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    Clinical Trial Results:
    Surgical anesthesia for elective hip surgery - hemodynamic effect of lumbosacral plexus blockade compared to continuous spinal anesthesia

    Summary
    EudraCT number
    2015-003498-13
    Trial protocol
    DK  
    Global end of trial date
    24 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    09 May 2018
    First version publication date
    09 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HIP/FUSION#1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02544269
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Local health research ethics committee no.: 51392, Danish data protection agency no.: 2015-57-0002
    Sponsors
    Sponsor organisation name
    Institut for Klinisk Medicin
    Sponsor organisation address
    Noerrebrogade 44, building 22, 1st floor, Aarhus C, Denmark, 8000
    Public contact
    Niels Dalsgaard Nielsen, Institut for Klinisk Medicin, Aarhus Universitet, +45 2283 8334, nielsdn@dadlnet.dk
    Scientific contact
    Niels Dalsgaard Nielsen, Institut for Klinisk Medicin, Aarhus Universitet, +45 2283 8334, nielsdn@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 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Comparison of the hemodynamic effect of lumbosacral plexus blockade versus continuous spinal anesthesia.
    Protection of trial subjects
    Continuous hemodynamic monitoring (electrocardiogram, pulseoxymetri, invasive arterial and central venous blood pressures, heart rate, cardiac output, cardiac stroke volume, systemic vascular resistance and central venous oxygen saturation) allowed for early detection of hemodynamic adverse events. All skin punktures were preceded by subdermal infiltration with local anaesthetics (lidocaine 10 mg/mL).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jun 2016
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    4
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screened 24 patients.

    Period 1
    Period 1 title
    Pilot study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Subjects not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Lumbosacral plexus block
    Arm description
    Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard)
    Arm type
    Experimental

    Investigational medicinal product name
    Ropivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Lumbar plexus block: 20 mL ropivacain 7,5 mg/mL perineural, single injection Sacral plexus block: 10 mL ropivacain 7,5 mg/mL perineural, single injection Iliohypogastric block: 10 mL ropivacain 7,5 mg/mL perineural, single injection

    Arm title
    Continuous spinal anesthesia
    Arm description
    Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter.
    Arm type
    Active comparator

    Investigational medicinal product name
    Bupivacaine, CSA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Repeated intrathecal doses of 0,5 mL bupivacaine 5 mg/mL. Dose repeated after 10 min and subsequent doses after 5 min if spinal anesthesia had not reached a level of the iliac crest. Max cumulated dose was 3 mL/15 mg.

    Arm title
    Single-dose spinal anesthesia
    Arm description
    Surgical anesthesia with a single intrathecal injection of bupivacaine
    Arm type
    Active comparator

    Investigational medicinal product name
    Bupivacaine, SDSA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intrathecal use
    Dosage and administration details
    Single intrathecal injection of 2 mL bupivacaine 5 mg/mL through a spinal catheter.

    Number of subjects in period 1
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Started
    3
    3
    2
    Completed
    3
    2
    1
    Not completed
    0
    1
    1
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pilot study
    Reporting group description
    -

    Reporting group values
    Pilot study Total
    Number of subjects
    8 8
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    4 4
        From 65-84 years
    4 4
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67 ± 7.928 -
    Gender categorical
    Units: Subjects
        Female
    4 4
        Male
    4 4
    ASA-score
    American Society of Anesthesiologists physical status classification system
    Units: Subjects
        ASA I
    0 0
        ASA II
    8 8
        ASA III
    0 0
    Height
    Units: Centimeters
        arithmetic mean (standard deviation)
    175 ± 11.13 -
    Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    81.1 ± 18.23 -
    Charlson Comorbidity Index
    Units: Index
        median (full range (min-max))
    0 (0 to 1) -

    End points

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    End points reporting groups
    Reporting group title
    Lumbosacral plexus block
    Reporting group description
    Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard)

    Reporting group title
    Continuous spinal anesthesia
    Reporting group description
    Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter.

