今天是:2020-04-08 星期三

超声引导下神经阻滞对全膝关节置换术患者早期康复的影响
下载XML文档

注册号:

Registration number:

ChiCTR2000031258 

最近更新日期:

Date of Last Refreshed on:

2020-03-27 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

超声引导下神经阻滞对全膝关节置换术患者早期康复的影响 

Public title:

Effect of ultrasound-guided nerve block on early rehabilitation of patients undergoing total knee arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导下神经阻滞对全膝关节置换术患者早期康复的影响 

Scientific title:

Effect of ultrasound-guided nerve block on early rehabilitation of patients undergoing total knee arthroplasty 

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:

王野 

研究负责人:

郭正纲 

Applicant:

Ye Wang 

Study leader:

Zhenggang Guo 

申请注册联系人电话:

Applicant telephone:

+86 13581824010 

研究负责人电话:

Study leader's telephone:

+86 13581918132 

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:

wangye198169@163.com 

研究负责人电子邮件:

Study leader's E-mail:

GSgzg304@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:

北京市石景山区晋元庄路9号 

研究负责人通讯地址:

北京市石景山区晋元庄路9号 

Applicant address:

9 Jinyuanzhuang Road, Shijingshan District, Beijing, China 

Study leader's address:

9 Jinyuanzhuang Road, Shijingshan 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:

北京大学首钢医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Peking University Shougang 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:

SGYYQ201913 

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:

北京大学首钢医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shougang Hospital, Peking University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-29 

伦理委员会联系人:

袁平 

Contact Name of the ethic committee:

Ping Yuan 

伦理委员会联系地址:

北京石景山区晋元庄路9号 

Contact Address of the ethic committee:

9 Jinyuanzhuang Road, Shijingshan 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:

北京大学首钢医院 

Primary sponsor:

Peking University Shougang Hospital  

研究实施负责(组长)单位地址:

北京市石景山区晋元庄路9号 

Primary sponsor's address:

9 Jinyuanzhuang Road, Shijingshan 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):

石景山区

Country:

China

Province:

Beijing

City:

Shijingshan District

单位(医院):

北京大学首钢医院

具体地址:

晋元庄路9号

Institution
hospital:

Peking University Shougang Hospital

Address:

9 Jinyuanzhuang Road

经费或物资来源:

院内青年基金课题 

Source(s) of funding:

Youth Fund in the hospital 

研究疾病:

膝关节病变 

Target disease:

Knee joint 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:

其它 

Study phase:

N/A 

研究目的:

本研究将在全膝关节置换手术后应用不同的神经阻滞方式以及不同的药物配比来观察患者术后镇痛及早期康复的情况。 

Objectives of Study:

This study will use different nerve block methods and different drug ratio to observe the postoperative analgesia and early rehabilitation of patients after total knee replacement. 

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:

患者知情同意且获得医院伦理委员会批准; 行择期全膝关节置换术; 年龄18-79岁; ASA分级Ⅰ~Ⅲ级; BMI18-35kg/㎡。 

Inclusion criteria

The patients had informed consent and obtained the approval of the hospital ethics committee; they underwent selective total knee arthroplasty; the age was 18-79 years old; ASA grade I-III; BMI 18-35kg / ㎡. 

排除标准:

膝关节外伤、手术、恶性肿瘤病史,下肢神经或肌肉原发疾病; 严重基础疾病,如心、肝、肺、肾、脑等脏器功能障碍及凝血功能异常; 精神疾病史; 存在认知障碍,不能完成疼痛数字分级法 (VAS) 镇痛评分; 椎管内麻醉禁忌者; 对本研究所使用药物中的任意一种过敏者。 

Exclusion criteria:

Patients who has a history of knee joint trauma, surgery, malignant tumor, primary diseases of lower limb nerve or muscle; serious basic diseases, such as heart, liver, lung, kidney, brain and other organ dysfunction and coagulation function abnormality; history of mental disease; cognitive impairment, unable to complete pain numerical classification (VAS) analgesia score; contraindications of intraspinal anesthesia. Allergic to any one of the drugs used in this study. 

