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    Clinical Trial Results:
    Epidural ropivacaine as part of a multimodal postoperative pain treatment following thoracolumbar spinal fusion surgery.

    Summary
    EudraCT number
    		 2014-004713-91
    Trial protocol
    		 BE  
    Global end of trial date
    06 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2025
    First version publication date
    03 May 2025
    Other versions
    Summary report(s)
    		 Article_Tose

    Trial information

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    Trial identification
    Sponsor protocol code
    ROPISPINE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussel
    Sponsor organisation address
    Laarbeeklaan, Brussel, Belgium,
    Public contact
    Study Coordinator, UZ Brussel, virgini.vanbuggenhout@uzbrussel.be
    Scientific contact
    Study Coordinator, UZ Brussel, virgini.vanbuggenhout@uzbrussel.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
    23 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study is to determine if infusion with ropivacaine at a rate of 7 mL/h is an effective additional treatment for postoperative pain after thoracolumbar spinal fusion surgery.
    Protection of trial subjects
    Patient safety was assessed during study condut. Diring srgery patient was followed by PI, anesthesiologist and surgery team. Afterwards they were followed up by medical staff. At the pacu they had to give pain scores every 10 minutes, in that pain and AE's could be assessed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2014
    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: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who were scheduled for thoracic or lumbar posterior interbody fusion surgery between december 2014 and December 2015 were included.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 33
    Number of subjects completed
    		 30

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 not the right premedication was given: 2
    Reason: Number of subjects
    		 problem during surgery, no epidural possible: 1
    Period 1
    Period 1 title
    study conduct (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    Only PI is not blinded and prepares the medication to be given to the patient, everybody else in the theatre room is blinded. Block randomization was used. All patients scheduled for surgery on a certain day were randomized to the same group.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Saline
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    continuous infusion of 0.9% saline

    Arm title
    		 treatment group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ropivacaine
    Investigational medicinal product code
    ropivacaine
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    continuous infusion of 0.2% ropivacaine during surgery

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Only the PI was not blinded in this study. Everybody else was blinded (patient, anesthesiologist, surgeon,...)
    Number of subjects in period 1 [2]
    		placebo group treatment group
    Started
    14
    16
    Completed
    14
    16
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 17 patients were included in the placebo group at first, however not the right premedication was given before surgery and for one patient placement of an epidural wasn't possible. Those 3 were excluded from the study. No data was used from them.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    placebo group
    Reporting group description
    		 -

    Reporting group title
    treatment group
    Reporting group description
    		 -

    Reporting group values
    		 placebo group treatment group Total
    Number of subjects
    		 14 16 30
    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)
    		 62 ( 16 ) 55 ( 18 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 8 15
        Male
    		 7 8 15
    ASA class
    Units: Subjects
        ASA 1
    		 3 4 7
        ASA 2
    		 9 10 19
        ASA 3
    		 2 2 4
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 70 ( 12.7 ) 79.8 ( 18.6 ) -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 165.9 ( 7.7 ) 171.7 ( 11.7 ) -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 26.5 ( 3.7 ) 24.9 ( 10.2 ) -
    preoperative VAS
    Units: pain score
        arithmetic mean (standard deviation)
    		 3 ( 3.1 ) 3.4 ( 2.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    placebo group
    Reporting group description
    		 -

    Reporting group title
    treatment group
    Reporting group description
    		 -

    Primary: VAS Score

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    End point title
    		 VAS Score
    End point description
    End point type
    Primary
    End point timeframe
    VAS Score were taken at arrival at PACU and then every 10 minutes while still on PACU. VAS score was also measured on day of surgery (day 0), day 1 and day 2.
    End point values
    		 placebo group treatment group
    Number of subjects analysed
    14
    16
    Units: pain score
    arithmetic mean (standard deviation)
        First PACU
    7.2 ( 3.7 )
    4.5 ( 3.9 )
        mean PACU
    5.7 ( 0.9 )
    3.6 ( 3 )
        Day 0
    5 ( 2.9 )
    3.5 ( 1.5 )
        Day 1
    2.8 ( 1.5 )
    2 ( 0.7 )
        Day 2
    2.1 ( 0.8 )
    1.7 ( 1.2 )
    Statistical analysis title
    		 VAS Score
    Statistical analysis description
    We aimed to detect a 40% reduction in VAS score in the treatment group as compared with the control group. We set type I error α = 0.05 (two-sided) and type II error b = 0.2. For statistical analysis SPSS Statistics® version 23 was used. The normality of the distribution was assessed using Kolmogorov-Smirnov test. The student T-test was used for analysing the differences between the two groups.
    Comparison groups
    placebo group v treatment group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Supplemental opioid consumption

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    End point title
    		 Supplemental opioid consumption
    End point description
    End point type
    Primary
    End point timeframe
    supplemental opioid consumption was captured in the OR (mg sufentanyl) at the PACU (mg piritramide) and on day 0, day 1 and day 2 (mg oxycodone).
    End point values
    		 placebo group treatment group
    Number of subjects analysed
    14
    16
    Units: milligram(s)
    arithmetic mean (standard deviation)
        OR
    41.4 ( 14.2 )
    55.5 ( 23.5 )
        PACU
    14.8 ( 10.9 )
    9 ( 7.5 )
        Day 0
    10.5 ( 11.4 )
    6.9 ( 7.3 )
        Day 1
    11.4 ( 10.5 )
    6.8 ( 7.9 )
        Day 2
    11.8 ( 15.9 )
    6 ( 7.5 )
    Statistical analysis title
    		 opioid consumption
    Statistical analysis description
    Assuming a standard deviation of 2, a minimum of 16 patients per group would be required. We set type I error α = 0.05 (two-sided) and type II error b = 0.2. For statistical analysis SPSS Statistics® version 23 was used. The normality of the distribution was assessed using the Kolmogorov-Smirnov test. The student T-test was used for analysing the differences between the two groups.
    Comparison groups
    treatment group v placebo group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Secondary: day of mobilization

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    End point title
    		 day of mobilization
    End point description
    End point type
    Secondary
    End point timeframe
    day of mobilization is the day patients started walking again after surgery.
    End point values
    		 placebo group treatment group
    Number of subjects analysed
    14
    16
    Units: days
    arithmetic mean (standard deviation)
        Mobilization
    1.5 ( 1 )
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Hospitalization

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    End point title
    		 Hospitalization
    End point description
    End point type
    Secondary
    End point timeframe
    length of stay of hospitalization
    End point values
    		 placebo group treatment group
    Number of subjects analysed
    14
    16
    Units: days
    arithmetic mean (standard deviation)
        hospitalization
    9.6 ( 5.6 )
    6.7 ( 3.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were captured as from time of signing the ICF till end of the hospitalization.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    placebo group
    Reporting group description
    		 -

    Reporting group title
    treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 placebo group treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (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: 5%
    Non-serious adverse events
    		 placebo group treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 14 (35.71%)
    6 / 16 (37.50%)
    Nervous system disorders
    Paresthesia
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    abdominal discomfort
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    Constipation
         subjects affected / exposed
    4 / 14 (28.57%)
    4 / 16 (25.00%)
         occurrences all number
    4
    4
    Respiratory, thoracic and mediastinal disorders
    respiratory depression
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (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 reported
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