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The study of the minimum effective concentration of ropivacaine for ultrasound-guided costoclavicular brachial plexus block
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注册号:

Registration number:

ChiCTR2200057380 

最近更新日期:

Date of Last Refreshed on:

2022-03-10 

注册时间:

Date of Registration:

2022-03-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

罗哌卡因用于超声引导下肋锁间隙臂丛神经阻滞的最低有效浓度的研究 

Public title:

The study of the minimum effective concentration of ropivacaine for ultrasound-guided costoclavicular brachial plexus block 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

偏性掷币设计研究罗哌卡因用于超声引导下肋锁间隙臂丛神经阻滞的最低有效浓度 

Scientific title:

Biased-coin design to find the minimum effective concentration of ropivacaine for ultrasound-guided costoclavicular brachial plexus block 

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:

朱小强 

研究负责人:

胡兵伟 

Applicant:

Xiao-Qiang Zhu 

Study leader:

Bing-Wei Hu 

申请注册联系人电话:

Applicant telephone:

+8618057134176 

研究负责人电话:

Study leader's telephone:

+8613456976077 

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:

xiaoqiang131314@163.com 

研究负责人电子邮件:

Study leader's E-mail:

whoboy555@hotmail.com 

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:

中国浙江省杭州市西湖区古翠路234号 

研究负责人通讯地址:

中国浙江省杭州市西湖区古翠路234号 

Applicant address:

234 Gucui Road,Xihu District,Hangzhou,Zhejiang,China 

Study leader's address:

234 Gucui Road,Xihu District,Hangzhou,Zhejiang,China 

申请注册联系人邮政编码:

Applicant postcode:

310012 

研究负责人邮政编码:

Study leader's postcode:

310012 

申请人所在单位:

浙江省立同德医院 

Applicant's institution:

Tongde Hospital of Zhejiang Province 

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:

浙同德伦审2022 研第027号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

浙江省立同德医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongde Hospital of Zhejiang Province 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-02-11 

伦理委员会联系人:

王杨 

Contact Name of the ethic committee:

Yang Wang 

伦理委员会联系地址:

中国浙江省杭州市西湖区中竹大厦11楼1号会议室 

Contact Address of the ethic committee:

Meeting Room 1,11th Floor,Zhongzhu Building,Xihu District,Hangzhou,Zhejiang,China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0571-89975971 

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:

胡兵伟 

Primary sponsor:

Bing-Wei Hu 

研究实施负责(组长)单位地址:

中国浙江省杭州市西湖区古翠路234号 

Primary sponsor's address:

234 Gucui Road,Xihu District,Hangzhou,Zhejiang,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):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省立同德医院

具体地址:

中国浙江省杭州市西湖区古翠路234号

Institution
hospital:

Tongde Hospital of Zhejiang Province

Address:

234 Gucui Road,Xihu District,Hangzhou,Zhejiang,China

经费或物资来源:

N/A 

Source(s) of funding:

N/A 

研究疾病:

上肢疾病 

Target disease:

Upper limb disease 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过偏性掷币设计的上下序贯法寻找超声引导下肋锁间隙臂丛神经阻滞罗哌卡因的最低有效浓度,指导临床麻醉用药。 

Objectives of Study:

Our study will find the minimum effective concentration of ropivacaine for ultrasound-guided costoclavicular brachial plexus block by biased-coin design. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

偏倚化抛硬币设计 

Study design:

Biased Coin Design 

纳入标准:

1)ASA分级Ⅰ-Ⅲ级 2)年龄18-80岁 3)上肢疾病手术 4)自愿自主签订知情同意书 

Inclusion criteria

1.ASA physical status Ⅰ-Ⅲ 2.aged between 18-80years 3.Upper limb disease surgery 4.sign informed consent voluntarily and independently 

排除标准:

1)拒绝参加研究 2)局麻药过敏 3)神经阻滞麻醉禁忌 4)智力障碍或无法沟通 5)合并严重的系统性疾病 6)锁骨下窝手术史或穿刺部位感染 7)凝血功能障碍 8)解剖结构畸形 

Exclusion criteria:

1)refusal invitation as a volunteer 2)or have hypersensitivity reaction of local anesthetic 3)or have contraindications of costoclavicular brachial plexus block anesthesia 4)or have intellectual disability or inability to communicate 5)with severe systemic disease 6)with subclavian fossa surgery before or with puncture infection 7)coagulation disorders 8)the anatomical deformity of the subclavian fossa 

研究实施时间:

Study execute time:

From2022-03-01To 2023-02-28 

征募观察对象时间:

Recruiting time:

From2022-03-01To 2023-02-28 

干预措施:

Interventions:

组别:

干预组

样本量:

48

Group:

intervention groups

Sample size:

干预措施:

偏性掷币随机分配不同浓度

干预措施代码:

Intervention:

Defferent doses groups

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):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江省立同德医院 

单位级别:

三甲医院 

Institution
hospital:

Tongde Hospital of Zhejiang Province  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

有效率

指标类型:

主要指标 

Outcome:

Response Rate

Type:

Primary indicator 

测量时间点:

术前

测量方法:

视觉模拟疼痛评分法

Measure time point of outcome:

preoperative

Measure method:

VAS

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

第一位患者使用预设浓度的罗哌卡因,接下来的每一位患者神经阻滞的局麻药浓度都取决于前一位患者的阻滞效果。对于效应靶浓度r,如果前一位患者效果为“失败”(阴性反应),则该患者所用局麻药浓度增加一个单位;如果前一位患者效果为“成功”(阳性反应),则该患者所用局麻药浓度进行偏性掷币随机(靶浓度=r),有b=r/(1-r)的概率减小一个单位,有1-b=0.89的概率保持不变,偏性掷币随机由项目负责人使用R统计软件生产。

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

The first patient recruited received a concentration of ropivacaine,based on our past experience.Subsequently,primary sponsor uses R to randmize the next subject with biased-coin randomization.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

数据将上传到临床试验公共管理平台(ResMan,http://www.medresman.org.cn/),我们将在课题完成后6个月内公开数据。

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

We will share IPD in Clinical Trial Management Public Platform(ResMan,http://www.medresman.org.cn/),and open our data within 6 months after completing this reseach.

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:

课题组成员内的住院医师将完成数据采集,并将CRF汇总给项目负责人,由项目负责人将数据上传到ResMan。

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

A resident physician of our team will complete data collection and give the CRFs to primary sponsor who will share data to ResMan.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-03-10
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