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    Clinical Trial Results:
    Intraperitoneal atomization of levobupivacaine during gynecological laparoscopic procedures : Impact on pain, opioid use and length of recovery room stay (IPLA).

    Summary
    EudraCT number
    		 2013-000384-87
    Trial protocol
    		 BE  
    Global end of trial date
    13 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2021
    First version publication date
    21 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2013/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    03 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain in patients undergoing gynecological laparoscopic procedures in one-day surgery.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2013
    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
    Belgium: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 27 patients were screened in the period from 01-03-2013 till 13-06-2014. X patients were included, 16 patients were randomised. 16 patients were included and completed the trial. End of trial notification was dated 13-06-2014 (last patient last visit) and submitted to EC and CA 3-12-2018.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. Exclusion Criteria: Less than 18 year old. Weight < 50 kg and > 80 kg. Pregnant. Prisoners Allergic to topical anesthetics (Amides) and Opioids Currently/within the last 30 days prescribed an opiate Chronic pain syndrome

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomization was done using a computer generated randomization list. The person who will analyse the data, and the nurses who will register the outcomes will be blinded from group allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infiltration of portal sites with 0,5% levobupivacaine.
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Chirocaine
    Investigational medicinal product code
    Other name
    levobupivacaine 0.5%
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration, Intraperitoneal use
    Dosage and administration details
    0.1 ml/kg of levobupivacaine for local injection of the portal sites

    Arm title
    		 Additional injection of 0.5% levobupivacaine via a trocar
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chirocaine
    Investigational medicinal product code
    Other name
    levobupivacaine 0.5%
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration, Intraperitoneal use
    Dosage and administration details
    0.1 ml/kg of levobupivacaine for local injection of the portal sites 0.15 ml/kg of levobupivacaine will be injected in peritoneal cavity via a trocar at the beginning of the surgery 0.15 ml/kg of levobupivacaine will be injected in peritoneal cavity via a trocar again, at the end of the surgery

    Arm title
    		 Additional intraperitoneal atomization of levobupivacaine.
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chirocaine
    Investigational medicinal product code
    Other name
    levobupivacaine 0.5%
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intraperitoneal use, Infiltration
    Dosage and administration details
    0.1 ml/kg of levobupivacaine for local injection of the portal sites 0.15 ml/kg following insuflation of the abdomen will be atomized onto each subdiaphragmatic area, onto the surgical dissection site and diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel), using the OptiSpray® surgical spray device 0.15 ml/kg will be atomized again, at the end of the surgery onto the same areas, using the Optispray® surgical spray device

    Number of subjects in period 1
    		Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Started
    6
    4
    6
    Completed
    6
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infiltration of portal sites with 0,5% levobupivacaine.
    Reporting group description
    		 -

    Reporting group title
    Additional injection of 0.5% levobupivacaine via a trocar
    Reporting group description
    		 -

    Reporting group title
    Additional intraperitoneal atomization of levobupivacaine.
    Reporting group description
    		 -

    Reporting group values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine. Total
    Number of subjects
    		 6 4 6 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 4 6 16
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 4 6 16
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Infiltration of portal sites with 0,5% levobupivacaine.
    Reporting group description
    		 -

    Reporting group title
    Additional injection of 0.5% levobupivacaine via a trocar
    Reporting group description
    		 -

    Reporting group title
    Additional intraperitoneal atomization of levobupivacaine.
    Reporting group description
    		 -

    Primary: Post-operative pain intensity during the postoperative stay in the ambulatory surgery unit

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    End point title
    		 Post-operative pain intensity during the postoperative stay in the ambulatory surgery unit [1]
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Primary
    End point timeframe
    Participants will be followed for the duration of hospital stay, an expected average of 1 day.
    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: No statistical analysis available.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: numeric rating scale (0 - 10)
    0
    0
    0
    No statistical analyses for this end point

    Primary: Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting.

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    End point title
    		 Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting. [2]
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Primary
    End point timeframe
    Participants will be followed for the duration of hospital stay, an expected average of 1 day.
    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: No statistical analysis available.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: numeric rating scale (0 - 10
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.

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    End point title
    		 Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Participants will be followed for the duration of hospital stay, an expected average of 1 day.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: Piritramide 0,05 mg/kg
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.

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    End point title
    		 Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Patients will be followed until 24 hours post-operatively.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: numeric rating scale (0-10)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.

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    End point title
    		 Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Patients will be followed until 24 hours post-operatively.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: numeric rating scale (0-10)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Time until discharge from hospital.

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    End point title
    		 Time until discharge from hospital.
    End point description
    Discharge criterion : modified aldrete ≥ 12/14. There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Patients will be followed until an estimated 24 hours post-operatively.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: time
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Time until discharge from recovery room

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    End point title
    		 Time until discharge from recovery room
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Up until discharge from recovery room post-operatively, probably a few hours.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: time
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.

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    End point title
    		 Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.
    End point description
    There were no results, since no analysis was performed due to limited data.
    End point type
    Secondary
    End point timeframe
    Patients will be followed up to 6 hrs post-operatively.
    End point values
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Number of subjects analysed
    6
    4
    6
    Units: Ramsay sedation score (1-6)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Infiltration of portal sites with 0,5% levobupivacaine.
    Reporting group description
    		 -

    Reporting group title
    Additional injection of 0.5% levobupivacaine via a trocar
    Reporting group description
    		 -

    Reporting group title
    Additional intraperitoneal atomization of levobupivacaine.
    Reporting group description
    		 -

    Serious adverse events
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Infiltration of portal sites with 0,5% levobupivacaine. Additional injection of 0.5% levobupivacaine via a trocar Additional intraperitoneal atomization of levobupivacaine.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were recorded for the participating patients.

    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.
    Due to a surgeons decision to stop performing laparascopic gynecological surgery in daycare, we were left without study patients. There were no results, since no analysis was performed due to limited data.
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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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