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    Clinical Trial Results:
    Ropivacaine Perineal Infiltration for Postpartum Pain Management in Episiotomy Repair: a Double-blind, Randomised, Placebo-controlled Trial

    Summary
    EudraCT number
    		 2016-002786-62
    Trial protocol
    		 FR  
    Global end of trial date
    04 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2022
    First version publication date
    03 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHD065-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03084549
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Hospitalier Départemental Vendée
    Sponsor organisation address
    Bd Stephane MOREAU, La Roche sur Yon, France, 85925
    Public contact
    Dorion Agnès, Centre Hospitalier Départemental Vendée, +33 251446380, agnes.dorion@ght85.fr
    Scientific contact
    Dr Guillaume DUCARME, Centre Hospitalier Départemental Vendée, guillaume.ducarme@ght85.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
    24 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period.
    Protection of trial subjects
    All adverse events or reactions (except those specified in the protocol), whether expected or unexpected, serious or not, were collected in the eCRF. The follow-up of events or adverse reactions, serious or not, was ensured until resolution or consolidation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 272
    Worldwide total number of subjects
    272
    EEA total number of subjects
    272
    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)
    272
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Inclusion period: 36 months First inclusion: 2017/20/24 Last inclusion: 2020/04/29

    Pre-assignment
    Screening details
    		 Women who had given birth to a singleton foetus in cephalic presentation at 37 weeks of gestation or more, with spontaneous or operative vaginal delivery under epidural anaesthesia and who had received mediolateral episiotomy were eligible for enrolment in the study.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ropivacaine
    Arm description
    		 Eligible women were receive 75 mg of ropivacaine (Fresenius Kabi) in a 20-mL syringe (10-mL of ropivacaine 7.5mg/mL and 10-mL of normal saline)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    N01BB09
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    syringe with 10-mL of ropivacaine 7.5mg/mL and 10-mL of normal saline One injection

    Arm title
    		 Placebo
    Arm description
    		 20 mL of normal saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Chlorure de sodium
    Investigational medicinal product code
    B05XA03
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    20 mL one injection

    Number of subjects in period 1
    		Ropivacaine Placebo
    Started
    135
    137
    immediate postpartum period H12,H24,H48
    135
    137
    day 7 postpartum
    135
    137
    long-term postpartum M3
    135
    137
    long-term postpartum M6
    135
    137
    Completed
    135
    137

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ropivacaine
    Reporting group description
    		 Eligible women were receive 75 mg of ropivacaine (Fresenius Kabi) in a 20-mL syringe (10-mL of ropivacaine 7.5mg/mL and 10-mL of normal saline)

    Reporting group title
    Placebo
    Reporting group description
    		 20 mL of normal saline

    Reporting group values
    		 Ropivacaine Placebo Total
    Number of subjects
    		 135 137 272
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 135 137 272
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.0 ± 4.5 30.3 ± 4.6 -
    Gender categorical
    Units: Subjects
        Female
    		 135 137 272
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Ropivacaine
    Reporting group description
    		 Eligible women were receive 75 mg of ropivacaine (Fresenius Kabi) in a 20-mL syringe (10-mL of ropivacaine 7.5mg/mL and 10-mL of normal saline)

    Reporting group title
    Placebo
    Reporting group description
    		 20 mL of normal saline

    Primary: Perineal pain

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    End point title
    		 Perineal pain
    End point description
    The primary outcome was the analgesic efficacy of ropivacaine at day 7 postpartum (medium term) measured with the numerical pain rating scale (NPRS), exceeding 3/10 in the perineal repair area
    End point type
    Primary
    End point timeframe
    day 7 postpartum
    End point values
    		 Ropivacaine Placebo
    Number of subjects analysed
    114
    115
    Units: number
    39
    35
    Statistical analysis title
    		 Perineal Pain
    Comparison groups
    Ropivacaine v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    data were collected from randomisation to the immediate postpartum period at H48
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Ropivacaine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Ropivacaine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 135 (2.22%)
    4 / 137 (2.92%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Incorrect route of product administration
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Perineal haematoma
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Lactation disorder
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Genital abscess
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 137 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ropivacaine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 135 (85.93%)
    129 / 137 (94.16%)
    Injury, poisoning and procedural complications
    Incision site haematoma
         subjects affected / exposed
    4 / 135 (2.96%)
    1 / 137 (0.73%)
         occurrences all number
    4
    1
    Incision site haemorrhage
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Incision site pain
         subjects affected / exposed
    97 / 135 (71.85%)
    107 / 137 (78.10%)
         occurrences all number
    129
    135
    Postoperative wound complication
         subjects affected / exposed
    3 / 135 (2.22%)
    1 / 137 (0.73%)
         occurrences all number
    3
    1
    Suture related complication
         subjects affected / exposed
    2 / 135 (1.48%)
    1 / 137 (0.73%)
         occurrences all number
    2
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    21 / 135 (15.56%)
    15 / 137 (10.95%)
         occurrences all number
    21
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 137 (2.19%)
         occurrences all number
    1
    3
    Pregnancy, puerperium and perinatal conditions
    Perineal haematoma
         subjects affected / exposed
    8 / 135 (5.93%)
    14 / 137 (10.22%)
         occurrences all number
    8
    14
    Postpartum haemorrhage
         subjects affected / exposed
    15 / 135 (11.11%)
    17 / 137 (12.41%)
         occurrences all number
    15
    17
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 135 (4.44%)
    6 / 137 (4.38%)
         occurrences all number
    6
    6
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    8 / 135 (5.93%)
    11 / 137 (8.03%)
         occurrences all number
    9
    12
    Pyrexia
         subjects affected / exposed
    2 / 135 (1.48%)
    1 / 137 (0.73%)
         occurrences all number
    2
    1
    Oedema
         subjects affected / exposed
    7 / 135 (5.19%)
    7 / 137 (5.11%)
         occurrences all number
    7
    7
    Reproductive system and breast disorders
    Oedema genital
         subjects affected / exposed
    3 / 135 (2.22%)
    8 / 137 (5.84%)
         occurrences all number
    3
    8
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    1 / 135 (0.74%)
    4 / 137 (2.92%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Coccydynia
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 137 (1.46%)
         occurrences all number
    0
    2
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 137 (0.73%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 135 (1.48%)
    1 / 137 (0.73%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2017
    Modification of the dose and administered concentration of Ropivacaine
    21 Mar 2018
    Modification of the labelling of the treatment boxes
    12 Sep 2018
    Modification of AE notification procedure updated consent form (implementation of REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL)
    26 Mar 2019
    extension of study period (+18 months)
    02 Mar 2020
    update Ropivacaine's Summary of Product Characteristics

    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/35876236
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