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    Clinical Trial Results:
    Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial

    Summary
    EudraCT number
    		 2020-001054-22
    Trial protocol
    		 DK  
    Global end of trial date
    09 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OPMICS-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04311099
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital - North Zealand
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark, 3400
    Public contact
    Sponsor, Claus Anders Bertelsen, +45 51 90 63 03, cabertelsen@gmail.com
    Scientific contact
    Sponsor, Claus Anders Bertelsen, +45 51 90 63 03, cabertelsen@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
    09 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to identify the “most simple non-inferior of three different methods”, placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound-guided transverse abdominal plane block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and LOS will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.
    Protection of trial subjects
    The trial was a pain management study, and all patients received treatment for pain in accordance with hospital guidelines, following generic pain management principles.
    Background therapy
    		 All patients received a bolus injection of Ropivacaine 2 mg/ml 20 ml around the extraction incision in the abdominal wall. Pain management was conducted in accordance with hospital guidelines and the WHO analgesic ladder.
    Evidence for comparator
    		 The trial included two interventions: the laparoscopic-assisted transversus abdominis plane block and the ultrasound-guided transversus abdominis plane block. The ultrasound-guided technique is the more common approach, whereas the laparoscopic-assisted technique is easier and more efficient. We concluded from the literature review that there was insufficient evidence regarding the effects of the transversus abdominis plane block; therefore, we chose to include a placebo group as a comparator. The trial was conducted step-wise. First, determining the superiority of the transversus abdominis plane block to placebo and then determining the non-inferiority of the laparoscopic-assisted technique to the ultrasound-guided technique.
    Actual start date of recruitment
    18 Jan 2021
    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: 360
    Worldwide total number of subjects
    360
    EEA total number of subjects
    360
    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
    240
    85 years and over
    17

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was undertaken in five Danish colorectal centres, with the first patient enrolment on January 18, 2021. Enrolment was undertaken in the outpatient clinic by a colorectal surgeon familiar with the trial protocol. Oral and written informed consent were obtained from 360 patients, with the final inclusion date being February 9, 2024.

    Pre-assignment
    Screening details
    		 668 patients fulfilled the inclusion criteria and were screened for inclusion. 184 did not meet the exclusion criteria, and 124 declined to participate. Primary reasons for exclusion were a history of open abdominal surgery, concomitant pain condition, language or psychiatric barrier.

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    All medications were packaged similarly, and both consistency and colour were similar and indistinguishable by clinicians and patients alike. Data were not unblinded until the analysis for the primary outcome had been conducted.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active laparoscopic block
    Arm description
    		 Received an active laparoscopic-assisted TAP block and a placebo ultrasound-guided TAP block.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacain ”Fresenius Kabi” 2 mg/ml
    Investigational medicinal product code
    45007
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60ml of Ropivacaine 2mg/ml administered as a peripheral nerve block and local infiltration analgesia.

    Arm title
    		 Active ultrasound-guided TAP block
    Arm description
    		 Received an active ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropivacain ”Fresenius Kabi” 2 mg/ml
    Investigational medicinal product code
    45007
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60ml of Ropivacaine 2mg/ml administered as a peripheral nerve block and local infiltration analgesia.

    Arm title
    		 Placebo
    Arm description
    		 Received a placebo ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natriumklorid "Fresenius Kabi" 9 mg/ml
    Investigational medicinal product code
    17927
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    80 ml of sodium chloride 9 mg/ml administered as TAP blocks.

    Number of subjects in period 1
    		Active laparoscopic block Active ultrasound-guided TAP block Placebo
    Started
    135
    135
    90
    Completed
    127
    127
    86
    Not completed
    8
    8
    4
         Protocol deviation
    8
    8
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active laparoscopic block
    Reporting group description
    		 Received an active laparoscopic-assisted TAP block and a placebo ultrasound-guided TAP block.

    Reporting group title
    Active ultrasound-guided TAP block
    Reporting group description
    		 Received an active ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.

    Reporting group title
    Placebo
    Reporting group description
    		 Received a placebo ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.

    Reporting group values
    		 Active laparoscopic block Active ultrasound-guided TAP block Placebo Total
    Number of subjects
    		 135 135 90 360
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 73.8 (63.7 to 78.5) 72.7 (64.5 to 77.9) 70.5 (61.7 to 77.9) -
    Gender categorical
    Units: Subjects
        Female
    		 50 66 49 165
        Male
    		 85 69 41 195

    End points

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    End points reporting groups
    Reporting group title
    Active laparoscopic block
    Reporting group description
    		 Received an active laparoscopic-assisted TAP block and a placebo ultrasound-guided TAP block.

    Reporting group title
    Active ultrasound-guided TAP block
    Reporting group description
    		 Received an active ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.

    Reporting group title
    Placebo
    Reporting group description
    		 Received a placebo ultrasound-guided TAP block and a placebo laparoscopic-assisted TAP block.

    Primary: 24 hour postoperative morphine equivalent consumption (intravenous in milligrams)

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    End point title
    		 24 hour postoperative morphine equivalent consumption (intravenous in milligrams)
    End point description
    End point type
    Primary
    End point timeframe
    24 hour postoperative consumption
    End point values
    		 Active laparoscopic block Active ultrasound-guided TAP block Placebo
    Number of subjects analysed
    127
    127
    86
    Units: milligram(s)/24 hours
        median (inter-quartile range (Q1-Q3))
    15.8 (8.3 to 25.2)
    19.2 (6.8 to 33.8)
    22.0 (13.3 to 33.3)
    Statistical analysis title
    		 Absolute difference L-TAP vs placebo
    Comparison groups
    Active laparoscopic block v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 -0.5
    Statistical analysis title
    		 Absolute difference US-TAP vs placebo
    Comparison groups
    Placebo v Active ultrasound-guided TAP block
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.55
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 4
    Statistical analysis title
    		 Absolute difference US-TAP vs L-TAP
    Comparison groups
    Active ultrasound-guided TAP block v Active laparoscopic block
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.5
    Confidence interval
         level
    		 98.75%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 -1.1

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    18. January 2021 to 9. March 2024.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD-10
    Dictionary version
    2019
    Reporting groups
    Reporting group title
    Medical and surgical complications to surgery
    Reporting group description
    		 Serious adverse events were registered as this trial was not examining new medications or procedures. No adverse events occurred due to the intervention or intervention medication. All adverse events were due to the surgical procedures for which the participants were admitted.

    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: Only serious adverse events were registered for this trial, as described in the trial protocol and approved by the Regional Committee on Health Research Ethics of the Capital Region of Denmark and the Danish Health and Medicines Authority.
    Serious adverse events
    		 Medical and surgical complications to surgery
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 360 (7.22%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Surgical and medical procedures
    Postoperative ileus
         subjects affected / exposed
    6 / 360 (1.67%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    5 / 360 (1.39%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    3 / 360 (0.83%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    4 / 360 (1.11%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound complication
    Additional description: Intraabdominal bleeding af a complication to surgery.
         subjects affected / exposed
    4 / 360 (1.11%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    4 / 360 (1.11%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Medical and surgical complications to surgery
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 360 (0.00%)

    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/34851250
    http://www.ncbi.nlm.nih.gov/pubmed/39542642
    http://www.ncbi.nlm.nih.gov/pubmed/40343534
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