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    Clinical Trial Results:
    A study to Investigate the Effect of Intraperitoneal Levobupivacaine on Post Operative Laparoscopic Pain

    Summary
    EudraCT number
    		 2009-011207-23
    Trial protocol
    		 GB  
    Global end of trial date
    27 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2019
    First version publication date
    11 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R0831
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull and East Yorkshire Hospitals NHS Trust
    Sponsor organisation address
    Anlaby Road , Hull, United Kingdom, HU3 2JZ
    Public contact
    Research & Development Department , Hull and East Yorkshire Hospitals NHS Trust, 044 01482461903, research.development@hey.nhs.uk
    Scientific contact
    Women and Children's Hospital , Hull and East Yorkshire Hospitals NHS Trust, 044 01482461271, research.development@hey.nhs.uk
    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
    19 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principle research question is whether leaving a local anaesthetic solution in the abdomen after keyhole surgery improves pain relief.
    Protection of trial subjects
    Nothing specific to this trial, all participants received general anaesthesia as per normal surgical practice.
    Background therapy
    		 General anaesthetic as per Trust standard induction process.
    Evidence for comparator
    		 The comparator in this study was sodium chloride. This was the choice of comparator due to the minimal risk of any adverse reactions or complications.
    Actual start date of recruitment
    09 Jun 2011
    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: 109
    Worldwide total number of subjects
    109
    EEA total number of subjects
    109
    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)
    103
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited between 09.06.11 and 27.07.15. All patients were recruited from surgical/gynaecological clinics within the Hull and East Yorkshire Hospitals NHS Trust.

    Pre-assignment
    Screening details
    		 Patients attended for minor laparoscopic gynaecological procedure. They had a BMI of less than 35 who weighed more than 50kg with an ASA less than or equal to 2. Any patient no fulfilling these criteria were excluded from the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer
    Blinding implementation details
    IMP and comparator dispensed in identical packaging from pharmacy directly to the anaesthetist who administered this.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levobupvicaine
    Arm description
    		 Patients received 40mls of 0.25% levobupivacaine instilled into the peritoneal cavity at the end of the procedure and left in situ.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levobupivicaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Levobupivicaine 0.25% 40mls

    Investigational medicinal product name
    Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Sodium Chloride 0.9% 40mls

    Arm title
    		 Comparator
    Arm description
    		 0.9% normal saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    40 mls administered viaintraperitoneal route

    Number of subjects in period 1
    		Levobupvicaine Comparator
    Started
    54
    55
    Completed
    50
    51
    Not completed
    4
    4
         Consent withdrawn by subject
    -
    1
         Patient underwent spinal surgery
    -
    2
         Underwent spinal surgery
    3
    -
         Surgery cancelled
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 109 109
    Age categorical
    Subjects were all female aged between 18- 80 years of age.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 103 103
        85 years and over
    		 6 6
    Gender categorical
    All patients were female
    Units: Subjects
        Female
    		 109 109
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Levobupvicaine
    Reporting group description
    		 Patients received 40mls of 0.25% levobupivacaine instilled into the peritoneal cavity at the end of the procedure and left in situ.

    Reporting group title
    Comparator
    Reporting group description
    		 0.9% normal saline

    Primary: Pain

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    End point title
    		 Pain
    End point description
    Each subject was asked to record a score for pain at the wound sites, pelvis and shoulder tip at each of the time points. A record was kept of anaesthesia administered and of analgesia administered postoperatively whilst still in hospital and analgesia taken after discharge until the completion of their four-day numerical scale completion.
    End point type
    Primary
    End point timeframe
    Assessment of post-operative pain at 3 hours, 8 hours, 24 hours and 96 hours.
    End point values
    		 Levobupvicaine Comparator
    Number of subjects analysed
    50
    52
    Units: 1 to 10
        number (not applicable)
    50
    52
    Statistical analysis title
    		 Should tip pain 3 hours post surgery
    Statistical analysis description
    A correlation will be sought between the two groups - pain scores (at the various sites and time points)
    Comparison groups
    Levobupvicaine v Comparator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Shoulder tip pain 3 hour post surgery
    Statistical analysis title
    		 Wound pain 8 hour post surgery
    Comparison groups
    Comparator v Levobupvicaine
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.045
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Wound pain 4 day post surgery
    Comparison groups
    Levobupvicaine v Comparator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of consent to 30 days post intervention.
    Adverse event reporting additional description
    Pain scores and diary completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Comparator
    Reporting group description
    		 Patients who received 0.9% saline

    Reporting group title
    Levobuvicaine
    Reporting group description
    		 Received IMP

    Serious adverse events
    		 Comparator Levobuvicaine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Irritable bowel syndrome
    Additional description: Event was not related to the study treatment.
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
    Additional description: Event occurred during surgery but before IMP was administrated.
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 50 (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: 2%
    Non-serious adverse events
    		 Comparator Levobuvicaine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 50 (2.00%)
    Skin and subcutaneous tissue disorders
    Redness and itching
    Additional description: Redness and itching at the cannula site post morphine administration prior to IMP administration.
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2009
    Details unknown, the amendment was pre-approval.
    01 Mar 2011
    Text regarding the target patient number was inserted. Clarification of the solution to be used. Clarification of the randomisation and dispensing method.
    22 Jan 2013
    No documents changed. Temporary halt while replacement PI found.
    30 Jul 2013
    Change of PI from Professor Killick to Mr Phillips.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Jan 2013
    PI left Trust
    30 Jul 2013

    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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