- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692156
Ultrasonic Morphological Study of the Great Auricular Nerve and Adjacent Structures
December 29, 2019 updated by: Xin Jiang, MD
Morphological Study of the Great Auricular Nerve and Adjacent Structures by Ultrasound Imaging and Transcutaneous Nerve Stimulation
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200003
- Recruiting
- Changzheng hospital
-
Contact:
- Hongbin Yuan, M.D
- Phone Number: 86-21-81885821
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-
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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who underwent surgery in our hospital during the study, especially neck surgery, such as cervical surgery, thyroid surgery, and carotid endarterectomy.
Description
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
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 |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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
|
1 year
|
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
|
1 year
|
SCM length
Time Frame: 1 year
|
length of the posterior border of the sternocleidomastoid muscle
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2019
Primary Completion (ANTICIPATED)
March 30, 2020
Study Completion (ANTICIPATED)
May 31, 2020
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (ACTUAL)
October 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 29, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CHANGZHENG2018-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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