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    Clinical Trial Results:
    Double blind randomised multicentre study to assess the effect of local anaesthesia during vaginal hysterectomy

    Summary
    EudraCT number
    		 2013-004124-11
    Trial protocol
    		 GB  
    Global end of trial date
    13 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2020
    First version publication date
    27 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    POPPOP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Prof Linda Cardozo, KCH NHS Foundation Trust, 0044 2032993000, linda.cardozo@nhs.net
    Scientific contact
    Prof Linda Cardozo, KCH NHS Foundation Trust, 0044 2032993000, linda.cardozo@nhs.net
    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
    13 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does the injection of local anaesthetic and adrenaline solution into the superficial tissue around the uterine cervix during vaginal hysterectomy reduce post-operative pain?
    Protection of trial subjects
    Participants will be invited from those who have decided to under vaginal hysterectomy with or without concomitant pelvic floor surgery. Both local anaesthetic and adrenaline have been used safely for many years and pose minimal risk to patients. All patients must be able to provide written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2014
    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
    United Kingdom: 153
    Worldwide total number of subjects
    153
    EEA total number of subjects
    153
    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)
    105
    From 65 to 84 years
    46
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place in 5 UK centres between 18 Feb 2015 and 13 Dec 2018 All women booking for a vaginal hysterectomy will be given information about the study at the booking clinic itself. Participation will be discussed when attending the pre-operative clinic.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 153
    Number of subjects completed
    		 153

    Period 1
    Period 1 title
    Overall Trial Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    For safety reasons, the anaesthetist will not be blinded at any point.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bupivacaine with adrenaline
    Arm description
    		 Bupivacaine (2.5mg/ml (0.25%) with adrenaline 1 in 200 000 (5 micrograms per ml) (5micrograms per ml).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivicaine and Adrenaline Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intracervical use
    Dosage and administration details
    Maximum 100 mg total by infiltration.

    Arm title
    		 Placebo
    Arm description
    		 Normal saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infiltration, Intracervical use, Vaginal use
    Dosage and administration details
    40 mls of normal saline was used as the placebo.

    Number of subjects in period 1
    		Bupivacaine with adrenaline Placebo
    Started
    78
    75
    Completed
    74
    70
    Not completed
    4
    5
         Consent withdrawn by subject
    3
    4
         Lost to follow-up
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Bupivacaine with adrenaline
    Reporting group description
    		 Bupivacaine (2.5mg/ml (0.25%) with adrenaline 1 in 200 000 (5 micrograms per ml) (5micrograms per ml).

    Reporting group title
    Placebo
    Reporting group description
    		 Normal saline

    Primary: Post Operative Pain Same Day

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    End point title
    		 Post Operative Pain Same Day
    End point description
    End point type
    Primary
    End point timeframe
    Patient pain score 3-5 hours post operation
    End point values
    		 Bupivacaine with adrenaline Placebo
    Number of subjects analysed
    78
    75
    Units: McGill Pain Score
    78
    75
    Attachments
    		 Independent Samples Test
    Stats Report
    Statistical analysis title
    		 All continuous variables
    Comparison groups
    Bupivacaine with adrenaline v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Null Hypothesis

    Primary: Post Operative Pain Next Day

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    End point title
    		 Post Operative Pain Next Day
    End point description
    End point type
    Primary
    End point timeframe
    24 hours post operation
    End point values
    		 Bupivacaine with adrenaline Placebo
    Number of subjects analysed
    78
    75
    Units: McGill Pain Score
    78
    75
    Statistical analysis title
    		 All continuous variables
    Comparison groups
    Bupivacaine with adrenaline v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to 30 days after IMP dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Bupivacaine with adrenaline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Bupivacaine with adrenaline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 78 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bupivacaine with adrenaline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 78 (8.97%)
    8 / 75 (10.67%)
    Injury, poisoning and procedural complications
    Post operative ileus
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Vaginal bleeding
         subjects affected / exposed
    0 / 78 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    2
    Vaginal discharge
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    cystotomy unintentional
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Urinary retention
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    vaginal soreness
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Vault haematoma
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Went home with catheter
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Generally unwell
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Rectoenterocele recurrent
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Low temperature
    Additional description: Possible UTI
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 78 (1.28%)
    1 / 75 (1.33%)
         occurrences all number
    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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