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耳大神经阻滞在鼓室乳突手术围术期临床应用
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注册号:

Registration number:

ChiCTR1800014333 

最近更新日期:

Date of Last Refreshed on:

2018-01-06 

注册时间:

Date of Registration:

2018-01-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

耳大神经阻滞在鼓室乳突手术围术期临床应用 

Public title:

Perioperative pracitice of ultrasound-guided great auricular nerve block in tympanomastoid surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

耳大神经阻滞在鼓室乳突手术围术期临床应用 

Scientific title:

Perioperative pracitice of ultrasound-guided great auricular nerve block in tympanomastoid surgery 

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:

刘金升 

研究负责人:

刘金升 

Applicant:

Liu Jinsheng 

Study leader:

Liu Jinsheng 

申请注册联系人电话:

Applicant telephone:

+86 13717942969 

研究负责人电话:

Study leader's telephone:

+86 13717942969 

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:

jinshengliu777@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jinshengliu777@163.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:

北京市东城区东交民巷1号北京同仁医院麻醉科 

研究负责人通讯地址:

北京市东城区东交民巷1号北京同仁医院麻醉科 

Applicant address:

1 Dongjiao Minxiang, Dongcheng District, Beijing, China 

Study leader's address:

1 Dongjiao Minxiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院 

Applicant's institution:

Beijing Tongren Hospital, Capital 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:

TRECKY2016-015 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tongren Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-06-20 

伦理委员会联系人:

常灏 

Contact Name of the ethic committee:

Chang Hao 

伦理委员会联系地址:

北京东城区东交民巷1号北京同仁医院科技处 

Contact Address of the ethic committee:

Department of science and technology,Bejing Tongren Hospital, 1 Dongjiao Minxiang, Dongcheng District, Beijing, 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:

首都医科大学附属北京同仁医院 

Primary sponsor:

Beijing Tongren Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区东交民巷1号北京同仁医院麻醉科 

Primary sponsor's address:

Department of Anesthesiology, Beijing Tongren Hospital, 1 Dongjiao Minxiang, Dongcheng District, Beijing, 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):

北京

市(区县):

东城区

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区东交民巷1号北京同仁医院

Institution
hospital:

Beijing Tongren Hospital,Capital Medical University

Address:

1 Dongjiao Minxiang, Dongcheng District, Beijing, China

经费或物资来源:

首都医科大学附属北京同仁医院科研骨干培育基金 

Source(s) of funding:

Fund for Fostering Scientific Backbone of Beijing Tongren Hospital Affiliated to Capital Medical University 

研究疾病:

鼓室乳突手术的麻醉方法 

Target disease:

Anesthesia of tympanomastoid surgery 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

①建立超声引导下耳大神经阻滞技术规范。包括穿刺点的选择,超声探查成像规范,平面内或平面外超声引导下穿刺技术规范,局麻药物的选择,局麻药物的浓度与剂量,穿刺针的选择等。②明确耳大神经阻滞的临床效果,包括对术中麻醉维持的影响,耳大神经阻滞后其术后镇痛持续时间,以及减少术后阿片类药物应用,降低术后恶心呕吐等不良反应的影响。③评价耳大神经阻滞围术期的经济学效应。包括减少术中全麻药用量,促进患者尽早恢复,降低术后阿片类及非甾体类镇痛用药用量,降低术后恶心呕吐发生率及由此产生的医疗费用等多方面减低医疗费用的效应。 

Objectives of Study:

(1) to explore and establish the technical specification of ultrasound-guided great auricular nerve block. It includes selection of puncture points, ultrasound imaging, in-plane or out-plane ultrasound guided techniques, selection of local anesthetic agents, concentration and dose of local anesthetics, and selection of puncture needles; (2) to clarify the clinical effects of great auricular nerve block, including its effect on incision and anesthesia maintaince, the duration of postoperative analgesia, the effect on post-operative pain, the reduction of opioid consumption post-operation, and reduction of the postoperative adverse reactions such as nausea and vomiting; (3) to evaluate the economic effect of great auricular nerve block during the perioperative period. It includes reducing the dosage of general anesthetics, promoting the recovery of patients as early as possible, reducing the dosage of opioid and NSAIDS analgesics, reducing the incidence of postoperative nausea and vomiting, and the resulting reduction of medical costs. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

