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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block with EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair

    Summary
    EudraCT number
    		 2015-005228-24
    Trial protocol
    		 BE   DK  
    Global end of trial date
    07 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Apr 2021
    First version publication date
    10 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    402-C-327
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02713230
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pacira Pharmaceuticals, Inc.
    Sponsor organisation address
    5 Sylvan Way, Parsippany, United States, 07054
    Public contact
    Clinical Research Director, Pacira Pharmaceuticals, Inc., +1 855-793-9727 , medinfo@pacira.com
    Scientific contact
    Clinical Research Director, Pacira Pharmaceuticals, Inc., +1 855-793-9727 , medinfo@pacira.com
    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
    07 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the magnitude and duration of the analgesic effect achieved following single-dose injection brachial plexus block with EXPAREL in subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair.
    Protection of trial subjects
    Initially, unblinded review of the data and a relative risk analysis were to be conducted if any of the following, based on the incidence rate, were identified during blinded data review: -Severe or serious AE of special interest (AESI), including cardiac AESI and neurologic AESI exceeding 5% and in at least 5 subjects -Severe dizziness exceeding 10% or in at least 5 subjects -Severe AEs or serious AEs (SAEs), regardless of relationship to study drug, exceeding 20% or in at least 10 subjects If the risk relative to placebo was greater than 2, the study was to be either permanently stopped or the study eligibility criteria were to be revised to exclude subjects who were at a higher risk for a particular AE. After review of the Study Stopping Rules with the FDA (05-Jan-2017), these were changed as follows: -Incidence rate of severe or serious AESIs as defined by the protocol including cardiac AESIs and neurologic AESIs exceeding 5% or in at least 5 subjects -Incidence rate of severe dizziness exceeding 10% or in at least 5 subjects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 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
    Belgium: 19
    Country: Number of subjects enrolled
    Denmark: 21
    Country: Number of subjects enrolled
    United States: 115
    Worldwide total number of subjects
    155
    EEA total number of subjects
    40
    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)
    103
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between May 9, 2016 and July 7, 2017 at 16 sites in the US and Europe.

    Pre-assignment
    Screening details
    		 "Started" does not include one patient who was a screen failure, was not enrolled, and was randomized to placebo in error.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EXPAREL 133 mg
    Arm description
    		 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXPAREL
    Investigational medicinal product code
    Other name
    bupivacaine liposome injectable suspension
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    EXPAREL 133 mg 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Arm title
    		 EXPAREL 266 mg
    Arm description
    		 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXPAREL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Arm title
    		 Placebo
    Arm description
    		 20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Number of subjects in period 1
    		EXPAREL 133 mg EXPAREL 266 mg Placebo
    Started
    69
    15
    71
    Completed
    68
    15
    71
    Not completed
    1
    0
    0
         Physician decision
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EXPAREL 133 mg
    Reporting group description
    		 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    EXPAREL 266 mg
    Reporting group description
    		 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    Placebo
    Reporting group description
    		 20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group values
    		 EXPAREL 133 mg EXPAREL 266 mg Placebo Total
    Number of subjects
    		 69 15 71 155
    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
    Safety population included all participants who received study drug, with analysis by actual treatment received.
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ± 9.94 61.4 ± 7.73 58.5 ± 9.48 -
    Gender categorical
    Units: Subjects
        Female
    		 25 7 23 55
        Male
    		 44 8 48 100
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 0 5 8
        Not Hispanic or Latino
    		 64 15 65 144
        Unknown or Not Reported
    		 2 0 1 3
    Dominant hand
    Units: Subjects
        Left hand
    		 10 1 10 21
        Right hand
    		 59 14 61 134
    American Society of Anesthesiologists classification
    Measure Description: American Society of Anesthesiologists (ASA) classification was determined by physicians using the ASA Physical Status Classification System which assesses the patient's pre-anesthesia medical co-morbidities. ASA 1 patients would be considered a normal, healthy patient. ASA 2 is a patient with mild systemic disease (eg, smoker, well controlled diabetes or high blood pressure (HBP)). ASA 3 is a patient with severe systemic disease (eg poorly controlled diabetes or HBP). ASA 4 is a patient with severe systemic disease that is a constant threat to life (eg, recent myocardial i
    Units: Subjects
        ASA 1
    		 15 1 14 30
        ASA 2
    		 36 9 37 82
        ASA 3
    		 18 5 20 43
        ASA >/= 4
    		 0 0 0 0
    Nerve block type
    Units: Subjects
        Interscalene
    		 67 15 70 152
        Supraclavicular
    		 2 0 1 3
    Type of surgery
    Units: Subjects
        Rotator Cuff Surgery
    		 50 7 55 112
        Total Shoulder arthroplasty
    		 19 8 16 43
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 13 4 15 32
        White
    		 53 11 54 118
        More than one race
    		 0 0 0 0
        Unknown or not reported
    		 2 0 2 4
    Visual Analog Scale Pain Score
    Measure Description: Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now."
    Units: score on scale
        arithmetic mean (standard deviation)
    		 2.43 ± 2.621 2.51 ± 2.641 2.94 ± 2.514 -

