Ultrasonic Morphological Study of the Great Auricular Nerve and Adjacent Structures

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Xin Jiang, MD，Shanghai Changzheng Hospital

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Success rate of identification of the great auricular nerve combining ultrasound imaging with transcutaneous nerve stimulation[ Time Frame: 1 year ]

Proportion of patients who's great auricular nerve was identified by combining ultrasound imaging with transcutaneous nerve stimulation

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Difference in gender[ Time Frame: 1 year ]
Patients were divided into two groups according to whether they recognized the great auricular nerve or not, and the differences in gender composition were compared.
Difference in BMI[ Time Frame: 1 year ]
Patients were divided into two groups according to whether they recognized the great auricular nerve or not, and the differences in BMI were compared.
Difference in body fat rate[ Time Frame: 1 year ]
Patients were divided into two groups according to whether they recognized the great auricular nerve or not, and the differences in body fat rate were compared.
Difference in neck circumference[ Time Frame: 1 year ]
Patients were divided into two groups according to whether they recognized the great auricular nerve or not, and the differences in neck circumference were compared.
Success rate of identification of the great auricular nerve by ultrasound[ Time Frame: 1 year ]
Proportion of patients who's great auricular nerve was identified by ultrasound
Distance between GAP and M[ Time Frame: 1 year ]
the distance between the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle and the midpoint of posterior border of the sternocleidomastoid muscle
SCM length[ Time Frame: 1 year ]
length of the posterior border of the sternocleidomastoid muscle

Descriptive Information

Brief Title ^ICMJE

Ultrasonic Morphological Study of the Great Auricular Nerve and Adjacent Structures

Official Title ^ICMJE

Morphological Study of the Great Auricular Nerve and Adjacent Structures by Ultrasound Imaging and Transcutaneous Nerve Stimulation

Brief Summary

Ultrasound-guided nerve block has the characteristics of high success rate, few complications, and high patient satisfaction. It has been widely used in brachial plexus and lumbar plexus nerve blocks. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory, and may be due to anatomic localization of the puncture site rather than real-time ultrasound guidance. The great auricular nerve is the largest branch of the superficial cervical plexus and may be identified under ultrasound. The aim of this study is to establish the success rate of identification of the great auricular nerve by combining ultrasound imaging with transcutaneous nerve stimulation. In addition, we will study the relationship between the success rate of identification and the related factors of patients. Another purpose of this study is to locate the position where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle. The relationship between this point and the midpoint of posterior border of the sternocleidomastoid muscle and adjacent structures will also be studied.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

300

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patients undergoing surgery in changzheng hospital Exclusion Criteria: - Suffering from malignant tumors, poor overall condition - Communication barriers, unable to objectively describe symptoms - Huge mass in the neck

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Xin Jiang, MD，Shanghai Changzheng Hospital

Study Sponsor ^ICMJE

Xin Jiang, MD

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Shanghai Changzheng Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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