今天是:2019-06-18 星期二

胸椎旁阻滞用于老年患者肱骨近端内固定术中的镇痛增效比较
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注册号:

Registration number:

ChiCTR1900021955 

最近更新日期:

Date of Last Refreshed on:

2019-04-14 

注册时间:

Date of Registration:

2019-04-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胸椎旁阻滞用于老年患者肱骨近端内固定术中的镇痛增效比较 

Public title:

Efficacy of paravertebral block in improving analgesia in elderly patients undergoing proximal humerus fracture fixation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胸椎旁阻滞用于老年患者肱骨近端内固定术中的镇痛增效比较 

Scientific title:

Efficacy of paravertebral block in improving analgesia in elderly patients undergoing proximal humerus fracture fixation 

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:

王晓峰 

研究负责人:

王晓峰 

Applicant:

Xiaofeng Wang 

Study leader:

Xiaofeng Wang 

申请注册联系人电话:

Applicant telephone:

+86 18930170135 

研究负责人电话:

Study leader's telephone:

+86 18930170135 

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:

240483680@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

240483680@qq.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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200233 

研究负责人邮政编码:

Study leader's postcode:

200233 

申请人所在单位:

上海交通大学附属第六人民医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital 

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:

2019-030 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-28 

伦理委员会联系人:

孙秀秀 

Contact Name of the ethic committee:

Xiuxiu Sun 

伦理委员会联系地址:

上海市宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 64369181-58654 

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:

上海交通大学附属第六人民医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号第六人民医院 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属第六人民医院

具体地址:

徐汇区宜山路600号

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Address:

600 Yishan Road, Xuhui District

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

肱骨近端骨折 

Target disease:

proximal humerus fracture 

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:

探索性研究/预试验 

Study phase:

研究目的:

在肌间沟臂丛+浅颈丛阻滞的基础上,观察联合T2胸椎旁阻滞在老年肱骨近端骨折手术中的镇痛增强效果。 

Objectives of Study:

To observe the effcacy of paravertevral block combined with interscalne brancial plexus and cervical pelxus block in improving analgesia in elderly patients undergoing proximal humerus fracture fixation. 

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:

1) 同意加入本研究并获取知情同意书; 2) 年龄65岁(含)以上; 3) BMI(体重指数)<30; 4) 美国麻醉医师协会(ASA)分级I~II级; 5) 单侧肱骨近端骨折,拟行切开复位内固定术。 

Inclusion criteria

1) Agree to join the study and obtain informed consent; 2) Aged 65 years or older; 3) BMI < 30 4) American Society of Anesthesiologists (ASA) Classification I-II; 5) Open reduction and internal fixation for unilateral proximal humeral fracture. 

排除标准:

1) 各种原因导致无法进行T2胸椎旁阻滞; 2) 凝血功能障碍或接受抗凝治疗者; 3) 有上肢神经损伤或膈神经损伤病史者; 4) 复合伤; 5) 术前合并未控制的呼吸系统疾病,如低氧血症、COPD、哮喘、肺部感染、气胸、既往肺部手术史,术前测得吸氧的情况下(3ml/min),指脉氧SPO2<95%; 6) 术前合并未控制的高血压病,入室收缩压>180mmHg或舒张压>110mmHg; 7) 术前合并未控制的冠心病、心脏瓣膜病、心律失常; 8) 任何导致神经阻滞无法实施的情况(如穿刺部位局部感染、肿胀,无法改变体位等); 9) 无法正常交流或配合麻醉(语言交流障碍、智力低下、阿尔茨海默、帕金森等); 10) 对罗哌卡因过敏或其他神经阻滞禁忌症。 

Exclusion criteria:

1) T2 paravertebral block can not be performed for various reasons; 2) Patients with coagulation dysfunction or receiving anticoagulation therapy; 3) Persons with a history of upper limb nerve injury or phrenic nerve injury; 4) Compound injury; 5) Preoperative Pulse Oxygen Saturation(SPO2)<95% due to uncontrolled respiratory diseases such as hypoxemia, COPD, asthma, pulmonary infection, pneumothorax, previous pulmonary surgery history when oxygen is given at the flow of 3L/min; 6) Preoperative uncontrolled hypertension(systolic blood pressure>180 mmHg or diastolic blood pressure>110 mmHg) 7) Uncontrolled coronary heart disease, valvular heart disease and arrhythmia before operation; 8) Any reason that causes nerve block impossible to be performed (e.g. local infection at puncture site, swelling, unable to change position, etc.); 9) Fail to communicate or cooperate (mental retardation, Alzheimer, Parkinson, etc.); 10) Be allergic to ropivacaine or has other contraindications for nerve block. 

研究实施时间:

Study execute time:

From2019-04-16To 2020-05-01 

干预措施:

Interventions:

组别:

ICTP组

样本量:

40

Group:

ICTP

Sample size:

干预措施:

肌间沟+浅颈丛+T2胸椎旁阻滞

干预措施代码:

Intervention:

IC+T2 PVB

Intervention code:

组别:

IC组

样本量:

40

Group:

IC

Sample size:

干预措施:

肌间沟+浅颈丛阻滞

干预措施代码:

Intervention:

interscalene brachial plexus and cervial plexus block

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属第六人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

阻滞成功率

指标类型:

主要指标 

Outcome:

success rate

Type:

Primary indicator 

测量时间点:

手术中

测量方法:

患者主观判断

Measure time point of outcome:

Measure method:

指标中文名:

感觉阻滞情况

指标类型:

次要指标 

Outcome:

sensory block

Type:

Secondary indicator 

测量时间点:

神经阻滞完成后20Mins

测量方法:

针刺

Measure time point of outcome:

Measure method:

指标中文名:

辅助瑞芬后能完成手术的比例

指标类型:

次要指标 

Outcome:

Proportion of patients who can complete surgery with remifentanil

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

需要中转喉罩全麻的比例

指标类型:

次要指标 

Outcome:

proportion of general anesthesia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管活性药物用量

指标类型:

次要指标 

Outcome:

Dosage of vasoactive drugs

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12小时疼痛NRS评分

指标类型:

次要指标 

Outcome:

NRS at 12H postoperation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中不良事件率

指标类型:

副作用指标 

Outcome:

adverse reation rate

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后神经阻滞相关并发症

指标类型:

副作用指标 

Outcome:

Complications associated with nerve block

Type:

Adverse events 

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 65 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):

利用计算机软件产生随机分配序列,产生80个随机整数(1-80),1-40号分配入IC组,41-80号分配入ICTP组。

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

Using computer software to generate random allocation sequence by a non-participant researcher.

盲法:

open

Blinding:

open

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):

电子邮件联系项目负责人

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

E-mail contact project leader

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:

使用excel表格和SPSS软件保存和管理数据

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

The data will be reposited and managed by excel and SPSS

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-14
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