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UItrasound-guided teres minor plane block of the axillary nerve

Status Approved

  • First Submitted Date

    2018/07/04

  • Registered Date

    2018/07/13

  • Last Updated Date

    2018/07/11

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
    KCT0002999
    Unique Protocol ID KC14OISI0830
    Public/Brief Title Ultrasound-guided axillary nerve block: a comparative study of interfascial injection and perivascular injection
    Scientific Title UItrasound-guided teres minor plane block of the axillary nerve
    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 KC14OISI0830
    Approval Date 2015-01-06
    Institutional Review Board Name Seoul St. Mary's Hospital, Clinical Research Coordinating Center
    Institutional Review Board Address 222, Banpo-daero, Seocho-gu, Seoul
    Institutional Review Board Telephone 02-2258-8202
    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 Young Hoon Kim
    Title Assistant professor
    Telephone +82-2-2258-6231
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea
    Contact Person for Public Queries
    Name Young Hoon Kim
    Title Assistant professor
    Telephone +82-2-2258-6231
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea
    Contact Person for Updating Information
    Name Young Hoon Kim
    Title Assistant professor
    Telephone +82-2-2258-6231
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea
  • 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 Completed
    Date of First Enrollment 2015-03-20 Actual
    Target Number of Participant 56
    Primary Completion Date 2018-01-05 , Actual
    Study Completion Date 2018-01-05 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2015-03-20 ,
  • 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 The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
    Project ID KC14OISI0830
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Suprascapular nerve block and axillary nerve block have been introduced as alternatives to the interscalene brachial plexus block for the control of postoperative pain. Ultrasound-guided procedures are widely used in regional anaesthesia, and Rothe et al.demonstrated a method of ultrasound-guided block of the axillary nerve in which the block needle is inserted just cranial to the posterior circumflex humeral artery (PCHA). However, in clinical practice, two or more vessels can be observed when the user is searching for the PCHA under ultrasound guidance. In addition, variation in the origin of the PCHA is common and it sometimes follows an abnormal course. Patients with shoulder pain were allocated to one of two groups to receive ultrasound-guided axillary nerve block with either interfascial injection (IF Group) or perivascular injection with nerve stimulation (PV Group). The primary outcome was procedure duration, defined as the time interval from when the transducer contacted the skin to when the needle was removed from the skin. PCHA visibility, the number of visualised vessels, the appearance of conical structures, intravascular uptake of contrast material, and motor and sensory functions were evaluated as the secondary outcomes. We hypothesised that interfascial injection between the deltoid and teres minor muscle would reduce the time required to perform axillary nerve block and was as effective as perivascular injection.
  • 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
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    Patients were prepared in a sitting position, with the shoulder resting in a neutral position. The areas of injection were disinfected with povidone-iodine on a posterior aspect of the shoulder. Using a high-frequency linear transducer (13–5 MHz, EDGE ultrasound device, SonoSite Inc., Bothell, WA, USA), the neck and shaft of the humerus, the deltoid muscle, and the cross-section of the teres minor muscle and the posterior circumflex humeral artery were identified, parallel to the longitudinal axis of the shaft of the humerus. The block needle (UniPlex NanoLine cannula with facet tip 22 G 100 mm; Pajunk, Geisingen, Germany) was inserted from the cranial end of the transducer. Using the in-plane technique, the needle was advanced until its tip entered the interfascial space between the deltoid muscle and the teres minor muscle. Or, the needle tip was placed just cranial to the posterior circumflex humeral artery. Interfascial plane block was confirmed in the posteroanterior fluoroscopic view after injecting 3 mL contrast material (IOBRIX, 300 mgI/mL; Taejoon Pharm, Seoul, Korea). After the contrast material dispersed in the interfascial space between the deltoid muscle and the teres minor muscle without intravascular uptake, 8 mL 2% lidocaine was slowly injected with aspiration for every 2 mL injected. If vascular uptake was detected, the process was repeated after changing the needle position.
    Number of Arms 2
    Arm 1

