 / 20 (30.00%)
    4 / 20 (20.00%)
         occurrences all number
    3
    3
    6
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    18 / 20 (90.00%)
    8 / 20 (40.00%)
    12 / 20 (60.00%)
    8 / 20 (40.00%)
         occurrences all number
    18
    8
    12
    8

    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/31286476
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