今天是:2022-05-24 星期二

度洛西汀对全髋关节置换术后疼痛、功能康复的疗效研究
下载XML文档

注册号:

Registration number:

ChiCTR2000033606 

最近更新日期:

Date of Last Refreshed on:

2020-12-21 

注册时间:

Date of Registration:

2020-06-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

度洛西汀对全髋关节置换术后疼痛、功能康复的疗效研究 

Public title:

The effect of duloxetine on pain and functional rehabilitation after total hip replacement: a randomized controlled trial. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

度洛西汀对全髋关节置换术后疼痛、功能康复的疗效研究:一项随机对照研究 

Scientific title:

The Effects of Duloxetine on Pain and Hip Function After Total Hip Arthroplasty: a Randomized Controlled Trial 

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:

丁子川 

研究负责人:

周宗科 

Applicant:

Zichuan Ding 

Study leader:

Zongke Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13258217002 

研究负责人电话:

Study leader's telephone:

+86 18980601028 

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:

zichuanding@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhouzongke@scu.edu.cn 

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:

成都市武侯区国学巷37号 

研究负责人通讯地址:

成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan 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:

2020-843 

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:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

Clinical Research and Biomedical Ethical Committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-04 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

Zejin Zuo 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院老八教四楼412室 

Contact Address of the ethic committee:

Room 412, Old Teaching Building 8, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

卫生部行业科研专项基金 

Source(s) of funding:

Ministry of Health Special Scientific Research Projects of China  

研究疾病:

全髋关节置换术 

Target disease:

Total hip arthroplasty 

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:

上市后药物 

Study phase:

研究目的:

研究度洛西汀对全髋关节置换术后疼痛、功能康复的疗效。 

Objectives of Study:

To investigate The Effects of Duloxetine on Pain and Hip Function after Total Hip Arthroplasty. 

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:

拟行全髋关节置换术, 年龄18-85岁, 签署知情同意书。 

Inclusion criteria

1. Patients to be treated with total hip replacement; 2. Patients aged 18-85 years; 3. Patients who sign informed consent. 

排除标准:

术前诊断焦虑抑郁(汉密尔顿抑郁量表评分超过20); 度洛西汀过敏; 既往度洛西汀服用史; 术前炎性因子高(CRP>20mg/L); 术前血小板功能异常或凝血功能异常; 肝肾功能异常。 

Exclusion criteria:

1. Preoperative diagnosis of anxiety and depression patients (Hamilton Depression Scale score more than 20); 2. Patients with duloxetine allergy; 3. Patients who have taken duloxetine before; 4. Patients with high preoperative inflammatory factor (CRP > 20mg / L); 5. Patients with abnormal platelet function or coagulation function before operation; 6. Patients with abnormal liver and kidney function. 

研究实施时间:

Study execute time:

From2020-06-08To 2020-09-07 

征募观察对象时间:

Recruiting time:

From2020-06-08To 2020-07-31 

干预措施:

Interventions:

组别:

Group A

样本量:

50

Group:

Group A

Sample size:

干预措施:

度洛西汀

干预措施代码:

Intervention:

Duloxetine

Intervention code:

组别:

Group B

样本量:

50

Group:

Group B

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疼痛VAS评分

指标类型:

主要指标 

Outcome:

VAS pain 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:

术后阿片类药物使用量

指标类型:

主要指标 

Outcome:

Postoperative morphine consumption

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TUG试验

指标类型:

次要指标 

Outcome:

Timed Up & Go Test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节活动度

指标类型:

次要指标 

Outcome:

Range of motion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Harris髋关节评分

指标类型:

次要指标 

Outcome:

Harris Hip 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:

Womac评分

指标类型:

次要指标 

Outcome:

Womac 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:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

SF-12

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

指标类型:

次要指标 

Outcome:

Complication

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 85 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):

与手术及评价无关的科研人员使用Excel软件产生的随机方法。

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

Researchers who do not related to surgery or evaluation utilize Excel software in computer to generate random method.

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):

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):

网络平台

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

Internet database

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

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

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-06
返回列表