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    Clinical Trial Results:
    Optimal postoperative pain management by ultrasoundguided abdominal wall nerve blockade for laparoscopic surgery for acute appendicitis - a randomised controlled trial.

    Summary
    EudraCT number
    		 2013-001400-11
    Trial protocol
    		 DK  
    Global end of trial date
    14 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2021
    First version publication date
    20 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BBH-BDTAP-APP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01825863
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Anaesthesiology and Intensive Care
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Department of anesthesiology Z, Bispebjerg Hospital, 45 35 31 27 83, z-afd.bispebjerghospital@regionh.dk
    Scientific contact
    Department of anesthesiology Z, Bispebjerg Hospital, 45 35 31 27 83, z-afd.bispebjerghospital@regionh.dk
    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
    05 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore weather the use of the BD-TAP abdominal wall blockade for patients undergoing laparoscopic surgery due to acute appendicits can anesthetize the patients and therefore reduce the patient's postoperative pain and thus reduce their postoperative morphine consumption. The main objective is pain score in motion, from lying flat in bed to sitting up, assessed 0-12 hours postoperatively using the nummerical rating scale (NRS) 0-10.
    Protection of trial subjects
    All patients had their BD-TAP block administered while under general anaesthesia thus minimizing discomfort and pain. A PCA pump was fitted at the PACU to ensure sufficient postoperative pain management.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 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
    Denmark: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a single center study with all patients being recruited at Bispebjerg Hospital, Denmark. All patients admitted with acute appendicitis schduled for a laparoscopic appendectomy were screened.

    Pre-assignment
    Screening details
    		 84 patients were screened, 56 patients were included, 15 were excluded due to not meeting inclusion criteria , 7 declined to participate, 4 were not included due to logistical reasons , 2 had their surgery cancelled

    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, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 All patients in this arm received a bilateral dual TAP-blok with 60 mL 0.375% ropivacaine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    60 mL of 0.375% ropivacaine was administered as an ultrasound-guided nerve block

    Arm title
    		 Placebo
    Arm description
    		 All patients in this arm received a bilateral dual TAP block wit 60 mL isotonic saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natrium Chloride (isotonic)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Each participant received a BD-TAP block with 60 mL isotonic saline

    Number of subjects in period 1
    		Active Placebo
    Started
    28
    28
    Completed
    27
    25
    Not completed
    1
    3
         Cancelled surgery
    -
    1
         Equipment failure
    -
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 All patients in this arm received a bilateral dual TAP-blok with 60 mL 0.375% ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 All patients in this arm received a bilateral dual TAP block wit 60 mL isotonic saline

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 28 28 56
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.1 ± 14.3 29.1 ± 10.7 -
    Gender categorical
    Units: Subjects
        Female
    		 13 16 29
        Male
    		 15 12 27
    American Society of Anaesthesiology - group
    Units: Subjects
        One
    		 23 21 44
        Two
    		 5 6 11
        Three
    		 0 1 1
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 77.5 ± 14.8 73.1 ± 13.8 -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 All patients in this arm received a bilateral dual TAP-blok with 60 mL 0.375% ropivacaine

    Reporting group title
    Placebo
    Reporting group description
    		 All patients in this arm received a bilateral dual TAP block wit 60 mL isotonic saline

    Primary: Pain at mobilisation 0-12 hours

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    End point title
    		 Pain at mobilisation 0-12 hours
    End point description
    End point type
    Primary
    End point timeframe
    0-12 hours after surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Area under the curve
        median (inter-quartile range (Q1-Q3))
    34 (19 to 46)
    50 (30 to 59)
    Statistical analysis title
    		 Mann-Whitney test
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Pain 0-12 hours (at rest)

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    End point title
    		 Pain 0-12 hours (at rest)
    End point description
    End point type
    Secondary
    End point timeframe
    0-12 hours post surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Nummerical rating scale
        median (inter-quartile range (Q1-Q3))
    25 (10 to 33)
    31 (24 to 43)
    No statistical analyses for this end point

    Secondary: Morphine consumption

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    End point title
    		 Morphine consumption
    End point description
    End point type
    Secondary
    End point timeframe
    Total opioid consumption 0-12 hours post surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Miligrams
        median (inter-quartile range (Q1-Q3))
    10 (0 to 18)
    20 (5 to 30)
    No statistical analyses for this end point

    Secondary: Nausea

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    End point title
    		 Nausea
    End point description
    End point type
    Secondary
    End point timeframe
    Any patients with nausea 0-12 hours post surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Subjects
    15
    14
    No statistical analyses for this end point

    Secondary: Postoperative antiemetics

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    End point title
    		 Postoperative antiemetics
    End point description
    End point type
    Secondary
    End point timeframe
    Number of patients needing antiemetics 0-12 hours post surgery
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: subjects
    10
    11
    No statistical analyses for this end point

    Secondary: Time at the PACU unit

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    End point title
    		 Time at the PACU unit
    End point description
    End point type
    Secondary
    End point timeframe
    Number of minutes spend at the Post Anaesthesia Care Unit
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Minutes
        median (inter-quartile range (Q1-Q3))
    85 (63 to 100)
    80 (70 to 115)
    No statistical analyses for this end point

    Secondary: Time to mobilisation

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    End point title
    		 Time to mobilisation
    End point description
    End point type
    Secondary
    End point timeframe
    Time to mobilisation post surgery (hours)
    End point values
    		 Active Placebo
    Number of subjects analysed
    27
    25
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    5.5 (3.1 to 8.3)
    6.7 (4.5 to 12.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The inclusion period was less than a year and so the annual adverse event report was submitted with the end of trial registration
    Adverse event reporting additional description
    3 patients were readmitted during the first 30 days post surgery. Non of these adverse events were believed to be associated with the trial mediciation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Active/ropivacaine
    Reporting group description
    		 One patient was readmitted with flu-like symptoms believed not to be associated with the treatment

    Reporting group title
    Placebo/isotonic saline
    Reporting group description
    		 One patient was readmitted with abdominal pain and one with and incisional abscess. Both incidents believed not to be associated with the trial medication

    Serious adverse events
    		 Active/ropivacaine Placebo/isotonic saline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (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
    		 Active/ropivacaine Placebo/isotonic saline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    Surgical and medical procedures
    Complications after appendectomy
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 2 (100.00%)
         occurrences all number
    1
    2

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26464041
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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
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