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    Clinical Trial Results:
    Laparoscopically inserted transversus abdominis plane block versus local wound anesthesia in laparoscopic peritoneal endometriosis surgery: a prospective randomized controlled double-blinded LTAP-trial

    Summary
    EudraCT number
    		 2020-004353-80
    Trial protocol
    		 FI  
    Global end of trial date
    20 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2025
    First version publication date
    20 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    179/2020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04735770
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oulu university hospital
    Sponsor organisation address
    Kajaanintie 50, Oulu, Finland, 90220
    Public contact
    Department of obstetrics and gynecology, Oulu University hospital, sari.koivurova@fimnet.fi
    Scientific contact
    Department of obstetrics an gynecology, Oulu University hospital, sari.koivurova@fimnet.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
    03 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to compare the effect and safety of LTAP (Chirocaine 2,5 mg/ml 40 ml) to local wound analgesia (Chirocaine 5mg/ml 10 ml) treating post-laparoscopic pain measured by postoperative opioid consumption.
    Protection of trial subjects
    The trial subjects were endometriosis patients who received surgical treatment for their disease. Their possible pain and distress were treated according to generally accepted postoperative treatment protocols such as pain or antiemetic medication and epidural analgesic if needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2020
    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: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was conducted in a single tertiary hospital starting May 2021 and finishing December 2023.

    Pre-assignment
    Screening details
    		 Eligible patients were 18-50 yrs of age, ASA 1-3, diagnosed or suspected with endometriosis with indication to surgery. Exclusion criteria: sleep apnea, ASA>3, contraindications to opioids or NSAIDs, continuous opioid intake preoperatively.

    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
    		 LTAP arm
    Arm description
    		 The group of patients who received LTAP-block.
    Arm type
    		 Experimental

    Investigational medicinal product name
    levobupivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    LTAP-arm: Levobupivacain 2,5 mg/ml in total 40 ml was administered via LTAP-route and 10 ml of saline was administered locally. Local wound analgesia arm: Levobupivacain 5mg/ml was administered locally and 40 ml saline via LTAP-route.

    Investigational medicinal product name
    levobupivacain
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    LTAP-arm: Levobupivacain 2,5 mg/ml in total 40 ml was administered via LTAP-route and 10 ml of saline was administered locally. Local wound analgesia arm: Levobupivacain 5mg/ml was administered locally and 40 ml saline via LTAP-route.

    Arm title
    		 Local wound analgesia arm
    Arm description
    		 The group of patients who received local wound analgesia.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    levobupivacain 5 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Local wound analgesia arm: Levobupivacain 5mg/ml was administered locally and 40 ml saline via LTAP-route.

    Number of subjects in period 1
    		LTAP arm Local wound analgesia arm
    Started
    23
    23
    Completed
    23
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LTAP arm
    Reporting group description
    		 The group of patients who received LTAP-block.

    Reporting group title
    Local wound analgesia arm
    Reporting group description
    		 The group of patients who received local wound analgesia.

    Reporting group values
    		 LTAP arm Local wound analgesia arm Total
    Number of subjects
    		 23 23 46
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.9 ( 8.24 ) 27.1 ( 6.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 23 46
        Male
    		 0 0 0
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.0 ( 5.49 ) 25.8 ( 6.21 ) -

    End points

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    End points reporting groups
    Reporting group title
    LTAP arm
    Reporting group description
    		 The group of patients who received LTAP-block.

    Reporting group title
    Local wound analgesia arm
    Reporting group description
    		 The group of patients who received local wound analgesia.

    Primary: Opioid consumption

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    End point title
    		 Opioid consumption
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative total opioid consumption from the recovery room until hospital discharge.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: mg
        arithmetic mean (standard deviation)
    31.8 ( 25.5 )
    27.5 ( 19.3 )
    Statistical analysis title
    		 Parametric test
    Comparison groups
    Local wound analgesia arm v LTAP arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Postoperative pain recovery room

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    End point title
    		 Postoperative pain recovery room
    End point description
    Pain NRS was measured on a scale 0-10.
    End point type
    Primary
    End point timeframe
    Postoperative pain measured at the recovery room.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: numbers
    6
    7
    Statistical analysis title
    		 Student's T-Test
    Comparison groups
    LTAP arm v Local wound analgesia arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: postoperative pain at 6 hours

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    End point title
    		 postoperative pain at 6 hours
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative pain a 6 hours on a scale of 0-10.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: numbers
    3
    3
    Statistical analysis title
    		 student's T-test
    Comparison groups
    LTAP arm v Local wound analgesia arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Postoperative pain at 12 hours

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    End point title
    		 Postoperative pain at 12 hours
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative pain at 12 hours on a scale of 0-10.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: numbers
    2
    3
    Statistical analysis title
    		 student's T-test
    Comparison groups
    LTAP arm v Local wound analgesia arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Postoperative pain at 24 hours

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    End point title
    		 Postoperative pain at 24 hours
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative pain at 24 hours on scale of 0-10.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: numbers
    4
    3
    Statistical analysis title
    		 student's t-test
    Comparison groups
    LTAP arm v Local wound analgesia arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Time to discharge

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    End point title
    		 Time to discharge
    End point description
    End point type
    Primary
    End point timeframe
    Time to discharge from the hospital.
    End point values
    		 LTAP arm Local wound analgesia arm
    Number of subjects analysed
    23
    23
    Units: hours
        arithmetic mean (standard deviation)
    24 ( 4 )
    28 ( 14 )
    Statistical analysis title
    		 Student's t-test
    Comparison groups
    LTAP arm v Local wound analgesia arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events due to intervention studied would have been assessed during surgery (at the time of intervention) or during hospitalization. Adverse event due to surgery were assessed within a month after surgery.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    LTAP-group
    Reporting group description
    		 23 subjects receiving LTAP block.

    Reporting group title
    Local wound analgesia group
    Reporting group description
    		 23 study subjects receiving local wound analgesia.

    Serious adverse events
    		 LTAP-group Local wound analgesia group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 23 (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: 2%
    Non-serious adverse events
    		 LTAP-group Local wound analgesia group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
    Infections and infestations
    postoperative infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0

    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.
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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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