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临床试验/NCT03695211
NCT03695211Unknown不适用

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

Xin Jiang, MD1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1
主要终点
Comparison of block success rate in each group

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and observers are blinded to the block position of the superficial cervical plexus

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Comparison of block success rate in each group

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Xin Jiang, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin Jiang, MD

Principal Investigator

Shanghai Changzheng Hospital

研究点 (1)

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