Neck Anatomy and Phrenic Nerve Palsy After BPB

August 22, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes after the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before induction, 1-2 minutes
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.
Before induction, 1-2 minutes
Height
Time Frame: At admission, 1-2 minutes
Height (cm)
At admission, 1-2 minutes
Weight
Time Frame: At admission, 1-2 minutes
Weight (kg)
At admission, 1-2 minutes
Sex
Time Frame: At admission, 1-2 minutes
Sex
At admission, 1-2 minutes
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)
During brachial plexus block, 10 minutes
The volume (dose) of local anesthetics injected
Time Frame: During brachial plexus block, 10 minutes
The volume (dose) of local anesthetics injected
During brachial plexus block, 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, M.D, Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2102-133-1199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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