    Reporting group title
    Single-dose spinal anesthesia
    Reporting group description
    Surgical anesthesia with a single intrathecal injection of bupivacaine

    Primary: Change of cardiac output

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    End point title
    Change of cardiac output [1]
    End point description
    Change of cardiac output (mL/min) from baseline (before nerve block performance) to 30 minutes after nerve block.
    End point type
    Primary
    End point timeframe
    30 minutes after nerve block 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: As the trial was haltet after the pilot study only data from 6 patients in 3 groups was collected. It was not deemed meaningful to analyse on these sparse numbers.
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: percent
        arithmetic mean (full range (min-max))
    1.8 (-15.8 to 30.2)
    0.8 (0 to 1.6)
    -13.2 (-13.2 to -13.2)
    No statistical analyses for this end point

    Secondary: Time for nerve blockade performance

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    End point title
    Time for nerve blockade performance [2]
    End point description
    Duration of lumbar plexus block (LPB) and sacral plexus block (SPB) performance from beginning of ultrasound scan (after applying sterile dressing) before LPB to withdrawal of nerve block needle after SPB.
    End point type
    Secondary
    End point timeframe
    After nerve block performance
    Notes
    [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: As the trial was haltet after the pilot study only data from 6 patients in 3 groups was collected. It was not deemed meaningful to analyse on these sparse numbers.
    End point values
    Lumbosacral plexus block
    Number of subjects analysed
    3
    Units: minute
        arithmetic mean (full range (min-max))
    24 (22 to 26)
    No statistical analyses for this end point

    Secondary: Success rate of surgical anesthesia

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    End point title
    Success rate of surgical anesthesia
    End point description
    Rate (0-1) of success of surgical anesthesia.
    End point type
    Secondary
    End point timeframe
    At time of positioning of patient on operating table
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: Success rate
    0
    1
    1
    No statistical analyses for this end point

    Secondary: Cumulated peroperative dose of propofol

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    End point title
    Cumulated peroperative dose of propofol
    End point description
    Cummulated dose of intravenous propofol administered during surgery
    End point type
    Secondary
    End point timeframe
    As patient leaves the operating room
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: milligram(s)
        arithmetic mean (full range (min-max))
    183 (153 to 204)
    151 (131 to 170)
    96 (96 to 96)
    No statistical analyses for this end point

    Secondary: Cumulated peroperative dose of opioids

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    End point title
    Cumulated peroperative dose of opioids
    End point description
    Cumulated dose of intravenous opioids administered during surgery. Converted to peroral morphine equivalents.
    End point type
    Secondary
    End point timeframe
    As patient leaves the operating room
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: milligram(s)
        arithmetic mean (full range (min-max))
    13 (0 to 40)
    0 (0 to 0)
    23 (23 to 23)
    No statistical analyses for this end point

    Secondary: Cumulated postoperative does of opioids

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    End point title
    Cumulated postoperative does of opioids
    End point description
    Cumulated dose of opioid administered during the first 24 hours after surgery. Converted to peroral morphine equivalents.
    End point type
    Secondary
    End point timeframe
    24 hours after surgery
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: milligram(s)
        arithmetic mean (full range (min-max))
    81 (46 to 148)
    63 (0 to 118)
    70 (70 to 70)
    No statistical analyses for this end point

    Secondary: Time to first opioid dose

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    End point title
    Time to first opioid dose
    End point description
    Time from end of surgery to first request for opioids.
    End point type
    Secondary
    End point timeframe
    24 hours after surgery.
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    1
    1
    Units: minute
        arithmetic mean (full range (min-max))
    529 (286 to 768)
    67 (67 to 67)
    170 (170 to 170)
    No statistical analyses for this end point

    Secondary: Change of cardiac stroke volume

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    End point title
    Change of cardiac stroke volume
    End point description
    Change of cardiac stroke volume (mL) from baseline (before nerve block performance) to 30 minutes after nerve block.
    End point type
    Secondary
    End point timeframe
    30 minutes after nerve block performance
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: percent
        arithmetic mean (full range (min-max))
    6.4 (-15.6 to 30.2)
    -1.7 (-7.2 to 3.8)
    -12.3 (-12.3 to -12.3)
    No statistical analyses for this end point

