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The extent of blockade following neural and intrafascial injection of interscalene brachial plexus block

Status Approved

  • First Submitted Date

    2019/12/09

  • Registered Date

    2020/01/22

  • Last Updated Date

    2020/01/08

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004638
    Unique Protocol ID 2019-05-032-004
    Public/Brief Title The extent of blockade following injection method of brachial plexus block
    Scientific Title The extent of blockade following neural and intrafascial injection of interscalene brachial plexus block
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KYUH 2019-05-032-004
    Approval Date 2019-12-04
    Institutional Review Board Name Konyang University Hospital Institutional Review Board
    Institutional Review Board Address 158, Gwanjeodong-ro, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-600-9057
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Seok-jin LEE
    Title Dr.
    Telephone +82-42-600-9312
    Affiliation Konyang University Hospital
    Address Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718
    Contact Person for Public Queries
    Name Seok-jin LEE
    Title Dr.
    Telephone +82-42-600-9312
    Affiliation Konyang University Hospital
    Address Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718
    Contact Person for Updating Information
    Name Seok-jin LEE
    Title Dr.
    Telephone +82-42-600-9312
    Affiliation Konyang University Hospital
    Address Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-02-03 Anticipated
    Target Number of Participant 68
    Primary Completion Date 2020-12-31 , Anticipated
    Study Completion Date 2020-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Konyang University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-02-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Konyang University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Konyang University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Recently, the brachial plexus block has been actively performed for shoulder surgery. Brachial plexus anesthesia is used alone or in combination with general anesthesia. In particular, many cases have been practiced only by brachial plexus anesthesia for shoulder surgery using arthroscopy.
     Patients complain of pain during surgery under arthroscopy after brachial plexus anesthesia. Around the shoulder joint, the scapula nerve, the axillary nerve and the lateral pectoral nerve are dominant. The inner brachial region and the lower part of the scapula spine do not produce complete sensory blockage by only brachial plexus anesthesia. In previous Cadaver study, the path and distribution of scapula nerve, axillary nerve and the lateral pectoral nerve were checked and the area where each nerve dominates and the areas where several nerves were overlapping was turned out. The literature confirming the extent of sensory blockage around the joint with shoulder arthroscopy hasn’t been found yet. A conventional method of interscalene brachial plexus block for shoulder surgery is to inject drugs in contact with or near a nerve, or into a sheath that surrounds a nerve bundle. Among these two methods, when the drug is injected into the sheath(fascia), the drug spreads well around the nerve. Therefore, when comparing the near-nerve injection method with the intrafascial injection method, the study was planned to confirm whether the anesthesia was achieved by the intrafascial injection method can achieve a faster anesthesia time and a wider range of anesthesia was obtained.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Investigator
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    All subjects will be fasted for at least 8 hours in the same manner as patients receiving general anesthesia here, regardless of participation in this study. Oxymetry, electrocardiogram, and non-invasive blood pressure measurement should be performed in the lying position immediately after arriving operating room. Turn his or her head to the opposite side of the procedure, put a pore or pedestal under his or her back to make a posture, and prepare for disinfection and treatment.
    With view of ultrasound, C5, C6, and C7 nerve roots, or the superior, middle, and inferior trunks, which form the brachial plexus between the ribs at about 2cm above the clavicle, are identified. A 25G 5cm nerve-stimulating needle is aimed at the C5 root or superior trunk (in-plane technique) to check muscle twitching at 1.5mA, if the muscle twitching is made, stop the needle entry , and check the tremor at 0.5mA and 0.2mA to prevent intraneural injection. Make sure there is no twitching and inject 0.5% ropivacaine 25cc. If there is twitching at 0.2 mA, the needle is retracted by 1 mm until the tremor disappears and the drug is injected (group C). In the case of group I, place a needle tip in the fascia of the scalene muscle between the upper and middle trunk of the brachial plexus, and inject 0.5% ropivacaine 25cc after confirming that there is no tremor at 0.2mA. In addition, supraclavicular nerve block was administered with 0.5% ropivacaine 3cc in both groups.
    Anesthesiologists who perform anesthesia know the near-nerve injection group (Group C) and the intrafascial injection group (Group I) at the time of the procedure. The evaluation of sensory block is made by an orthopedic surgeon who performs shoulder surgery, and the surgeon does not know which group the patient belongs to.
    Number of Arms 2
    Arm 1

    Arm Label

    Intrafascial injection group

    Target Number of Participant

    34

    Arm Type

    Experimental

    Arm Description

    In the case of intrafascial injection group, the fascia of the scalene muscle surrounding the brachial plexus is confirmed by ultrasound, and the nerve-block needle penetrates the fascia and confirms that the needle is located in the fascia, and then 0.5% ropivacaine is administered.
    Arm 2

    Arm Label

    Near-nerve injection group

    Target Number of Participant

    34

    Arm Type

    Active comparator

    Arm Description

    In the case of injection near the nerve, the brachial plexus between the scalene muscle is confirmed by ultrasound and nerve stimulation, and the needle is placed near the nerve and administered 0.5% ropivacaine without penetrating the fascia of the scalene muscle.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M75.9)Shoulder lesion, unspecified 

    Rotator cuff disorder
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~65Year

    Description

    1) Patient with rotator cuff disorder undergoing arthroscopic surgery under brachial plexus anesthesia
    2) American Society of Anesthesiologist Patient Status I~III
    Exclusion Criteria
    1)Pregnancy
    2) Emergency operation 
    3) obesity (Body mass index >35kg/m2)  
    4) anticoagulant therapy 
    5) Infection of the nerve block site
    6) Unilateral diaphragmatic paralysis opposite the surgical site  
    7) psychiatric disease or cognitive disorder
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Time to get successful anesthesia for shoulder surgery
    Timepoint
    During 30 minutes after the ends of brachial plexus block procedure
    Secondary Outcome(s) 1
    Outcome
    Checking the range of sensory blockage in the shoulder joint area that can be identified through arthroscopy
    Timepoint
    For 1 hour after start of surgery
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2023. 6
    Way of Sharing Available on Request
    (sj1825@naver.com)
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