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
CRIS Registration Number |
KCT0004638 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Konyang University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Konyang University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M75.9)Shoulder lesion, unspecified Rotator cuff disorder |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2023. 6 |
Way of Sharing | Available on Request
(sj1825@naver.com) |
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