    End points

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    End points reporting groups
    Reporting group title
    EXPAREL 133 mg
    Reporting group description
    		 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    EXPAREL 266 mg
    Reporting group description
    		 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    Placebo
    Reporting group description
    		 20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Primary: Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores

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    End point title
    		 Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores [1]
    End point description
    AUC of VAS pain intensity scores through 48 hours, which represents total pain experienced through 48 hours. VAS is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now."
    End point type
    Primary
    End point timeframe
    0-48 hours
    Notes
    [1] - 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: Under protocol amendment 2, the study arm 266 mg dose of EXPAREL was removed from randomization scheme and efficacy endpoints.
    End point values
    		 EXPAREL 133 mg Placebo
    Number of subjects analysed
    69
    71
    Units: cm*hr
        least squares mean (standard error)
    136.431 ± 12.090
    254.119 ± 11.768
    Statistical analysis title
    		 statistical analysis 1
    Comparison groups
    EXPAREL 133 mg v Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LSMD
    Point estimate
    -117.688
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -150.896
         upper limit
    		 -84.48

    Secondary: Total Postsurgical Opioid Consumption Through 48 Hours

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    End point title
    		 Total Postsurgical Opioid Consumption Through 48 Hours [2]
    End point description
    Total postsurgical opioid consumption (converted to IV morphine equivalents) through 48 hours
    End point type
    Secondary
    End point timeframe
    0-48 hours
    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: Under protocol amendment 2, the study arm 266 mg dose of EXPAREL was removed from randomization scheme and efficacy endpoints.
    End point values
    		 EXPAREL 133 mg Placebo
    Number of subjects analysed
    69
    71
    Units: mg
        least squares mean (standard error)
    25.007 ± 5.350
    109.739 ± 22.972
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    EXPAREL 133 mg v Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LSM treatment ratio
    Point estimate
    0.228
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.126
         upper limit
    		 0.411

    Secondary: Percentage of Opioid-free Participants Through 48 Hours

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    End point title
    		 Percentage of Opioid-free Participants Through 48 Hours [3]
    End point description
    Percentage of participants who did not receive opioid medication through 48 hours
    End point type
    Secondary
    End point timeframe
    0-48 hours
    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: Under protocol amendment 2, the study arm 266 mg dose of EXPAREL was removed from randomization scheme and efficacy endpoints.
    End point values
    		 EXPAREL 133 mg Placebo
    Number of subjects analysed
    69
    71
    Units: participants
    9
    1
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    EXPAREL 133 mg v Placebo
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 treatment difference
    Point estimate
    0.116
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.032
         upper limit
    		 0.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to postsurgical day 29
    Adverse event reporting additional description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about ca
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    EXPAREL 133 mg
    Reporting group description
    		 10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    EXPAREL 266 mg
    Reporting group description
    		 20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Reporting group title
    Placebo
    Reporting group description
    		 20 mL normal saline as single-injection brachial plexus block (interscalene or supraclavicular) ≥1 h preoperatively

    Serious adverse events
    		 EXPAREL 133 mg EXPAREL 266 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 15 (6.67%)
    1 / 71 (1.41%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 15 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 15 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 15 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 EXPAREL 133 mg EXPAREL 266 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 69 (79.71%)
    11 / 15 (73.33%)
    55 / 71 (77.46%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 69 (2.90%)
    3 / 15 (20.00%)
    6 / 71 (8.45%)
         occurrences all number
    2
    3
    6
    Hypotension
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 15 (6.67%)
    2 / 71 (2.82%)
         occurrences all number
    1
    1
    2
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 15 (6.67%)
    9 / 71 (12.68%)
         occurrences all number
    2
    1
    10
    Headache
         subjects affected / exposed
    7 / 69 (10.14%)
    1 / 15 (6.67%)
    3 / 71 (4.23%)
         occurrences all number
    7
    1
    3
    Dysgeusia
         subjects affected / exposed
    6 / 69 (8.70%)
    0 / 15 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    6
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    6 / 69 (8.70%)
    0 / 15 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    7
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 15 (6.67%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    1
    Sensory loss
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences all number
    2
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 69 (8.70%)
    1 / 15 (6.67%)
    3 / 71 (4.23%)
         occurrences all number
    6
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    17 / 69 (24.64%)
    3 / 15 (20.00%)
    26 / 71 (36.62%)
         occurrences all number
    19
    3
    27
    Constipation
         subjects affected / exposed
    6 / 69 (8.70%)
    2 / 15 (13.33%)
    9 / 71 (12.68%)
         occurrences all number
    6
    2
    9
    Vomiting
         subjects affected / exposed
    4 / 69 (5.80%)
    1 / 15 (6.67%)
    7 / 71 (9.86%)
         occurrences all number
    4
    1
    7
    Dyspepsia
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 15 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    1
    0
    4
    Abdominal pain
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 69 (4.35%)
    1 / 15 (6.67%)
    11 / 71 (15.49%)
         occurrences all number
    3
    1
    11
    Rash
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 15 (6.67%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences all number
    2
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 15 (6.67%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    5 / 69 (7.25%)
    2 / 15 (13.33%)
    8 / 71 (11.27%)
         occurrences all number
    6
    2
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2016
    Amendment 1
    14 Nov 2016
    Amendment 2

    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
    For support, Contact us.
    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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