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The effect of modified parasternal block on the perioperative period of off-pump coronary artery bypass patients
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注册号:

Registration number:

ChiCTR2100053403 

最近更新日期:

Date of Last Refreshed on:

2022-05-17 

注册时间:

Date of Registration:

2021-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

改良胸骨旁阻滞对非体外循环冠脉搭桥术患者围术期的影响 

Public title:

The effect of modified parasternal block on the perioperative period of off-pump coronary artery bypass patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改良胸骨旁阻滞对非体外循环冠脉搭桥术患者围术期的影响 

Scientific title:

The effect of modified parasternal block on the perioperative period of off-pump coronary artery bypass patients 

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:

李旭泽 

研究负责人:

李旭泽 

Applicant:

Li Xuze 

Study leader:

Li Xuze 

申请注册联系人电话:

Applicant telephone:

+86 13111531186 

研究负责人电话:

Study leader's telephone:

+86 13111531186 

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:

doclixuze@163.com 

研究负责人电子邮件:

Study leader's E-mail:

doclixuze@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:

河北省石家庄市新华区和平西路215号 

研究负责人通讯地址:

河北省石家庄市新华区和平西路215号 

Applicant address:

215 Heping West Road, Xinhua District, Shijiazhuang, Hebei  

Study leader's address:

215 Heping West Road, Xinhua District, Shijiazhuang, Hebei  

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:

河北医科大学第二医院 

Applicant's institution:

The Second Hospital of Hebei 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:

2021-R462-X01 

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:

河北医科大学第二医院科研伦理委员会 

Name of the ethic committee:

Ethics Committee of the Second Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

崔炜 

Contact Name of the ethic committee:

Cui Wei 

伦理委员会联系地址:

河北省石家庄市新华区和平西路215号 

Contact Address of the ethic committee:

215 Heping West Road, Xinhua District, Shijiazhuang, Hebei  

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:

河北医科大学第二医院 

Primary sponsor:

The Second Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市新华区和平西路215号 

Primary sponsor's address:

215 Heping West Road, Xinhua District, Shijiazhuang, Hebei  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北

市(区县):

石家庄

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第二医院

具体地址:

新华区和平西路215号

Institution
hospital:

The Second Hospital of Hebei Medical University

Address:

215 Heping West Road, Xinhua District

经费或物资来源:

河北省政府资助临床医学优秀人才培养项目 

Source(s) of funding:

The fund of the outstanding clinical training project in Hebei Province government 

研究疾病:

冠心病 

Target disease:

Coronary disease 

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:

I期临床试验 

Study phase:

研究目的:

采用改良胸骨旁神经阻滞复合全身麻醉,研究这种麻醉方法对非体外循环冠脉搭桥手术患者围术期镇痛和术后康复的影响。 

Objectives of Study:

To investigate the effect of modified paracnal nerve block combined general anesthesia on perioperative analgesia and postoperative recovery in patients undergoing off-pump coronary artery bypass surgery. 

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:

择期手术,性别不限,年龄大于35岁,ASA III或IV级。  

Inclusion criteria

Elective surgery, regardless of gender, age >35 years, ASA class III or IV. 

排除标准:

1.严重肝肾功能障碍,胸部畸形或局部感染不能实施MTTPB; 2.有慢性疼痛病史,酗酒,长期使用阿片类药物史,对局麻药物过敏; 3.外周神经病变、认知功能障碍、语言障碍。 

Exclusion criteria:

1. Severe liver and kidney dysfunction, chest deformity or local infection cannot implement MTTPB; 2. History of chronic pain, alcoholism, long-term use of opioids, allergic to local anesthetics; 3. Peripheral neuropathy, cognitive dysfunction, language disorder. 

研究实施时间:

Study execute time:

From2021-12-01To 2022-12-01 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2021-12-01 

干预措施:

Interventions:

组别:

C组

样本量:

29

Group:

group C

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

PSB组

样本量:

29

Group:

group PSB

Sample size:

干预措施:

超声引导下改良胸骨旁神经阻滞

干预措施代码:

Intervention:

Modified the parasternal nerve block with ultrasound guidance

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

石家庄 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Hospital of Hebei Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

阿片类药物用量

指标类型:

主要指标 

Outcome:

Opioid dosage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标 

Outcome:

pain score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部并发症

指标类型:

次要指标 

Outcome:

Pulmonary complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性疼痛发生率

指标类型:

次要指标 

Outcome:

Incidence of chronic pain

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后机械通气时间

指标类型:

次要指标 

Outcome:

Postoperative mechanical ventilation time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU停留时间

指标类型:

次要指标 

Outcome:

Length of stay in ICU

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of stay in hospital

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后恶心呕吐

指标类型:

次要指标 

Outcome:

Postoperative nausea and vomiting

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排气时间

指标类型:

次要指标 

Outcome:

First exhaust time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便时间

指标类型:

次要指标 

Outcome:

First defecation time

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:

标本中文名:

血液

组织:

Sample Name:

blood

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 35 years
最大 Max age 100 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):

电脑生成随机数字序列

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

Random number sequence generated by computer

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):

excel

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

excel

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:

CRF

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

CRF

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:

 2021-11-20
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