Neck Anatomy and Phrenic Nerve Palsy After BPB

Completed

• Conditions: Diaphragm; Paralysis

• Registration Number: NCT04783064
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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. In addition, we want to identify risk factors for diaphragmatic paralysis after brachial plexus block. Through this study, we can find the basis for predicting the possibility of diaphragmatic paralysis after brachial plexus block according to the patient's anatomical characteristics and procedural factors.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-03-17
• Primary Completion: 2022-10-26
• Study Completion: 2023-03-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phrenic nerve palsy	10 minutes after the end of surgery	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.

Secondary Outcome Measures

Name	Time	Method
Height	At admission, 1-2 minutes	Height (cm)
Neck girth	Before induction, 1-2 minutes	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.
Weight	At admission, 1-2 minutes	Weight (kg)
Sex	At admission, 1-2 minutes	Sex
Neck length	Before induction, 1-2 minutes	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.
The method of brachial plexus block	During brachial plexus block, 10 minutes	Specific location where the brachial plexus block was performed (Specific location of needle tip where local anesthetic is injected)
The volume (dose) of local anesthetics injected	During brachial plexus block, 10 minutes	The volume (dose) of local anesthetics injected

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of