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    Clinical Trial Results:
    Comparison of continuous Lumbar Epidural (LEP) and Transversus Abdominis Plane (TAP) Blockade in the management of postoperative pain post abdominal surgery.

    Summary
    EudraCT number
    		 2006-004317-18
    Trial protocol
    		 IE  
    Global end of trial date
    28 May 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2022
    First version publication date
    22 Oct 2022
    Other versions
    Summary report(s)
    		 Prostate
    Morphine consumption
    Pain scores up to 24hr
    Pain scores 24hr to 72hr.
    Intraoperative hemodynamics
    Postoperative hemodynamics
    Sensory block level

    Trial information

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    Trial identification
    Sponsor protocol code
    TAP4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept Anaesthesia, UCHG
    Sponsor organisation address
    Newcastle Rd, Galway, Ireland,
    Public contact
    Dr Olivia Finnerty, Dept Anaesthesia, University College Hospital Galway, +353 91544074, olivia.finnerty@hse.ie
    Scientific contact
    Dr Olivia Finnerty, Dept Anaesthesia, University College Hospital Galway, +353 91544074, olivia.finnerty@gmail.com
    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
    30 Apr 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2010
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    In this study, we aim to compare the analgesic efficacy of TAP block to epidural blockade in the first 72 postoperative hours by monitoring pain score, in patients undergoing retropubic prostatectomy, in a randomized controlled single blind clinical trial.
    Protection of trial subjects
    Each patient was reminded that they were free to discontinue participation in the trial at any time. The option of further analgesia was available to all patients at all times.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2008
    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
    Ireland: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    57
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Each patient was invited to enroll in the study when they were booked for open retropubic prostate surgery.

    Pre-assignment
    Screening details
    		 ASA I-III men, between 18 and 80 years, presenting for elective retropubic prostatectomy, via an infra-umbilical incision in a prospective randomized, single blinded, controlled, clinical trial. Exclusion criteria included relevant drug allergy, a contraindication to neuraxial analgesia, renal dysfunction or sepsis.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Epidural
    Arm description
    		 This group had epidural analgesia
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Levobupivacaine
    Investigational medicinal product code
    PL00037/0300
    Other name
    CHirocaine
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Levobupivacaine 0.25% was given into the epidural space and a continuous infusion started for 24hrs.

    Arm title
    		 TAP block
    Arm description
    		 This group received a TAP block intraoperatively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Levobupivacaine
    Investigational medicinal product code
    PL00037/0300
    Other name
    CHirocaine
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Not mentioned
    Dosage and administration details
    0.25% Levobupivacaine was used to perform the TAP block. Each patient received 30ml each side, i.e. 60ml in total.

    Number of subjects in period 1
    		Epidural TAP block
    Started
    41
    31
    Completed
    29
    31
    Not completed
    12
    0
         Protocol deviation
    12
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epidural
    Reporting group description
    		 This group had epidural analgesia

    Reporting group title
    TAP block
    Reporting group description
    		 This group received a TAP block intraoperatively.

    Reporting group values
    		 Epidural TAP block Total
    Number of subjects
    		 41 31 72
    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)
    		 34 26 60
        From 65-84 years
    		 7 5 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.7 ( 7.9 ) 59.3 ( 7.2 ) -
    Gender categorical
    Units: Subjects
        Male
    		 41 31 72

    End points

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    End points reporting groups
    Reporting group title
    Epidural
    Reporting group description
    		 This group had epidural analgesia

    Reporting group title
    TAP block
    Reporting group description
    		 This group received a TAP block intraoperatively.

    Primary: End point

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    End point title
    		 End point
    End point description
    End point type
    Primary
    End point timeframe
    The primary outcome measure in this study was pain severity at rest and on movement over the first 24 postoperative hours.
    End point values
    		 Epidural TAP block
    Number of subjects analysed
    29
    31
    Units: 0 to 10
        arithmetic mean (standard deviation)
    0.97 ( 0.64 )
    2.16 ( 1.01 )
    Attachments
    		 Untitled (Filename: Pain Scores at Rest and Movement.jpg)
    Untitled (Filename: Postoperative Morphine Consumption.jpg)
    Statistical analysis title
    		 Satistical analysis
    Statistical analysis description
    Statistical analyses were performed using a standard statistical program (Sigmastat 3.5, Systat Software, San Jose, CA, USA). Demographic data were analyzed using Student’s t or Fisher’s exact tests as appropriate. The data were tested for normality using the Kolmogorov-Smirnov normality test. Repeated measurements (e.g. pain scores, heart rate, blood pressure) were analyzed by repeated measures ANOVA where normally distributed, with paired comparisons performed using the t test.
    Comparison groups
    Epidural v TAP block
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.01 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - See figure 'Pain scores in the first 24hours' for interval p values.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored from the start of anaesthesia until after the last data collection time point at 72hours.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Adverse Events TAP group
    Reporting group description
    		 -

    Reporting group title
    Adverse events Epidural group
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse Events TAP group Adverse events Epidural group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Non ST elevated MI
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 29 (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
    Respiratory arrest
    Additional description: One patient developed respiratory arrest while on his PCA morphine. This lead to a NSTEMI and TIA. He was resusitated with naloxone and moved to the ICU. He made a fully recovery. He failed to disclose known coronary artery disease preoperatively
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Adverse Events TAP group Adverse events Epidural group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    Nervous system disorders
    Epidural puncture
    Additional description: One patient had a dural puncture during epidural insertion. The epidural was successfully re sited and used successfully. The patient did not develop a headache.
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    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? Yes
    Date
    Interruption
    Restart date
    06 Jul 2009
    The study was paused for 3 months due to serious illness and death of one of the core investigators
    28 Sep 2009
    01 Mar 2010
    One of the core investigators was travelling to New Zealand and travel home was delayed by three weeks due the eruption of the Icelandic Volcano that caused airline traffic chaos.
    12 Apr 2010

    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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