ASAⅠ~Ⅱ级,年龄18—60岁,拟行乳突鼓室手术的全麻住院病人,无凝血功能障碍,未接受抗凝或抗血小板治疗,无神经系统疾患,无严重心律失常(尤其是II度II型及以上房室传导阻滞,QT间期延长等),无重度高血压、冠心病、脑缺血疾病且已签订《知情同意书》的患者。 

Inclusion criteria

ASA I-II, aged 18-60yr, scheduled for tympanomastoid surgery with postauricular incisions under general anesthesia, without coagulopath, not receiving anticoagulant or antiplatelet therapy, without nerve system diseases, no serious cardiac arrhythmias (especially mobitz II or high degree A-VB, QT prolongation, etc.) without severe hypertension, without coronary heart disease, without cerebrovascular disease, and with approvel of the informed consent. 

排除标准:

凝血功能障碍,外周神经病变,罗哌卡因过敏,高血压,缺血性心脑血管疾病,有临床症状的心电图异常患者。 

Exclusion criteria:

Exclusion criteria were coagulopathies,peripheral neuropathy, known allergy or hypersensitivity to ropivacaine, hypertension, ischemic diseases of brain and heart, and clinically relevant abnormalities in the ECG. 

研究实施时间:

Study execute time:

From2015-06-01To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2018-12-31 

干预措施:

Interventions:

组别:

A

样本量:

30

Group:

A

Sample size:

干预措施:

干预措施代码:

Intervention:

Intervention code:

组别:

B

样本量:

30

Group:

B

Sample size:

干预措施:

0.25%罗哌卡因耳大神经阻滞

干预措施代码:

Intervention:

Great auricular nerve block by0.25% Ropivacaine

Intervention code:

组别:

C

样本量:

30

Group:

C

Sample size:

干预措施:

0.5%罗哌卡因耳大神经阻滞

干预措施代码:

Intervention:

Great auricular nerve block by 0.5% Ropivacaine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tongren Hospital, Capital Medical Uinversity  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

耳大神经阻滞持续时长

指标类型:

主要指标 

Outcome:

Duration fo great auricular nerve block

Type:

Primary indicator 

测量时间点:

术后随访

测量方法:

针刺法测试

Measure time point of outcome:

post operation

Measure method:

pinprick test

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

切皮前后

测量方法:

Measure time point of outcome:

pre- and post- incision

Measure method:

指标中文名:

心率

指标类型:

主要指标 

Outcome:

HR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

异丙酚消耗量

指标类型:

主要指标 

Outcome:

consumption of propofol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瑞芬太尼消耗量

指标类型:

主要指标 

Outcome:

consumption of remifentanil

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛VAS评分

指标类型:

主要指标 

Outcome:

post operation VAS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补救镇痛应用与否

指标类型:

主要指标 

Outcome:

remidial analgesia application or not

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

主要指标 

Outcome:

age

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

主要指标 

Outcome:

gender

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体质量指数:BMI

指标类型:

主要指标 

Outcome:

body mass index: BMI

Type:

Primary 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:

标本中文名:

组织:

Sample Name:

no

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 60 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):

刘金升,随机数字法

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

Liu Jinsheng ,Random number method

盲法:

Blinding:

是否共享原始数据:

IPD sharing

是Yes

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):

http://www.medresman.org/uc/index.aspx

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

http://www.medresman.org/uc/index.aspx

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:

电子采集和管理系统(Electronic Data Capture, EDC)

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

Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-01-06
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