今天是:2018-10-24 星期三

超声引导竖脊肌平面阻滞背部感觉阻滞范围及消退时间观察
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注册号:

Registration number:

ChiCTR1800014438 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

超声引导竖脊肌平面阻滞背部感觉阻滞范围及消退时间观察 

Public title:

Observation of the range of sensory block and extinction time of the erector spinae plane block guided by ultrasound  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导竖脊肌平面阻滞背部感觉阻滞范围及消退时间观察 

Scientific title:

Observation of the range of sensory block and extinction time of the erector spinae plane block guided by ultrasound  

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

张竞雄 

研究负责人:

徐旭仲 

Applicant:

Jingxiong Zhang 

Study leader:

Xuzhong Xu 

申请注册联系人电话:

Applicant telephone:

+86 18267710879 

研究负责人电话:

Study leader's telephone:

+86 13706657700 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

214621943@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xuzhong@263.net 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

浙江省温州市瓯海区梧田街道博沃嘉园1-704 

研究负责人通讯地址:

浙江省温州市瓯海区南白象街道上蔡村 

Applicant address:

1-704 Community Bowojiayuan, Wutian Street, Ouhai District, Wenzhou, China 

Study leader's address:

Shangcai Villiage, Nanbaixiang Street, Ouhai District, Wenzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

温州医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Wenzhou Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017-223 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

温州医科大学附属第一医院伦理委员会 

Name of the ethic committee:

The Independent Ethics Committee at the First Affiliated Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-11 

伦理委员会联系人:

金嵘 

Contact Name of the ethic committee:

Rong Jin 

伦理委员会联系地址:

浙江省温州市瓯海区南白象街道上蔡村 

Contact Address of the ethic committee:

Shangcai Villiage,Nanbaixiang Street,Ouhai District,Wenzhou,China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

温州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市瓯海区南白象街道上蔡村 

Primary sponsor's address:

Shangcai Villiage,Nanbaixiang Street,Ouhai District,Wenzhou,China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第一医院

具体地址:

浙江省温州市瓯海区南白象街道上蔡村

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University

Address:

Shangcai Villiage,Nanbaixiang Street,Ouhai District,Wenzhou,China

经费或物资来源:

温州医科大学附属第一医院 

Source(s) of funding:

The First Affiliated Hospital of Wenzhou Medical University 

研究疾病:

竖脊肌平面阻滞 

Target disease:

erector spinae plane block 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

描述超声引导胸5横突水平竖脊肌平面阻滞后背部阻滞特征:背部皮肤感觉缺失范围和阻滞持续时间 

Objectives of Study:

We aims to detect the cutaneous sensory block area and recession of blocked dermatomes after erector spaine block at the level of transverse process of fifth thoracic vertebrae under ultrasound-guidance  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

年龄大于18周岁,背部皮肤感觉完整 

Inclusion criteria

Aged older than eighteen years,dorsal skin intact sensation. 

排除标准:

局麻药或该研究中其他药物过敏史,语言沟通及理解障碍,ASA3级以上,体重指数小于18或大于30kg/m2,脊柱畸形,神经性病变,脊髓功能异常。 

Exclusion criteria:

With history of allergy to ropivacaine or other drugs used in this trial, communication obstacle in language, ASA classification ≥3, body mass index≤ 18 or ≥30kg/m2,spinal demormities, neuropathy, spinal cord disorders  

研究实施时间:

Study execute time:

From2018-01-15To 2018-04-01 

干预措施:

Interventions:

组别:

Case series

样本量:

12

Group:

Case series

Sample size:

干预措施:

超声引导胸5水平竖脊肌平面阻滞

干预措施代码:

Intervention:

cutaneous sensory block area and recession of blocked dermatomes after erector spaine block anaesthesia at the level of transverse process of fifth thoracic vertebrae under ultrasound-guidance

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhengjiang 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

背部皮肤感觉阻滞分布特征

指标类型:

主要指标 

Outcome:

distribution characteristic of dorsal cutaneous sensory block area

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左背部皮肤感觉阻滞面积

指标类型:

主要指标 

Outcome:

cutaneous sensory block area of left dorsal wall

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左背部皮肤感觉阻滞比例

指标类型:

主要指标 

Outcome:

percent area of left dorsum blocked

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阻滞节段消退情况

指标类型:

主要指标 

Outcome:

regression of blocked demattomes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局麻药中毒

指标类型:

主要指标 

Outcome:

local anesthetic intoxication

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心

指标类型:

次要指标 

Outcome:

nausea

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呕吐

指标类型:

次要指标 

Outcome:

vomit

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肿

指标类型:

次要指标 

Outcome:

haematoma

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

not applicable

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

原始数据将于试验结束后上传至本网站对公众公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data will be uploaded to this website and accessible to public after trial

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

温州医科大学附属第一医院

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The First Affiliated Hospital of Wenzhou Medical University

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-13
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