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全膝关节置换术和全髋关节置换术术后关节周围注射给药镇痛效果及非甾体类抗炎药的使用
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注册号:

Registration number:

ChiCTR-INR-17012217 

最近更新日期:

Date of Last Refreshed on:

2017-08-01 

注册时间:

Date of Registration:

2017-08-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

全膝关节置换术和全髋关节置换术术后关节周围注射给药镇痛效果及非甾体类抗炎药的使用 

Public title:

Effects of periarticular injection on analgesic effects and NSAID use in total knee arthroplasty and total hip arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全膝关节置换术和全髋关节置换术术后关节周围注射给药镇痛效果及非甾体类抗炎药的使用 

Scientific title:

Effects of periarticular injection on analgesic effects and NSAID use in total knee arthroplasty and total hip 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:

班文瑞 

研究负责人:

张晨 

Applicant:

Wenrui Ban 

Study leader:

Chen Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15202487386 

研究负责人电话:

Study leader's telephone:

+86 18209277651 

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:

banwenrui@163.com 

研究负责人电子邮件:

Study leader's E-mail:

osteozhang@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:

陕西省西安市雁塔区雁塔西路76号西安交通大学医学院 

研究负责人通讯地址:

陕西省西安市新城区西五路西安交通大学第二附属医院 

Applicant address:

76 Yanta Road West, Yanta District, Xi'an, Shaanxi, China 

Study leader's address:

West Fifth Road, Xincheng District, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710000 

研究负责人邮政编码:

Study leader's postcode:

710000 

申请人所在单位:

西安交通大学第二附属医院 

Applicant's institution:

Second Affiliated Hospital of Xi'an Jiaotong 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:

2012-693 

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:

西安交通大学医学生物科研伦理委员会 

Name of the ethic committee:

Medical and Biological Research Ethics Committee of Xi'an Jiaotong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-07-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

西安交通大学第二附属医院 

Primary sponsor:

Second Affiliated Hospital of Xi'an Jiaotong University 

研究实施负责(组长)单位地址:

陕西省西安市雁塔区雁塔西路76号 

Primary sponsor's address:

76 Yanta Road West, Yanta District, Xi'an, Shaanxi, 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):

陕西

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

西安交通大学第二附属医院

具体地址:

陕西省西安市新城区西五路

Institution
hospital:

Second Affiliated Hospital of Xi'an Jiaotong University

Address:

West Fifth Road, Xincheng District, Xi'an, Shaanxi Province

经费或物资来源:

西安交通大学第二附属医院院基金 

Source(s) of funding:

Xi'an Jiaotong University Second Affiliated Hospital Foundation 

研究疾病:

关节炎 

Target disease:

arthritis 

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:

a) 比较术后3个月内单用非甾体类抗炎药按需治疗组和非甾体类抗炎药按需给药联合多模式镇痛治疗组的人工髋、膝关节置换术后患者其非甾体类抗炎药消耗的数量 b) 评价由酮咯酸氨丁三醇、罗哌卡因、地塞米松、肾上腺素所组合的多模式镇痛药对于人工髋、膝关节置换术后疼痛的控制效果。 c) 根据治疗期间出现的所有不良事件的发生率、严重程度、严重性、相关性及频率评价多模式镇痛药治疗的安全性。 

Objectives of Study:

A) compared with the use of non-steroidal anti-inflammatory drugs on the on-demand treatment group and non-steroidal anti-inflammatory drugs in the three months after surgery combined with multi-mode analgesic treatment group of artificial hip, knee replacement The number of non-steroidal antiinflammatory drugs consumed by the patient B) To evaluate the efficacy of multimodal analgesics combined with ketorolac tartrate, ropivacaine, dexamethasone and adrenaline for pain after artificial hip and knee replacement. C) evaluate the safety of multimodal analgesic treatment based on the incidence, severity, severity, relevance, and frequency of all adverse events that occur during treatment. 

药物成份或治疗方案详述:

将入组的人工髋、膝关节置换术患者于每一治疗亚组(人工髋关节置换术组、人工膝关节置换术组)下随机分为单用非甾体类抗炎药按需治疗组(A组)和非甾体类抗炎药按需给药联合多模式镇痛治疗组(B组)。详细记录患者病史、之前的用药信息、人口统计学资料、体格检查等。两组均于术后给予常规镇痛泵治疗外,A组患者术后仅给予非甾体类抗炎药治疗。B组患者于手术结束缝合时关节周围注射混合镇痛药物。 

Description for medicine or protocol of treatment in detail:

