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    Clinical Trial Results:
    A comparison of analgesic and respiratory effects from tapentadol versus oxycodone after laparoscopic hysterectomy.

    Summary
    EudraCT number
    		 2017-001285-23
    Trial protocol
    		 NO  
    Global end of trial date
    28 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2021
    First version publication date
    16 Oct 2021
    Other versions
    Summary report(s)
    		 Tapentadol versus oxycodone analgesia and side effects. Comelon. EJA 2021

    Trial information

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    Trial identification
    Sponsor protocol code
    170317-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03314792
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oslo University Hospital
    Sponsor organisation address
    Kirkeveien 166, Oslo, Norway, 0424
    Public contact
    Dept. of Anesthesiology, Ullevaal, Oslo University Hospital, 0047 2219690, marlin.comelon@ous-hf.no
    Scientific contact
    Dept. of Anesthesiology, Ullevaal, Oslo University Hospital, 0047 2219690, marlin.comelon@ous-hf.no
    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
    01 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary goal of our study is to examine the analgesic effects in patients receiving either tapentadol or oxycodone during the first postoperative day after hysterectomy.
    Protection of trial subjects
    All patients recived standard peri- and postoperative pain treatment according to hospital protocol in addition to the study medicine they were allocated to. All patients also recived information and thorough follow-up on what to expect and how to handle postoperative pain.
    Background therapy
    		 Perioperatively: paracetamol iv, etoricoxib (NSAID) po, dexamethasone iv, bupivacaine infiltration. Postoperativt pro re nata Fentanyl iv.
    Evidence for comparator
    		 Tapentadol is a new mixed ligand opioid which acts as a µ-opioid receptor (MOR) agonist and also inhibits noradrenaline reuptake in the central nervous system. This dual mechanism of action is believed to result in synergistic analgesic effects. Since opioid side effects are strongly related to MOR stimulation, tapentadol is expected to have less side effects than the pure opioid agonists. Tapentadol has been shown effective for acute and chronic nociceptive, neuropathic or cancer related pain, but there is lack of broad-based evidence for tapentadol in the postsurgical setting. To our knowledge, the published studies on analgesic effects from tapentadol are mainly industry funded studies on orthopaedic and dental patients, and few are related to procedures with major components of visceral pain, such as laparoscopy. A review of tapentadol studies in the postoperative setting indicated less nausea, vomiting, constipation and pruritus compared with oxycodone, but no difference in somnolence, headache or dizziness. Studies on respiratory depression from tapentadol in any setting are sparse. Oxycodone is a well-known opioid for postoperative pain treatment in all surgical settings. It is known to have several side effects such as nausea, vomiting, sedation, constipation and respiratory sedation.
    Actual start date of recruitment
    01 Dec 2017
    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
    Norway: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    86
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women assigned for elective hysterectomy for benigne reasons at Oslo University Hospital, Norway between December 2017 and February 2019.

    Pre-assignment
    Screening details
    		 Patients w/weight <55 kg, >85 kg or BMI >31 were excluded. Exclusion criteria: chronic pain syndromes, severe heart, lung, liver or kidney failure, severe psychiatric disorders, malignancy previous five yr, chronic medication opioids, steroids, benzodiazepines, gabapentanoids, tramadol, clonidine or serotonin-noradrenaline or allergies to study med

    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, Assessor
    Blinding implementation details
    Study medication was distributed in opaque, identical looking dosing boxes prepacked by a physician not participating in the treatment or evaluation of the patients. A dummy dosing box was demonstrated to the patients at the time of inclusion in order to prepare them for self-administration of rescue medicine. The researchers involved in inclusion, treatment and evaluation of the patients were blinded to which study medication the patients received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tapentadol (group T)
    Arm description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol
    Investigational medicinal product code
    Other name
    Palexia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received extended release (ER) tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. Immediate release (IR) tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Arm title
    		 Oxycodone (group O)
    Arm description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxycodone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Number of subjects in period 1
    		Tapentadol (group T) Oxycodone (group O)
    Started
    43
    43
    Completed
    37
    36
    Not completed
    6
    7
         Received analgesics outside protocol
    -
    3
         Change of surgical procedure
    1
    -
         Received epidural
    2
    1
         Change of anesthesia procedure
    1
    -
         Did not receive allocated intervention
    1
    -
         Received opioids outside protocol
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tapentadol (group T)
    Reporting group description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Reporting group title
    Oxycodone (group O)
    Reporting group description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Reporting group values
    		 Tapentadol (group T) Oxycodone (group O) Total
    Number of subjects
    		 43 43 86
    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
    18-64 years
    Units: years
        arithmetic mean (standard deviation)
    		 43.1 ± 5.9 44.6 ± 7.4 -
    Gender categorical
    Units: Subjects
        Female
    		 43 43 86
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Tapentadol (group T)
    Reporting group description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Reporting group title
    Oxycodone (group O)
    Reporting group description
    		 According to a computer-generated code, using block randomisation by blocks of ten, patients were allocated to receive either tapentadol (group T) or oxycodone (group O) during the study period. Group T received ER tapentadol 50 mg p.o. and group O received ER oxycodone 10 mg p.o. as part of premedication. After 12 h all patients received an additional dose of ER study medication. IR tapentadol 50 mg or oxycodone 10 mg were available as rescue medication.

    Primary: Pain at rest 1 h postoperatively

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    End point title
    		 Pain at rest 1 h postoperatively
    End point description
    The primary outcome, pain at rest 1 h postoperatively, was evaluated with the NRS
    End point type
    Primary
    End point timeframe
    The primary outcome, pain at rest 1 h postoperatively, was evaluated with the NRS
    End point values
    		 Tapentadol (group T) Oxycodone (group O)
    Number of subjects analysed
    37
    36
    Units: pain score
        arithmetic mean (confidence interval 95%)
    4.4 (3.8 to 5.0)
    4.6 (3.8 to 5.3)
    Statistical analysis title
    		 T- test on pain at rest 1 h postoperatively
    Comparison groups
    Tapentadol (group T) v Oxycodone (group O)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    0-72 h postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No relevant non serious adverse events were reported during the study

    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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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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