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    Clinical Trial Results:
    Analgésie post-césarienne: intérêt de l'injection sous-aponévrotique d'anesthésique local par cathéter multiperforé, par rapport à la morphine intrathécale.

    Summary
    EudraCT number
    		 2012-000647-27
    Trial protocol
    		 BE  
    Global end of trial date
    12 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2021
    First version publication date
    30 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHU-930106
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02264821
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chu Brugmann
    Sponsor organisation address
    4 Place A. Van Gehuchten , Brussels, Belgium, 1020
    Public contact
    Philippe Van der Linden , CHU Brugmann, 32 024772330, Philippe.VANDERLINDEN@chu-brugmann.be
    Scientific contact
    Philippe Van der Linden , CHU Brugmann, 32 024772330, Philippe.VANDERLINDEN@chu-brugmann.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
    12 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of the duration of postoperative analgesia and side effects of two perioperative analgesia techniques: either the infusion of local anesthetic via a multiperforated catheter or the addition of intrathecal morphine compared to a placebo in elective cesarean sections under spinal anesthesia.
    Protection of trial subjects
    According to the standard of care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2012
    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: 182
    Worldwide total number of subjects
    182
    EEA total number of subjects
    182
    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)
    182
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 478 patients were assessed for eligibility. 192 patients were randomized. 182 patients were analyzed (due to pump technical problems (5), catheter misplacement (1), surgical reason to not insert catheter (2), midline incision (1), vaginal delivery (1)).

    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
    		 Investigator, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 Bupivacaine spine anesthesia 0.5 HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bupivacaine 0.5% 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Bupivacaine 0.5% 10mg, intrathecal use, solution for injection

    Investigational medicinal product name
    Sufentanyl 5µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Sufentanyl 5µg intrathecal injection

    Arm title
    		 Group rachi morphine
    Arm description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 mg of morphine (0.1 ml) and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine 0.5% 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Bupivacaine 0.5% 10mg, intrathecal use, solution for injection

    Investigational medicinal product name
    Sufentanil 5µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Sufentanil 5µg intrathecal injection

    Investigational medicinal product name
    Morphine 100µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Morphine 100µg, intrathecal injection

    Arm title
    		 Group catheter
    Arm description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infuser pump containing 300ml of ropivacaine 2mg / ml delivering 10ml / h for 30h
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine 0.5% 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Bupivacaine 0.5% 10mg, intrathecal use, solution for injection

    Investigational medicinal product name
    Sufentanyl 5µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Sufentanyl 5µg intrathecal injection

    Investigational medicinal product name
    Ropivacaine 0.2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ropivacaine 0.2% 10ml/h during 30h

    Number of subjects in period 1
    		Control group Group rachi morphine Group catheter
    Started
    58
    61
    63
    Completed
    58
    61
    63

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Bupivacaine spine anesthesia 0.5 HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h.

    Reporting group title
    Group rachi morphine
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 mg of morphine (0.1 ml) and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h

    Reporting group title
    Group catheter
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infuser pump containing 300ml of ropivacaine 2mg / ml delivering 10ml / h for 30h

    Reporting group values
    		 Control group Group rachi morphine Group catheter Total
    Number of subjects
    		 58 61 63 182
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 58 61 63 182
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 58 61 63 182
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Bupivacaine spine anesthesia 0.5 HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h.

    Reporting group title
    Group rachi morphine
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 mg of morphine (0.1 ml) and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h

    Reporting group title
    Group catheter
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infuser pump containing 300ml of ropivacaine 2mg / ml delivering 10ml / h for 30h

    Primary: Duration of effective analgesia

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    End point title
    		 Duration of effective analgesia
    End point description
    End point type
    Primary
    End point timeframe
    Duration of effective analgesia defined as the time between the completion of spinal analgesia and the first morphine request by the patient.
    End point values
    		 Control group Group rachi morphine Group catheter
    Number of subjects analysed
    58
    61
    63
    Units: minutes
    247
    380
    351
    Statistical analysis title
    		 Kruskal-wallis Rank test
    Comparison groups
    Control group v Group rachi morphine v Group catheter
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Morphine Consumption

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    End point title
    		 Morphine Consumption
    End point description
    End point type
    Secondary
    End point timeframe
    During the first 30h following spinal anesthesia
    End point values
    		 Control group Group rachi morphine Group catheter
    Number of subjects analysed
    58
    61
    63
    Units: mg
    21
    10
    8
    Statistical analysis title
    		 Kruskal-wallis
    Statistical analysis description
    Kruskal-wallis followed by Tuckey's multiple comparisons test
    Comparison groups
    Control group v Group rachi morphine v Group catheter
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire clinical trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clinical practice
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Bupivacaine spine anesthesia 0.5 HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h.

    Reporting group title
    Group rachi morphine
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 mg of morphine (0.1 ml) and placement of a multiperforated catheter with an elastomeric infusor pump containing 300 ml of placebo delivering 10ml / h for 30h

    Reporting group title
    Group catheter
    Reporting group description
    		 Bupivacaine spinal anesthesia 0.5% HB 10mg + Sufenta 5µg + 0.1 ml of placebo and placement of a multiperforated catheter with an elastomeric infuser pump containing 300ml of ropivacaine 2mg / ml delivering 10ml / h for 30h

    Serious adverse events
    		 Control group Group rachi morphine Group catheter
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control group Group rachi morphine Group catheter
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 58 (51.72%)
    35 / 61 (57.38%)
    31 / 63 (49.21%)
    Cardiac disorders
    Hypotension
         subjects affected / exposed
    30 / 58 (51.72%)
    23 / 61 (37.70%)
    22 / 63 (34.92%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 58 (15.52%)
    18 / 61 (29.51%)
    10 / 63 (15.87%)
         occurrences all number
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    21 / 58 (36.21%)
    35 / 61 (57.38%)
    31 / 63 (49.21%)
         occurrences all number
    1
    1
    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? 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/28368941
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