Skip to main content
OpenTrials
Completed

NCT Number: NCT04783064

Neck Anatomy and Phrenic Nerve Palsy After BPB

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diaphragm; Paralysis Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene brachial plexus block

Procedure

Interscalene brachial plexus block is performed at ipsilateral side of the affected shoulder.

Primary outcomes

  1. Phrenic nerve palsy

    Time frame: 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 outcomes

  1. Neck length

    Time frame: 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.

  2. Neck girth

    Time frame: 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.

  3. Height

    Time frame: At admission, 1-2 minutes

    Height (cm)

  4. Weight

    Time frame: At admission, 1-2 minutes

    Weight (kg)

  5. Sex

    Time frame: At admission, 1-2 minutes

    Sex

  6. The method of brachial plexus block

    Time frame: 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)

  7. The volume (dose) of local anesthetics injected

    Time frame: During brachial plexus block, 10 minutes

    The volume (dose) of local anesthetics injected

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Association Between Anatomic Characteristics of Neck and Diaphragmatic Palsy After Brachial Plexus Block: A Prospective Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.