    Secondary: Change of systemic vascular resistance

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    End point title
    Change of systemic vascular resistance
    End point description
    Change of systemic vascular resistance (dyne-s/cm⁵) from baseline (before nerve block performance) to 30 minutes after nerve block.
    End point type
    Secondary
    End point timeframe
    30 minutes after nerve block performance
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: percent
        arithmetic mean (full range (min-max))
    0.9 (-33.7 to 23.9)
    1.3 (-1.2 to 3.8)
    -29.4 (-29.4 to -29.4)
    No statistical analyses for this end point

    Secondary: Change of mean arterial pressure

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    End point title
    Change of mean arterial pressure
    End point description
    Change of mean arterial blood pressure (mm Hg) from baseline (before nerve block performance) to 30 minutes after nerve block.
    End point type
    Secondary
    End point timeframe
    30 minutes after nerve block performance
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: percent
        arithmetic mean (full range (min-max))
    -4.1 (-15 to 6.7)
    1 (1 to 1.1)
    -40.4 (-40.4 to -40.4)
    No statistical analyses for this end point

    Secondary: Change of central venous oxygen saturation

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    End point title
    Change of central venous oxygen saturation
    End point description
    Change of central venous oxygen saturation (%) from baseline (before nerve block performance) to 30 minutes after nerve block.
    End point type
    Secondary
    End point timeframe
    30 minutes after nerve block performance
    End point values
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Number of subjects analysed
    3
    2
    1
    Units: percent
        arithmetic mean (full range (min-max))
    3 (-8.2 to 8.7)
    3.2 (2.4 to 4.1)
    8.2 (8.2 to 8.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Pilot study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Lumbosacral plexus block
    Reporting group description
    Surgical anaesthesia with lumbosacral plexus block by a combination of the following: Lumbar plexus block (Shamrock-block as described by A. Sauter) Sacral plexus block (Parasacral parallel shift-block as described by TF. Bendtsen) Iliohypogastric block (Fascia transversalis plane block as described by P. Hubbard)

    Reporting group title
    Continuous spinal anesthesia
    Reporting group description
    Surgical anaesthesia with repeated intrathecal doses of bupivacain through a spinal catheter.

    Reporting group title
    Single-dose spinal anesthesia
    Reporting group description
    Surgical anesthesia with a single intrathecal injection of bupivacaine

    Serious adverse events
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (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: 0%
    Non-serious adverse events
    Lumbosacral plexus block Continuous spinal anesthesia Single-dose spinal anesthesia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    Vascular disorders
    Arterial hypotension
    Additional description: Arterial hypotension defined as mean arterial blood pressure below 60 mm Hg or below 35 % of baseline (whichever is the highest value).
         subjects affected / exposed [1]
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Hemorrhage and anaemia
    Additional description: Per- and postoperative bleeding with resulting anaemia
         subjects affected / exposed [2]
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
    Additional description: Occurrence of atrial fibrillation in patients with no prior history of atrial fibrillation.
         subjects affected / exposed [3]
    1 / 3 (33.33%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Paresthesia
         subjects affected / exposed [4]
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: No it's not. 3 subjects was exposed in the lumbosacral plexus block-group, 2 subjects was exposed in the continuous spinal anesthesia-group and 1 subject was exposed in the single-dose spinal anesthesia-group.

    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? Yes
    Date
    Interruption
    Restart date
    24 Feb 2017
    In an interim analysis of data from the first 6 patients, who completed the pilot study, no difference in the primary end point (change of cardiac output) was found between the two primary groups (lumbosacral plexus block and continuous spinal anesthesia). This led to doubts about the validity of the study hypothesis, which assumed a subjective difference in change of cardiac output between the two groups. It was considered to change the hypothesis according to the pilot data and thus perform a non-inferiority study. This path was abandoned, however, due to a revised sample-size estimate of 25 patients per group. It was deemed impossible both for practical and economic reasons to include a total of 50 patients. As a consequence, it was decided to terminate the trial.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Results are from a non-randomised non-blinded pilot study.
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