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    Clinical Trial Results:
    Will intrathecal analgesia contribute to a faster recovery compared with epidural analgesia after open surgery for gynecological cancer. An open controlled randomized study.

    Summary
    EudraCT number
    		 2013-001873-25
    Trial protocol
    		 SE  
    Global end of trial date
    17 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2024
    First version publication date
    27 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    vers20130714
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02026687
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Östergötland
    Sponsor organisation address
    University Hospital, Linköping, Sweden, 581 83
    Public contact
    Lena Nilsson, Region Östergötland, +46 0101031838, lena.nilsson@regionostergotland.se
    Scientific contact
    Lena Nilsson, Region Östergötland, +46 0101031838, lena.nilsson@regionostergotland.se
    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
    17 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - to decide if one in a fast track program by the use of intrathecal analgesia and standardized criteria for discharge will have a faster physical recovery, so a larger proportion of patients can be discharged on the third day after surgery, than if epidural analgesia has been used per- and postoperatively. - to decide if the use of perioperative intrathecal analgesia contributes to a faster recovery of health related quality of health, less postoperative symptom and influence on vital signs compared with postoperative epidural analgesia
    Protection of trial subjects
    According to ethical committées approval and Sedish Regulations. Authorised monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    60
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From March 2014 to January 2016, all women who were admitted to the Department of Obstetrics and Gynaecology, University Hospital, Linköping, Sweden due to a proven or assumed gynaeco- logical abdominal malignancy were eligible for the study.

    Pre-assignment
    Screening details
    		 • Women 18 – 70 years. • Gynecological cancer (suspected or verified) planned for explorative laparatomy through a middle-line with a curative purpose. • WHO performance status < 2. • ASA 1-2. • Understand and can express themselves in Swedish. • After verbal and written information accept participation iand signed informed consent.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intra thecal morphine (ITM)
    Arm description
    		 intrathecal combination of a single-dose isobar bupivacaine 15mg, morphine 0.2mg and clonidine 75μg before surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Catapresan
    Investigational medicinal product code
    PR2
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradural use
    Dosage and administration details
    clonidine 75μg injected intrathecally in a combination of a single-dose isobar bupivacaine 15mg and morphine 0.2mg through a spinal needle

    Investigational medicinal product name
    Marcain spinal 5 mg/ml
    Investigational medicinal product code
    PR6
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    an intrathecal combination of a single-dose isobar bupivacaine 15mg, morphine 0.2mg and clonidine 75μg, through a spinal needle

    Investigational medicinal product name
    Morfin Special 0,4 mg/ml
    Investigational medicinal product code
    PR7
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratracheal use
    Dosage and administration details
    An intrathecal combination of a single-dose isobar bupivacaine 15mg, morphine 0.2mg and clonidine 75μg, through a spinal needle

    Arm title
    		 Epidural analgesia (EDA)
    Arm description
    		 The EDA group had the standard EDA regime used in the hospital. The EDA was performed by a low thoracic puncture. The epidural infusion was started after induction of the general anaesthesia but before surgery by a bolus dose of fentanyl 50–100 μg and a bolus from a mixture of bupivacaine 2.4 mg/mL, adrenalin 2.4 μg/mL and fentanyl 1.8 μg/mL. The same mixture was used as a continuous infusion, typically 4–8mL/hour, throughout surgery.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carbocain adrenalin 20mg/ml + 5 mikrogram/ml
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Epidural use
    Dosage and administration details
    Used as a continuous infusion, typically 4–8mL/hour, throughout surgery.

    Investigational medicinal product name
    Fentanyl B Braun 50 mikrogram/ml
    Investigational medicinal product code
    PR3
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Epidural use
    Dosage and administration details
    The epidural infusion was started after induction of the general anaesthesia but before surgery by a bolus dose of fentanyl 50–100 μg

    Number of subjects in period 1
    		Intra thecal morphine (ITM) Epidural analgesia (EDA)
    Started
    40
    40
    Completed
    40
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intra thecal morphine (ITM)
    Reporting group description
    		 intrathecal combination of a single-dose isobar bupivacaine 15mg, morphine 0.2mg and clonidine 75μg before surgery

    Reporting group title
    Epidural analgesia (EDA)
    Reporting group description
    		 The EDA group had the standard EDA regime used in the hospital. The EDA was performed by a low thoracic puncture. The epidural infusion was started after induction of the general anaesthesia but before surgery by a bolus dose of fentanyl 50–100 μg and a bolus from a mixture of bupivacaine 2.4 mg/mL, adrenalin 2.4 μg/mL and fentanyl 1.8 μg/mL. The same mixture was used as a continuous infusion, typically 4–8mL/hour, throughout surgery.

    Reporting group values
    		 Intra thecal morphine (ITM) Epidural analgesia (EDA) Total
    Number of subjects
    		 40 40 80
    Age categorical
    Age
    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)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        less than 50 years
    		 6 7 13
        50-60 years
    		 20 16 36
        over 60 years
    		 14 17 31
    Gender categorical
    Units: Subjects
        Female
    		 40 40 80
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Intra thecal morphine (ITM)
    Reporting group description
    		 intrathecal combination of a single-dose isobar bupivacaine 15mg, morphine 0.2mg and clonidine 75μg before surgery

    Reporting group title
    Epidural analgesia (EDA)
    Reporting group description
    		 The EDA group had the standard EDA regime used in the hospital. The EDA was performed by a low thoracic puncture. The epidural infusion was started after induction of the general anaesthesia but before surgery by a bolus dose of fentanyl 50–100 μg and a bolus from a mixture of bupivacaine 2.4 mg/mL, adrenalin 2.4 μg/mL and fentanyl 1.8 μg/mL. The same mixture was used as a continuous infusion, typically 4–8mL/hour, throughout surgery.

    Primary: Hospital stay

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    End point title
    		 Hospital stay
    End point description
    Lenght of hospital stay
    End point type
    Primary
    End point timeframe
    Days
    End point values
    		 Intra thecal morphine (ITM) Epidural analgesia (EDA)
    Number of subjects analysed
    40
    40
    Units: Days
        median (inter-quartile range (Q1-Q3))
    3.3 (3.1 to 4.8)
    4.3 (3.4 to 5.4)
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Intra thecal morphine (ITM) v Epidural analgesia (EDA)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Quality of life

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    End point title
    		 Quality of life
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (preoperatively) and 42 days after surgery
    End point values
    		 Intra thecal morphine (ITM) Epidural analgesia (EDA)
    Number of subjects analysed
    38
    39
    Units: Arbitrary Units
        median (inter-quartile range (Q1-Q3))
    38 (35 to 42)
    39 (34 to 44)
    Statistical analysis title
    		 Mann_whitney U-test
    Comparison groups
    Intra thecal morphine (ITM) v Epidural analgesia (EDA)
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From day of surgery until 6 weeks postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CRF
    Dictionary version
    2013-12-23
    Reporting groups
    Reporting group title
    Intra thecal morphine (ITM)
    Reporting group description
    		 -

    Reporting group title
    Epidural analgesia (EDA)
    Reporting group description
    		 -

    Serious adverse events
    		 Intra thecal morphine (ITM) Epidural analgesia (EDA)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 40 (12.50%)
    4 / 40 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intra-abdominal infection
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 40 (7.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intra thecal morphine (ITM) Epidural analgesia (EDA)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 40 (7.50%)
    6 / 40 (15.00%)
    Infections and infestations
    superficial wound infection
         subjects affected / exposed
    3 / 40 (7.50%)
    6 / 40 (15.00%)
         occurrences all number
    3
    6

    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/30837253
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