Ultrasound-guided Precise Superficial Cervical Plexus Block

NCT ID: NCT03695211

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-06-30

Brief Summary

This prospective, randomized, observer-blinded study compared ultrasound-guided superficial cervical plexus block positioned by the great auricular nerve or conventional landmark technique.

Detailed Description

Ultrasound guidance has become a reliable adjunct for brachial plexus, femoral, and sciatic nerve blocks. Furthermore, US can also be used to anesthetize purely sensory nerves such as the lateral femoral cutaneous and saphenous nerves. The superficial cervical plexus (SCP), a sensory neural plexus, supplies the skin overlying the ear, neck, angle of the mandible, shoulder, and clavicle. Traditionally, the SCP is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle. Unlike brachial plexus, sciatic nerve, etc., the SCP often cannot be displayed directly under ultrasound. The purpose of ultrasound guidance was to inject the local anesthetic solution into the correct intermuscular plane between the sternocleidomastoid and scalene muscles. In previous studies, the midpoint of the posterior border of the sternocleidomastoid muscle was often selected as the puncture point. Studies of ultrasound-guided superficial cervical plexus block are mostly unsatisfactory. Ultrasound guidance does not increase the success rate of SCP block compared with traditional technique.

The conventional landmark ultrasound guidance technique (LM group) selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point, but the anatomical difference of the individual cannot be considered. It may be the reason why ultrasound guidance cannot improve the success rate of the SCP block.

The great auricular nerve is the largest branch of the SCP and can be identified under ultrasound. This study intends to indirectly locate the SCP by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). The method of precise SCP block at GAN Point under ultrasound guidance (GAN Group) was explored and compared with the LM Group.

Conditions

Superficial Cervical Plexus Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LM group

LM group use conventional landmark technique, which selects the midpoint of the posterior border of the sternocleidomastoid muscle as the puncture point of superficial cervical plexus block

Group Type: ACTIVE_COMPARATOR

Conventional landmark technique

Intervention Type: PROCEDURE

inject at the midpoint of the posterior border of the sternocleidomastoid muscle

GAN Group

This group firstly locate the superficial cervical plexus by ultrasound scanning of the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle (GAN Point). GAN Group apply the precise block technique, selects the GAN Point as the puncture point of superficial cervical plexus block

Group Type: EXPERIMENTAL

Precise block technique

Intervention Type: PROCEDURE

inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle

Interventions

Conventional landmark technique

inject at the midpoint of the posterior border of the sternocleidomastoid muscle

Intervention Type: PROCEDURE

Precise block technique

inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
• Patients undergoing neck and shoulder surgery

Exclusion Criteria

• Communication barriers, unable to objectively describe symptoms
• Nerve block contraindicated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xin Jiang, MD

OTHER

Sponsor Role: lead

Responsible Party

Xin Jiang, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Jiang, M.D

Role: PRINCIPAL_INVESTIGATOR

Changzheng Hospital

Locations

Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongbin Yuan, M.D

Role: CONTACT

jfjczyy@163.com

86-21-81885821

Facility Contacts

Hongbin Yuan, M.D

Role: primary

jfjczyy@163.com

86-21-81885821

Other Identifiers

CHANGZHENG2018-19

Identifier Type: -

Identifier Source: org_study_id