Ultrasound-guided Precise Superficial Cervical Plexus Block

NCT03695211 | Unknown

• 1 other identifier: CHANGZHENG2018-19
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Superficial Cervical Plexus Block

Keywords

great auricular nerve; sternocleidomastoid muscle; ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of onset time of success block in each group

  up to 15minutes

• Comparison of pain score after surgery at PACU in each group

  Day of surgery, Arrival time of PACU

Study Arms (2)

LM group

ACTIVE COMPARATOR

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

GAN Group

EXPERIMENTAL

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

Interventions

Conventional landmark technique PROCEDURE

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

LM group

Precise block technique PROCEDURE

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

GAN Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xin Jiang, MD: lead

Study Sites (1)

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Study Officials

• Xin Jiang, M.D

  Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbin Yuan, M.D

CONTACT

86-21-81885821; jfjczyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and observers are blinded to the block position of the superficial cervical plexus
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomize, double blind, prospective

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: May 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-04

Locations

CN (1)