Great Auricular NerveNCT03692156
Ultrasonic Morphological Study of the Great Auricular Nerve and Adjacent Structures
An observational study of Great Auricular Nerve, run by Xin Jiang, MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Great Auricular Nerve
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgery in our hospital during the study, especially neck surgery, such as cervical surgery, thyroid surgery, and carotid endarterectomy.
Who may be able to join
- Patients undergoing surgery in changzheng hospital
Who cannot join
- Suffering from malignant tumors, poor overall condition
- Communication barriers, unable to objectively describe symptoms
- Huge mass in the neck
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Hongbin Yuan, M.D, 86-21-81885821
About this study
Official title: 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.
- Conditions
- Great Auricular Nerve
- Keywords
- sternocleidomastoid muscle, Superficial Cervical Plexus block, ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of identification of the great auricular nerve combining ultrasound imaging with transcutaneous nerve stimulation
Proportion of patients who's great auricular nerve was identified by combining ultrasound imaging with transcutaneous nerve stimulation
Measured: 1 year
Secondary outcomes (7)
Difference in gender
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.
Measured: 1 year
Difference in BMI
Patients were divided into two groups according to whether they recognized the great auricular nerve or not, and the differences in BMI were compared.
Measured: 1 year
Difference in body fat rate
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.
Measured: 1 year
Difference in neck circumference
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.
Measured: 1 year
Success rate of identification of the great auricular nerve by ultrasound
Proportion of patients who's great auricular nerve was identified by ultrasound
Measured: 1 year
Distance between GAP and M
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
Measured: 1 year
SCM length
length of the posterior border of the sternocleidomastoid muscle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 May 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Great Auricular NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Jiang, MD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692156
- Sponsor's protocol ID
- CHANGZHENG2018-15
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Study of the Great Auricular Nerve and Adjacent Structures by Ultrasound Imaging and Transcutaneous Nerve Stimulation
- ClinicalTrials.gov ID
- NCT03692156
- Acronym / sponsor ID
- CHANGZHENG2018-15
- Conditions
- Great Auricular Nerve
- Keywords
- sternocleidomastoid muscle, Superficial Cervical Plexus block, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xin Jiang, MDUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery in our hospital during the study, especially neck surgery, such as cervical surgery, thyroid surgery, and carotid endarterectomy.
Key inclusion criteria (1 listed)
- Patients undergoing surgery in changzheng hospital
Key exclusion criteria (3 listed)
- Suffering from malignant tumors, poor overall condition
- Communication barriers, unable to objectively describe symptoms
- Huge mass in the neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Difference in gender
Time frame: 1 year
Difference in BMI
Time frame: 1 year
Difference in body fat rate
Time frame: 1 year
Difference in neck circumference
Time frame: 1 year
Success rate of identification of the great auricular nerve by ultrasound
Time frame: 1 year
Distance between GAP and M
Time frame: 1 year
SCM length
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Great Auricular Nerve
RecruitingPhase 2
Dexmedetomidine as an Adjuvant to Greater Auricular Nerve Block in Middle Ear Surgeries
Postoperative Pain, Middle Ear Surgery
Not yet recruitingPhase 4
Efficacy of Ultrasound-Guided Combined Greater Occipital Nerve Block and Greater Auricular Nerve Block Versus Greater Occipital Nerve Block Alone in the Management of Chronic Migraine
Chronic Migraine Headache
Recruiting
Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.
Emergence Agitation, Emergence Delirium, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Great Auricular Nerve, run by Xin Jiang, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbin Yuan, M.D (86-21-81885821, jfjczyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of identification of the great auricular nerve combining ultrasound imaging with transcutaneous nerve stimulation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.