The patients underwent artificial hip and knee arthroplasty were randomly divided into three groups: non-steroidal anti-inflammatory drugs on the basis of each treatment group (artificial hip replacement group, artificial knee arthroplasty group) (Group A) and non - steroidal anti - inflammatory drugs were administered in combination with multimodal analgesic treatment (group B). Detailed records of patients with history, before the medication information, demographic information, physical examination and so on. Two groups were given conventional analgesic pump after surgery, group A patients were given only non-steroidal anti-inflammatory drug treatment. Group B patients were injected with analgesic drugs at the end of the procedure. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

a. 中国成年受试者,年龄≥18岁,性别不限 b. 目标关节须接受人工全髋关节置换术、人工全膝关节置换术,有近期的X线检查作为诊断依据; c. 未经过除赛来昔布胶囊治疗的其他缓解疼痛治疗(药物、针灸及其他物理治疗) d. 受试者能理解和签署已被独立伦理委员会批准的知情同意书。注:也可由受试者合法授权代表提供知情同意。 e. 于出院后依旧能够来院进行院内访视者。 

Inclusion criteria

1. Chinese adult subjects, aged ≥18 years old male and female; 2. Target joint to be subjected to total hip arthroplasty, artificial total knee arthroplasty, a recent X-ray examination as a diagnostic basis; 3. Other pain relief treatments (drugs, acupuncture and other physical therapy) that have not been treated with roxecoxibraside; 4. Subjects can understand and sign informed consent that has been approved by the Independent Ethics Committee. Note: Informed consent may also be provided by the legally authorized representative of the subject; 5. After the hospital can still go to hospital for hospital visits. 

排除标准:

a. 受试者为>1处关节同期置换者(双侧髋、膝关节置换;同侧髋、膝关节置换等); b. 有哮喘、荨麻疹或使用阿司匹林或其他非甾体类抗炎药后有过敏反应病史; c. 有临床意义的下肢静脉或淋巴回流障碍; d. 怀孕或哺乳期女性; e. 对多模式镇痛药物过敏者 f. 糖尿病术后控制不佳者 g. 既往有消化系统溃疡、出血者 h. 其他特殊情况及拒绝签署知情同意书者 

Exclusion criteria:

1. Subjects> 1 joint replacement (bilateral hip, knee replacement; ipsilateral hip, knee replacement, etc.); 2. With asthma, urticaria or the use of aspirin or other non-steroidal anti-inflammatory drugs after a history of allergic reactions; 3. Clinically significant lower limb venous or lymphatic reflux disorder; 4. Pregnant or lactating women; 5. Symptoms of multimodal analgesic drugs; 6. Diabetes is poorly controlled; 7. There are previous digestive system ulcers, bleeding; 8. Other special circumstances and refusal to sign informed consent. 

研究实施时间:

Study execute time:

From2013-01-01To  

征募观察对象时间:

Recruiting time:

From2013-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

THA实验组

样本量:

43

Group:

THA Experimental group

Sample size:

干预措施:

术中局部注射镇痛药物

干预措施代码:

Intervention:

Intraoperative injection of analgesic drugs

Intervention code:

组别:

TKA实验组

样本量:

55

Group:

TKA Experimental group

Sample size:

干预措施:

术中局部注射镇痛药物

干预措施代码:

Intervention:

Intraoperative injection of analgesic drugs

Intervention code:

组别:

THA对照组

样本量:

43

Group:

THA Control group

Sample size:

干预措施:

注射等量生理盐水

干预措施代码:

Intervention:

Equal amount of normal saline

Intervention code:

组别:

TKA对照组

样本量:

55

Group:

TKA Control group

Sample size:

干预措施:

注射等量生理盐水

干预措施代码:

Intervention:

Equal amount of normal saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西安交通大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

Second Affiliated Hospital of Xi'an Jiaotong University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

数字评分量表得分

指标类型:

主要指标 

Outcome:

Numeric Rating Scale scores

Type:

Primary indicator 

测量时间点:

术后12h-术后14天

测量方法:

量表评分

Measure time point of outcome:

12 hours after surgery to 14 days after surgery

Measure method:

Scale score

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

length of postoperative hospital stay

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:

主要指标 

Outcome:

WOMAC 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:

满意度评分

指标类型:

主要指标 

Outcome:

Satisfaction score

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 80 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):

由计算机生成随机数列,在确定纳入一个病例后才能进行随机数字的分配。

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

A random number is generated by the computer. After the inclusion of a case, the random number allocation can be carried out. The random envelopes are used to group the packets. After the random scheme is written, the packets are coded in sequence.

盲法:

为及时恰当地处理研究对象可能发生的意外问题,本研究采用单盲法,即受试者不知情,而治疗者知道分组且可以根据患者出现的情况及时给予治疗。

Blinding:

In order to deal with the possible problems of the study object in time and in a timely manner, this study uses a single-blind approach, that is, the subject is unaware, and the therapist knows the grouping and can be treated in time according to the condition of the patient

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):

resman平台,http://www.medresman.org/login.aspx

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

resman,http://www.medresman.org/login.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:

resman数据平台管理

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

resman

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-08-01
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