Ultrasound-guided Precise Superficial Cervical Plexus Block

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Xin Jiang, MD，Shanghai Changzheng Hospital

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

August 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of block success rate in each group[ Time Frame: up to 15minutes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Comparison of onset time of success block in each group[ Time Frame: up to 15minutes ]
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)
Comparison of pain score after surgery at PACU in each group[ Time Frame: Day of surgery, Arrival time of PACU ]
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.

Descriptive Information

Brief Title ^ICMJE

Ultrasound-guided Precise Superficial Cervical Plexus Block

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomize, double blind, prospective
Masking: Interventional
Masking Description:Participants and observers are blinded to the block position of the superficial cervical plexus
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Conventional landmark technique
inject at the midpoint of the posterior border of the sternocleidomastoid muscle
Procedure: Precise block technique
inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle

Study Arms

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
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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

180

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

August 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Xin Jiang, MD，Shanghai Changzheng Hospital

Study Sponsor ^ICMJE

Xin Jiang, MD

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Shanghai Changzheng Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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