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    Clinical Trial Results:
    Continous wound infiltration after hallux valgus surgery

    Summary
    EudraCT number
    		 2013-005106-64
    Trial protocol
    		 AT  
    Global end of trial date
    30 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2020
    First version publication date
    17 Jul 2020
    Other versions
    Summary report(s)
    		 DSUR CWI-HVS

    Trial information

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    Trial identification
    Sponsor protocol code
    CWI-HVS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02182999
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Univ.Prof. Dr. Martin Krismer , Medical University Innsbruck University Hospital for Orthopaedics Anichstrasse 35 6020 Innsbruck, 43 512/504-22691, martin.krismer@tirol-kliniken.at
    Scientific contact
    Univ.Prof. Dr. Martin Krismer , Medical University Innsbruck University Hospital for Orthopaedics Anichstrasse 35 6020 Innsbruck, 43 512/504-22691, martin.krismer@tirol-kliniken.at
    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
    30 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to investigate the effect of continous wound infiltration with long-lasting local anesthetics in comparison to standard pain management after elective distal metatarsal osteotomy for postoperative pain control.
    Protection of trial subjects
    Patients received 1.3 mg hydromorphone (Hydal, Mundipharma GmbH, Vienna, Austria) as a rescue medication for NRS (numeric rating scale; 1-10, higher numbers indicating increasing pain level) pain score greater than 3.
    Background therapy
    		 For postoperative pain management, naproxen 500 mg (Naprobene; ratiopharm Arzneimittel Vertriebs-GmbH, Vienna, Austria) was administered twice a day. Patients were routinely discharged the second day after surgery and 500 mg of naproxen twice a day was prescribed for 5 days.
    Evidence for comparator
    		 Hallux valgus surgery is usually associated with significant postoperative pain, especially during the first 24 hours postoperatively. Previous studies showed that the CWI (continuous wound infiltration / infusion) of local anesthetics provides sufficient postoperative analgesia and reduces postoperative narcotic consumption without an increased risk of complications.
    Actual start date of recruitment
    03 Mar 2014
    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
    Austria: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    35
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients undergoing a distal metatarsal osteotomy and lateral release with or without concomitant osteotomy of the proximal phalanx of the greater toe (Akin osteotomy) for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017 were screened for eligibility.

    Pre-assignment
    Screening details
    		 A total of 294 osteotomies of the first metatarsal were performed for idiopathic hallux valgus deformity at the Department of Orthopedic Surgery, Medical University of Innsbruck, between May 2014 and March 2017. After screening for eligibility, 50 patients were enrolled in the study.

    Period 1
    Period 1 title
    Recruitment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    A randomization sequence was generated by computer software (http://www.randomizer.org). A randomization list from 1 to 50 was created, each number encoding for treatment or placebo group. The numbers were placed in 50 individual sealed opaque envelopes marked 1 to 50. The randomization list was stored in a locked room and could only be accessed by one independent member of the nursing staff, who prepared the study medication but did not take part in patient care.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment goup
    Arm description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropinaest®
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine 2 mg/mL (Gebro GmbH, 6391 Fieberbrunn, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Arm title
    		 Placebo group
    Arm description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiologic salt solution
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with Physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).

    Number of subjects in period 1
    		Treatment goup Placebo group
    Started
    25
    25
    Completed
    22
    20
    Not completed
    3
    5
         Dislocation of catheter
    2
    3
         Removal of catheter due to local dysesthesia
    1
    -
         Intraoperative conversion to arthrodesis
    -
    1
         Revision of catheter fixed by suture
    -
    1
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    A randomization sequence was generated by computer software (http://www.randomizer.org). A randomization list from 1 to 50 was created, each number encoding for treatment or placebo group. The numbers were placed in 50 individual sealed opaque envelopes marked 1 to 50. The randomization list was stored in a locked room and could only be accessed by one independent member of the nursing staff, who prepared the study medication but did not take part in patient care.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment goup
    Arm description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ropinaest®
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine 2 mg/mL (Gebro GmbH, 6391 Fieberbrunn, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Arm title
    		 Placebo group
    Arm description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Physiologic salt solution
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with Physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).