研究实施时间:

Study execute time:

From2020-05-01To 2021-08-30 

干预措施:

Interventions:

组别:

股神经阻滞F1组

样本量:

45

Group:

Femoral nerve block group F1

Sample size:

干预措施:

股神经阻滞,罗哌卡因术后镇痛

干预措施代码:

Intervention:

Femoral nerve block and postoperative analgesia with ropivacaine

Intervention code:

组别:

股神经阻滞F2组

样本量:

45

Group:

Femoral nerve block group F2

Sample size:

干预措施:

股神经阻滞,罗哌卡因和右美托咪定镇痛

干预措施代码:

Intervention:

Femoral nerve block, ropivacaine and dexmedetomidine analgesia

Intervention code:

组别:

收肌管阻滞A1组

样本量:

45

Group:

Adductor block group A1

Sample size:

干预措施:

收肌管阻滞,罗哌卡因镇痛

干预措施代码:

Intervention:

Adductor block, ropivacaine analgesia

Intervention code:

组别:

收肌管阻滞A2组

样本量:

45

Group:

Adductor block group A2

Sample size:

干预措施:

收肌管阻滞,罗哌卡因和右美托咪定镇痛

干预措施代码:

Intervention:

Adductor block, ropivacaine and dexmedetomidine analgesia

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 

市(区县):

石景山区 

Country:

China 

Province:

Beijing 

City:

Shijingshan District 

单位(医院):

北京大学首钢医院 

单位级别:

三级 

Institution
hospital:

Peking University Shougang Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

静息状态VAS评分

指标类型:

主要指标 

Outcome:

Rest state 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:

被动活动VAS评分

指标类型:

主要指标 

Outcome:

VAS score of passive activity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

股四头肌肌力

指标类型:

次要指标 

Outcome:

Quadriceps femoris muscle strength

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节屈曲度

指标类型:

次要指标 

Outcome:

Knee flexion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

跌倒风险评估

指标类型:

次要指标 

Outcome:

Fall risk assessment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次下地行走时间

指标类型:

次要指标 

Outcome:

First walk 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:

术后72小时行走距离

指标类型:

次要指标 

Outcome:

72 hours walking distance after operation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇痛泵追加次数

指标类型:

次要指标 

Outcome:

Additional times of analgesia pump

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein,CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-6

指标类型:

次要指标 

Outcome:

interleukin-6, IL-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原

指标类型:

次要指标 

Outcome:

procalcitonin, PCT

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:

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:

术后进食水时间

指标类型:

次要指标 

Outcome:

Postoperative water intake 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:

镇静评分

指标类型:

次要指标 

Outcome:

Sedation 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:

患者满意度评分

指标类型:

次要指标 

Outcome:

Patient satisfaction 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:

并发症情况

指标类型:

次要指标 

Outcome:

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:

年龄

指标类型:

次要指标 

Outcome:

age

Type:

Secondary 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:

次要指标 

Outcome:

gender

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ASA分级

指标类型:

次要指标 

Outcome:

ASA grading

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

次要指标 

Outcome:

BMI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前诊断

指标类型:

次要指标 

Outcome:

Preoperative diagnosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前合并症

指标类型:

次要指标 

Outcome:

Preoperative 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:

手术时间

指标类型:

次要指标 

Outcome:

Operative 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:

麻醉时间

指标类型:

次要指标 

Outcome:

Anesthesia 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:

术后镇痛药物使用情况

指标类型:

次要指标 

Outcome:

Use of analgesics after operation

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 79 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):

随机数字表法

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

randomized number table

盲法:

未说明

Blinding:

Not stated

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:

即时公开/Real time access

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):

ResMan临床试验公共管理平台, http://www.medresman.org.cn.

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

ResMan, http://www.medresman.org.cn.

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:

采用SPSS软件进行统计学分析,使用Excel表格进行试验记录

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

Excel and IBM SPSS Statistics software

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-26
返回列表