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连续收肌管阻滞联合膝关节腔内注药用于膝关节单髁置换术后镇痛的研究
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注册号:

Registration number:

ChiCTR-IOR-16008720 

最近更新日期:

Date of Last Refreshed on:

2016-06-25 

注册时间:

Date of Registration:

2016-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

连续收肌管阻滞联合膝关节腔内注药用于膝关节单髁置换术后镇痛的研究 

Public title:

The Application of Continious Adductor Canal Blockade Associated with Local Infiltration Analgesia for Postoperative Analgeisia Management After Unicompartmental Knee Arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

连续收肌管阻滞联合膝关节腔内注药用于膝关节单髁置换术后镇痛的研究 

Scientific title:

The Application of Continious Adductor Canal Blockade Associated with Local Infiltration Analgesia for Postoperative Analgeisia Management After Unicompartmental 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:

兰飞 

研究负责人:

王天龙 

Applicant:

Lan Fei 

Study leader:

Wang Tian-long 

申请注册联系人电话:

Applicant telephone:

+86 18511508342 

研究负责人电话:

Study leader's telephone:

+86 13910525304 

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:

lanfei206@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

w_tl5595@hotmail.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:

北京市西城区长椿街45号首都医科大学宣武医院 

研究负责人通讯地址:

北京市西城区长椿街45号首都医科大学宣武医院  

Applicant address:

45 Changchun Street, Xicheng District, Beijing 

Study leader's address:

45 Changchun Street, Xicheng District, Beijing 

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:

首都医科大学宣武医院麻醉手术科 

Applicant's institution:

the Department of Anesthesiology and Operating Theatre, Xuanwu Hospital of Capital Medical University  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

首都医科大学宣武医院 

Primary sponsor:

Xuanwu Hospital of Capital Medical University  

研究实施负责(组长)单位地址:

北京市西城区长椿街45号 

Primary sponsor's address:

45 Changchun Street, Xicheng District, Beijing 

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):

西城区

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学宣武医院

具体地址:

北京市西城区长椿街45号首都医科大学宣武医院

Institution
hospital:

Xuanwu Hospital of Capital Medical University

Address:

45 Changchun Street, Xicheng District, Beijing

经费或物资来源:

医院院内课题资助 

Source(s) of funding:

Support was received solely from institutional sources. 

研究疾病:

重度骨性膝关节炎 

Target disease:

Severe Osteoarthritis KneeArthritis 

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:

主要研究在膝关节单髁置换术后采用连续收肌管阻滞的镇痛效果,是否可有效的组合为多模式镇痛方案,使术后NRS疼痛评分优化3分。 次要研究目的为研究该种围术期镇痛方案,患者补救药物需要量,镇痛相关不良反应,该种方案患者的满意度、术后早期运动能力及恢复效果、住院天数,以及出院时患者的恢复程度。 

Objectives of Study:

To research the effect of continious adductor canal blockade associated with local infiltration analgesia after unicompartmental knee arthroplasty,and to optimize multimodal anagesia scheme. 

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:

ASAⅠ-III级,年龄50-75岁,拟在椎管内麻醉下行膝关节单髁置换术 

Inclusion criteria

(1) ASA physical status 1 to 3; (2) Aged 50-75 years old; (3) Patients were sheduled for unicompartmental knee arthroplasty surgery under Intrathecal Anesthesia. 

排除标准:

严重的心血管疾病,肝肾功能明显异常,药物和酒精滥用史,不能合作的患者,凝血功能异常,局麻药过敏,外周神经损伤或病变的患者 

Exclusion criteria:

(1) Severe cardiovascular disease; (2) Significant renal or hepatic impairment; (3) History of drug and alcohol abuse; (4) Patients cannot cooperation; (5) Preoperative coagulation dysfunction; (6) Allergies to local anesthetics or dexmedetomidine; (7) Peripheral nerve injury or underlying injury.  

研究实施时间:

Study execute time:

From2016-08-01To 2018-01-31 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2018-01-31 

干预措施:

Interventions:

组别:

连续收肌管阻滞组

样本量:

19

Group:

ACB Group

Sample size:

干预措施:

0.2%罗哌卡因连续收肌管阻滞

干预措施代码:

Intervention:

Continious 0.2% Ropivacaine blockade adductor canal

Intervention code:

组别:

假手术组

样本量:

19

Group:

Sham Group

Sample size:

干预措施:

等量生理盐水

干预措施代码:

Intervention:

Same amount of saline as treatment agents

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(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学宣武医院 

单位级别:

三级甲等 

Institution
hospital:

Xuanwu Hospital of Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后24h内活动时最高的NRS评分

指标类型:

主要指标 

Outcome:

Worst pain during movement in the operated knee during first 24h postoperative

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后首次NRS>3分的时间

指标类型:

次要指标 

Outcome:

Time from the end of surgery until breakthrough 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:

术后静息下疼痛评分

指标类型:

次要指标 

Outcome:

NRS score at rest

Type:

Secondary indicator 

测量时间点:

术后4h、8h、12h、24h、48h、72h

测量方法:

NRS评分

Measure time point of outcome:

4h, 8h, 12h, 24h, 48h, 72hrs after surgery

Measure method:

Numerical rating scale

指标中文名:

术后活动下疼痛评分

指标类型:

次要指标 

Outcome:

NRS score during movement

Type:

Secondary indicator 

测量时间点:

术后4h、8h、12h、24h、48h、72h

测量方法:

NRS评分

Measure time point of outcome:

4h, 8h, 12h, 24h, 48h, 72hrs after surgery

Measure method:

Numerical rating scale

指标中文名:

补救药物剂量

指标类型:

次要指标 

Outcome:

Dose of rescue medicine

Type:

Secondary indicator 

测量时间点:

术后4h、8h、12h、24h、48h、72h 测量方

测量方法:

Measure time point of outcome:

4h, 8h, 12h, 24h, 48h, 72hrs after surgery

Measure method:

指标中文名:

TUG实验

指标类型:

次要指标 

Outcome:

Time Up & Go Test

Type:

Secondary indicator 

测量时间点:

术后第一天、第二天、第三天

测量方法:

Measure time point of outcome:

Postoperative Day1, Postoperative Day2, Postoperative Day3

Measure method:

指标中文名:

10米快步走实验

指标类型:

次要指标 

Outcome:

10 m Walk

Type:

Secondary indicator 

测量时间点:

术后第一天、第二天、第三天

测量方法:

Measure time point of outcome:

Postoperative Day1, Postoperative Day2, Postoperative Day3

Measure method:

指标中文名:

30秒站坐实验

指标类型:

次要指标 

Outcome:

30s Chair Stand test

Type:

Secondary indicator 

测量时间点:

术后第一天、第二天、第三天

测量方法:

Measure time point of outcome:

Postoperative Day1, Postoperative Day2, Postoperative Day3

Measure method:

指标中文名:

住院期间步行总距离

指标类型:

次要指标 

Outcome:

Ambulation distance at discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院期间膝关节最大弯曲角度

指标类型:

次要指标 

Outcome:

Maximum flexion at discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

Length of hospital stays

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:

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 50 years
最大 Max age 75 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):

Using a computer-generated sequence of random numbers and a sealed envelope technique

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否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):

通过公共平台实现共享,当试验发表后任何人以科研目的均可索要试验结果和方法

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

The data would be share to the public by the public platform, and any teaching centre could ask for the data and protocol after the publication of the study

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:

 2016-06-25
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