NCT03692156

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

January 2, 2020

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

September 27, 2018

Last Update Submit

December 29, 2019

Conditions

Keywords

sternocleidomastoid muscleSuperficial Cervical Plexus blockultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (7)

  • Difference in gender

    1 year

  • Difference in BMI

    1 year

  • Difference in body fat rate

    1 year

  • Difference in neck circumference

    1 year

  • Success rate of identification of the great auricular nerve by ultrasound

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients undergoing surgery in changzheng hospital

You may not qualify if:

  • Suffering from malignant tumors, poor overall condition
  • Communication barriers, unable to objectively describe symptoms
  • Huge mass in the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Central Study Contacts

Hongbin Yuan, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 2, 2018

Study Start

May 1, 2019

Primary Completion

March 30, 2020

Study Completion

May 31, 2020

Last Updated

January 2, 2020

Record last verified: 2019-04

Locations