    Arm Label

    IF Group

    Target Number of Participant

    28

    Arm Type

    Experimental

    Arm Description

    Patients were prepared in a sitting position, with the shoulder resting in a neutral position. The areas of injection were disinfected with povidone-iodine on a posterior aspect of the shoulder. Using a high-frequency linear transducer (13–5 MHz, EDGE ultrasound device, SonoSite Inc., Bothell, WA, USA), the neck and shaft of the humerus, the deltoid muscle, and the cross-section of the teres minor muscle and the posterior circumflex humeral artery were identified, parallel to the longitudinal axis of the shaft of the humerus. The block needle (UniPlex NanoLine cannula with facet tip 22 G 100 mm; Pajunk, Geisingen, Germany) was inserted from the cranial end of the transducer. Using the in-plane technique, the needle was advanced until its tip entered the interfascial space between the deltoid muscle and the teres minor muscle. Interfascial plane block was confirmed in the posteroanterior fluoroscopic view after injecting 3 mL contrast material (IOBRIX, 300 mgI/mL; Taejoon Pharm, Seoul, Korea). After the contrast material dispersed in the interfascial space between the deltoid muscle and the teres minor muscle without intravascular uptake, 8 mL 2% lidocaine was slowly injected with aspiration for every 2 mL injected. If vascular uptake was detected, the process was repeated after changing the needle position.
    Arm 2

    Arm Label

    PV Group

    Target Number of Participant

    28

    Arm Type

    Active comparator

    Arm Description

    The patients were prepared in the manner described above. Axillary nerve block using the perivascular approach was performed using the method described by Rothe et al. Ultrasound images were obtained in the same manner as described for the IF Group. Next, the block needle (UniPlex NanoLine cannula with facet tip 22 G 100 mm; Pajunk, Geisingen, Germany) was inserted from the cranial end of the transducer and the needle tip was placed just cranial to the posterior circumflex humeral artery. When deltoid muscle contraction at a current of 0.5 mA (MultiStim VarioTM Peripheral Nerve Stimulator; Pajunk, Geisingen, Germany) was observed, 3 mL contrast material was administered. If the spread of contrast media was detected without intravascular uptake, 8 mL 2% lidocaine was slowly injected with aspiration for every 2 mL injected. If vascular uptake was detected, the needle was repositioned.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M25.51)Pain in joint, shoulder region 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~80Year

    Description

    patients with shoulder pain
    Exclusion Criteria
    1. allergies or contraindications to local anaesthetics or contrast media
    2. local infection
    3. coagulopathy 
    4. limited range of motion related to the deltoid muscle
    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
    procedure duration
    Timepoint
    during procedure
    Secondary Outcome(s) 1
    Outcome
    posterior circumflex humeral artery visibility
    Timepoint
    during procedure
    Secondary Outcome(s) 2
    Outcome
    the number of visualised vessels
    Timepoint
    during procedure
    Secondary Outcome(s) 3
    Outcome
    the appearance of conical structures
    Timepoint
    during procedure
    Secondary Outcome(s) 4
    Outcome
    intravascular uptake of contrast material
    Timepoint
    during procedure
    Secondary Outcome(s) 5
    Outcome
    Deltoid motor function
    Timepoint
    Before procedure, 15 min and 30 min after procedure
    Secondary Outcome(s) 6
    Outcome
    sensory function
    Timepoint
    Before procedure, 15 min and 30 min after procedure
  • 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 Yes
    Results Upload
    Final Enrollment Number 56
    Number of Publication 0
    Results Upload results.pdf
    Date of Posting Results 2018/07/13
    Protocol URL or File Upload
    Brief Summary
    The procedure time was significantly shorter in the IF Group than in the PV Group (mean [SD]: 64 [28.3] vs. 135 [50.3] s; P < 0.001). There were no differences in the visibility of the posterior circumflex humeral artery between the groups (96.4% vs. 100%; P = 1.000). The number of visualised vessels were similar between the groups. More than two blood vessels were observed in 17 patients (60.7%) in each group. There were no significant differences in the appearance of conical structures between the groups (85.7% vs. 82.1%; P = 1.000). There were only two (7.1%) cases of intravascular uptake in the PV Group, but there were no significant differences between the groups. There were no significant differences in complications between the groups (1 [3.6%] vs. 5 [17.9%]; P = 0.193). All complications, except for one instance of radial nerve weakness in the PV Group, were resolved within 30 min. There were no significant differences between groups in the success of axillary nerve block as assessed by loss of pinprick sensation as well as the presence of motor block of the deltoid muscle when assessed 30 min after blocks.
  • 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 No
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