    Number of subjects in period 2
    		Treatment goup Placebo group
    Started
    22
    20
    Completed
    21
    18
    Not completed
    1
    2
         Wound infection and dehiscence
    -
    1
         Fracture of the first metatarsal
    1
    -
         Rupture of flexor hallucis tendon
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment goup
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Reporting group title
    Placebo group
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).

    Reporting group values
    		 Treatment goup Placebo group Total
    Number of subjects
    		 25 25 50
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 18 17 35
        From 65-84 years
    		 7 8 15
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.0 ( 13.1 ) 52.5 ( 17.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20 40
        Male
    		 5 5 10

    End points

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    End points reporting groups
    Reporting group title
    Treatment goup
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Reporting group title
    Placebo group
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).
    Reporting group title
    Treatment goup
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Reporting group title
    Placebo group
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).

    Primary: Average pain level during the first 48 hours after surgery

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    End point title
    		 Average pain level during the first 48 hours after surgery
    End point description
    The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were recorded by members of the nursing staff every 4 hours after the procedure until discharge, with the exception of the control at 4 am in the morning (16 hours, 40 hours), when most patients were asleep.
    End point type
    Primary
    End point timeframe
    Day 1- day 3
    End point values
    		 Treatment goup Placebo group
    Number of subjects analysed
    22
    20
    Units: NRS (Numeric Rating Scale)
    arithmetic mean (standard deviation)
        Average pain level
    1.9 ( 0.8 )
    2.0 ( 0.7 )
    Statistical analysis title
    		 Pain level
    Comparison groups
    Placebo group v Treatment goup
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.596
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Peak pain level during the first 48 hours after surgery

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    End point title
    		 Peak pain level during the first 48 hours after surgery
    End point description
    The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were recorded by members of the nursing staff every 4 hours after the procedure until discharge, with the exception of the control at 4 am in the morning (16 hours, 40 hours), when most patients were asleep.
    End point type
    Primary
    End point timeframe
    Day 1- day 3
    End point values
    		 Treatment goup Placebo group
    Number of subjects analysed
    22
    20
    Units: NRS (Numeric Rating Scale)
    arithmetic mean (standard deviation)
        Peak pain level
    3.5 ( 2.0 )
    3.9 ( 1.7 )
    Statistical analysis title
    		 Peak pain level
    Comparison groups
    Treatment goup v Placebo group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.353
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Rescue medicaton during the first 48 hours after surgery

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    End point title
    		 Rescue medicaton during the first 48 hours after surgery
    End point description
    Patients received 1.3 mg hydromorphone (Hydal, Mundipharma GmbH, Vienna, Austria) as a rescue medication for NRS pain score greater than 3. Mean narcotic consumption during the first 48 hours after surgery did not differ significantly between both groups, although there was a trend toward a lower need for rescue medication in the treatment group compared with the control group.
    End point type
    Secondary
    End point timeframe
    Day 1-day 3
    End point values
    		 Treatment goup Placebo group
    Number of subjects analysed
    22
    20
    Units: mg
    arithmetic mean (standard deviation)
        Rescue medication
    1.4 ( 1.7 )
    2.5 ( 2.5 )
    Statistical analysis title
    		 Rescue medication
    Comparison groups
    Treatment goup v Placebo group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.354
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    03.03.2014-30.04.2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Treatment goup
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with ropivacaine (Gebro GmbH, 6391 Fieberbrunn, Austria) 2 mg/mL to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Melsungen, Germany).

    Reporting group title
    Placebo group
    Reporting group description
    		 Continuous wound infiltration catheter was placed in the dorsomedial skin incision, connected to the filter and filled with physiologic salt solution 9 mg/mL (Fresenius Kabi Austria GmbH; Graz, Austria) to allow for CWI at a rate of 2 mL/h for 24 hours via a perfusor (Perfusor compact; B. Braun Melsungen, Germany).

    Serious adverse events
    		 Treatment goup Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Revision of catheter fixed by a suture
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of catheter due to local dysesthesia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Treatment goup Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 25 (12.00%)
    Surgical and medical procedures
    Dislocation of cathether
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 25 (12.00%)
         occurrences all number
    5
    5

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29073780
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