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    Clinical Trial Results:
    The effect of the popliteal plexus block on postoperative pain after reconstruction of the anterior cruciate ligament

    Summary
    EudraCT number
    		 2017-001708-31
    Trial protocol
    		 DK  
    Global end of trial date
    04 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2019
    First version publication date
    11 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Protokol_PPB_ACL_21042017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03130049
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle-Juul Jensen Boulevard, Aarhus N, Denmark, 8200
    Public contact
    Sponsor Thomas Fichtner Bendtsen, Aarhus University Hospital Bedøvelse og operation Nord, +45 51542997, tfb@dadlnet.dk
    Scientific contact
    Sponsor Thomas Fichtner Bendtsen, Aarhus University Hospital Bedøvelse og operation Nord, +45 51542997, tfb@dadlnet.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
    05 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this pilot study is to investigate the effect of the popliteal plexus block (PPB) as a supplement to femoral triangle block (FTB) after reconstruction of the anterior cruciate ligament.
    Protection of trial subjects
    Prior to start, approval was obtained by the Danish Medicines Agency (EudraCT 2017-001708-31), the Central Denmark Region Committees on Health Research Ethics (1-10-72-100-17), the Danish Data Protection Agency (1-16-02-808-17). Registration was done in the Clinical Trials (NCT03130049) database. The trial was monitored by the Good Clinical Practice Unit and trial was conducted according to the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Sep 2017
    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
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between October and December 2017, and a total of 15 patients were enrolled at the Departments of Day Surgery at Aarhus University Hospital and Horsens Regional Hospital, Denmark. Written, informed consent was obtained from all subjects. Inclusion criteria were patients 18 years or older undergoing primary ACLR with Am

    Pre-assignment
    Screening details
    		 Patients were screened at Aarhus University and Horsens Regional Hospital. 26 patients were screened in total (10 at Aarhus University Hospital and 16 at Horsens Regional Hospital. 15 patients were enrolled and completed the trial. In and exclusion criteria were assesssed according to the protocol.

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Number of subjects completed
    		 15

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an observational pilot study with no randomization and no blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention group
    Arm description
    		 The intervention was an active popliteal plexus block. The patients scored their pain on the NRS from 0-10 on arrival at the post-anesthesia care unit (PACU) and every 15 minutes for up to 60 minutes, which was the maximal length of the postoperative observation period. When any reported pain score was NRS 4 or above, the patient received a popliteal plexus block.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine-epinephrine
    Investigational medicinal product code
    Other name
    Marcaine-adrenaline
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The patients received a popliteal plexus block with 10 ml marcaine 5 mg/ml with adrenaline 5 microgram/ml.

    Arm title
    		 No intervention group
    Arm description
    		 If the patient did not develop pain of 4 or above on the NRS in the postoperative observation period (60 minutes), the patient would not receive the intervention (popliteal plexus block).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Intervention group No intervention group
    Started
    11
    4
    Completed
    11
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.7 ± 6.2 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 13 13
    BMI
    Body mass index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.1 ± 5.4 -

    End points

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    End points reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    		 The intervention was an active popliteal plexus block. The patients scored their pain on the NRS from 0-10 on arrival at the post-anesthesia care unit (PACU) and every 15 minutes for up to 60 minutes, which was the maximal length of the postoperative observation period. When any reported pain score was NRS 4 or above, the patient received a popliteal plexus block.

    Reporting group title
    No intervention group
    Reporting group description
    		 If the patient did not develop pain of 4 or above on the NRS in the postoperative observation period (60 minutes), the patient would not receive the intervention (popliteal plexus block).

    Primary: PPB success

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    End point title
    		 PPB success [1] [2]
    End point description
    The success of the popliteal plexus block (PPB) on postoperative pain after anterior cruciate ligament repair (ACLR) defined as the number of patients with NRS > 3 dropping to af NRS of 3 or below after receiving PPB.
    End point type
    Primary
    End point timeframe
    60 minutes observation period after PPB performance.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a small unblinded, non-randomized observational pilot study. We report the only the median values for the NRS scores 30 and 60 minutes after PPB and have not applied any statistical test for this outcome.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint can only be assessed for patients receiving PPB (intervention group)
    End point values
    		 Intervention group
    Number of subjects analysed
    11
    Units: NRS 0-10
    median (inter-quartile range (Q1-Q3))
        NRS 30 min after PPB
    3 (2 to 3)
        NRS 60 min after PPB
    2 (0 to 2)
    No statistical analyses for this end point

    Secondary: Pain after ACLR

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    End point title
    		 Pain after ACLR
    End point description
    The number of patients with a femoral triangle block (FTB) who develop significant pain in the observation period (NRS>3). Only patients with NRS > 3 would then received a PPB.
    End point type
    Secondary
    End point timeframe
    60 minutes after arrival at the PACU
    End point values
    		 Intervention group No intervention group
    Number of subjects analysed
    11
    4
    Units: NRS 0-10
        Patients with NRS > 3
    11
    0
        Patients with NRS ≤ 3
    0
    4
    No statistical analyses for this end point

    Secondary: Effect of PPB on cutaneous sensation

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    End point title
    		 Effect of PPB on cutaneous sensation [3]
    End point description
    Sensation is graded on a 3-point scale: 0 = no sensation; 1 = reduced sensation; 2 = normal sensation
    End point type
    Secondary
    End point timeframe
    60 minutes after PPB placement
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint can only be assessed for patients receiving PPB (intervention group)
    End point values
    		 Intervention group
    Number of subjects analysed
    11
    Units: 0-2
        No sensation (=0)
    2
        Reduced sensation (=1)
    2
        Normal sensation (=2)
    7
    No statistical analyses for this end point

    Secondary: The effect of PPB on muscle strength

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    End point title
    		 The effect of PPB on muscle strength [4]
    End point description
    Muscle strength of ankle dorsal and plantar flexion measured with a handheld dynamometer.
    End point type
    Secondary
    End point timeframe
    Baseline and 60 minutes after PPB
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint can only be assessed for patients receiving PPB (intervention group)
    End point values
    		 Intervention group
    Number of subjects analysed
    11
    Units: Newton
    median (inter-quartile range (Q1-Q3))
        Dorsal flexion: 60 min after PPB
    114 (96 to 140)
        Plantar flexion: 60 min after PPB
    136 (114 to 176)
        Dorsal flexion: baseline
    140 (114 to 202)
        Plantar flexion: baseline
    211 (165 to 228)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    End of the observation period (60 minutes after arrival at the PACU for patients not receiving PPB and 60 minutes after PPB placement for patients receiving PPB)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    		 The intervention was an active popliteal plexus block. The patients scored their pain on the NRS from 0-10 on arrival at the post-anesthesia care unit (PACU) and every 15 minutes for up to 60 minutes, which was the maximal length of the postoperative observation period. When any reported pain score was NRS 4 or above, the patient received a popliteal plexus block.

    Reporting group title
    No intervention group
    Reporting group description
    		 If the patient did not develop pain of 4 or above on the NRS in the postoperative observation period (60 minutes), the patient would not receive the intervention (popliteal plexus block).

    Serious adverse events
    		 Intervention group No intervention group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (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
    		 Intervention group No intervention group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    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: The observation period was very short - 60 minutes. The patients were all young and healthy patients (ASA I) undergoing ACL repair and they did not experience any non-serious adverse events in the 60 minutes observation period.

    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.
    Observational pilot study - no randomization and blinding
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