Diaphragm; Paralysis Clinical Trial
Official title:
Association Between Anatomic Characteristics of Neck and Diaphragmatic Palsy After Brachial Plexus Block: A Prospective Observational Study
| Verified date | August 2023 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | March 21, 2023 |
| Est. primary completion date | October 26, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia Exclusion Criteria: - Patients who refused to participate in the trial - Patients with respiratory diseases such as asthma and chronic obstructive pulmonary disease - Patients with neurological abnormalities of the upper limb - Patients with a history of surgery around the neck on the ipsilateral side of the surgery site, radiation treatment history, etc. - Patients with a history of allergy or hypersensitivity reactions to local anesthetics |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phrenic nerve palsy | Ultrasound is used to check the movement of the diaphragm on the operation side. The movement of the diaphragm is measured in centimeters when checked with M-mode in a forceful sniffing state. | 10 minutes after the end of surgery | |
| Secondary | Neck length | The neck length is measured by drawing a straight line from the mandible angle on the side to the middle point of the clavicle with a tape measure. | Before induction, 1-2 minutes | |
| Secondary | Neck girth | The neck circumference length is measured by a tape ruler over the upper plane of the spinous process of the 7th cervical spine at the back and the lower plane of the thyroid cartilage at the front side in the patient's sitting position. | Before induction, 1-2 minutes | |
| Secondary | Height | Height (cm) | At admission, 1-2 minutes | |
| Secondary | Weight | Weight (kg) | At admission, 1-2 minutes | |
| Secondary | Sex | Sex | At admission, 1-2 minutes | |
| Secondary | The method of brachial plexus block | Specific location where the brachial plexus block was performed (Specific location of needle tip where local anesthetic is injected) | During brachial plexus block, 10 minutes | |
| Secondary | The volume (dose) of local anesthetics injected | The volume (dose) of local anesthetics injected | During brachial plexus block, 10 minutes |