Ultrasound-guided Precise Superficial Cervical Plexus Block

A Randomized Controlled Clinical Trial of Ultrasound-guided Superficial Cervical Plexus Block Positioned by the Great Auricular Nerve or Conventional Landmark Technique

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

Study Overview

• Status: Unknown
• Conditions: Superficial Cervical Plexus Block
• Intervention / Treatment: Procedure: Conventional landmark technique; Procedure: Precise block 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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Changzheng hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Conventional landmark technique; inject at the midpoint of the posterior border of the sternocleidomastoid muscle
Experimental: 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	Procedure: Precise block technique; inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of block success rate in each group	Sensory blockade of the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves was graded according to a 3-point scale using a pinprick test: 2 = no block, 1 = analgesia (patient can feel touch, not pain), 0 = anesthesia (patient cannot feel touch). We considered a block to be successful if, at 15 mins, a score of 0 or 1 was achieved for each of the 4 nerves.	up to 15minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of onset time of success block in each group	onset time means time interval from completion of injection to block score of 0(patient cannot feel touch) or 1(patient can feel touch, not pain)	up to 15minutes
Comparison of pain score after surgery at PACU in each group	Use NRS score to assess pain level, The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 means no pain, 1-3 means mild pain, 4-6 means moderate pain, 7-10 means severe pain.	Day of surgery, Arrival time of PACU

Collaborators and Investigators

• Sponsor: Xin Jiang, MD
• Investigators: Principal Investigator: Xin Jiang, M.D, Changzheng hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 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

• Keywords: ultrasound guidance; great auricular nerve; sternocleidomastoid muscle
• Other Study ID Numbers: CHANGZHENG2018-19

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