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    Clinical Trial Results:
    Intraoperative clonidine for postoperative pain management in patients undergoing surgical treatment for endometriosis: a prospective, double-blind, randomized controlled trial

    Summary
    EudraCT number
    		 2022-001810-21
    Trial protocol
    		 DK  
    Global end of trial date
    13 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Aug 2025
    First version publication date
    28 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2022-001810-21
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05560230
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital, Department of Anaesthesiology
    Sponsor organisation address
    Palle Juul Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Lone Nikolajsen, Aarhus University Hospital, Department of Anaesthesiology, +45 78464317, lone.nikolajsen@clin.au.dk
    Scientific contact
    Lone Nikolajsen, Aarhus University Hospital, Department of Anaesthesiology, +45 78464317, lone.nikolajsen@clin.au.dk
    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 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and Guidelines for Good Clinical Practice (GCP) and monitored by the GCP unit at Aarhus University Hospital, Aarhus, Denmark. The study protocol was approved by the Danish Protection Agency, Danish Research Ethics Committee, and the Danish Medicine Agency
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2022
    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
    Denmark: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled for endometriosis surgery will be approached. The anasthetists will go over study information. If patients give preliminary consent to participate, the project staff will contact them and provide them with information about the study. Patients will provide oral and written consent on the day of surgery.

    Pre-assignment
    Screening details
    		 The anasthetists will check in- and exclusion criteria during their visit to the clinic.

    Period 1
    Period 1 title
    Intervention (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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 The study drug was given as a single intravenous dose (clonidine 150 µg). 100 ml bag including isotonic saline and the study drug (clonidine 150 µg) will be infused over 5-10 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 microgram

    Arm title
    		 Control
    Arm description
    		 100 ml bag including isotonic saline and the study drug (isotonic saline) will be infused over 5-10 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details

    Number of subjects in period 1
    		Intervention Control
    Started
    57
    63
    Completed
    57
    63

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The study drug was given as a single intravenous dose (clonidine 150 µg). 100 ml bag including isotonic saline and the study drug (clonidine 150 µg) will be infused over 5-10 minutes.

    Reporting group title
    Control
    Reporting group description
    		 100 ml bag including isotonic saline and the study drug (isotonic saline) will be infused over 5-10 minutes.

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 57 63 120
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 57 63 120
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37 ( 7 ) 37 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 57 63 120

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The study drug was given as a single intravenous dose (clonidine 150 µg). 100 ml bag including isotonic saline and the study drug (clonidine 150 µg) will be infused over 5-10 minutes.

    Reporting group title
    Control
    Reporting group description
    		 100 ml bag including isotonic saline and the study drug (isotonic saline) will be infused over 5-10 minutes.

    Primary: Cumulative opioid consumption (IV morphine)

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    End point title
    		 Cumulative opioid consumption (IV morphine)
    End point description
    End point type
    Primary
    End point timeframe
    within the first three hours after arrival at the post-anesthesia care unit (PACU)
    End point values
    		 Intervention Control
    Number of subjects analysed
    57
    63
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    5 (0 to 10)
    10 (0 to 16.5)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Cumulative opioid consumption (IV morphine)

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    End point title
    		 Cumulative opioid consumption (IV morphine)
    End point description
    End point type
    Secondary
    End point timeframe
    within the first six hours after arrival at the PACU
    End point values
    		 Intervention Control
    Number of subjects analysed
    57
    63
    Units: milligram(s)
        median (inter-quartile range (Q1-Q3))
    5 (0 to 14)
    11 (3.9 to 17)
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.036
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 6 hours after arrival at the PACU
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 120 (0.83%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 120 (20.00%)
    Injury, poisoning and procedural complications
    Perforation of the uterus
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Perforation of the bladder
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Lesion of the intestine
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Eye disorders
    Blurred vision
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea/vomiting
         subjects affected / exposed
    14 / 120 (11.67%)
         occurrences all number
    14
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Apnea
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Itching
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Facial swelling
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    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
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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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