Ultrasound-guided Precise Superficial Cervical Plexus Block

赞助:

合作者:

信息的提供 (责任方):

Xin Jiang, MD，Shanghai Changzheng Hospital

追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

August 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^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.

描述性信息

简略标题 ^ICMJE

Ultrasound-guided Precise Superficial Cervical Plexus Block

正式标题 ^ICMJE

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

简要概况

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

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Randomize, double blind, prospective
盲法: Interventional
盲法描述:Participants and observers are blinded to the block position of the superficial cervical plexus
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^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

研究工具

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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

180

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2019

预计主要完成日期

August 2019 (主要结果测量的最终数据收集日期)

合格标准 ^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

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：80 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Xin Jiang, MD，Shanghai Changzheng Hospital

研究赞助商 ^ICMJE

Xin Jiang, MD

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Shanghai Changzheng Hospital

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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