今天是:2018-07-22 星期日

腰方肌阻滞VS腹横肌平面阻滞对腹腔镜结/直肠癌根治术患者术后快速康复的前瞻性随机对照研究
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注册号:

Registration number:

ChiCTR1800014436 

最近更新日期:

Date of Last Refreshed on:

2018-03-08 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

腰方肌阻滞VS腹横肌平面阻滞对腹腔镜结/直肠癌根治术患者术后快速康复的前瞻性随机对照研究 

Public title:

Effects of quaratus lumborum block versus transversus abdominis plane block on enhanced recovery after laparoscopic radical resection of colorectal cancer : A prospective randomized controlled study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

腰方肌阻滞VS腹横肌平面阻滞对腹腔镜结/直肠癌根治术患者术后快速康复的前瞻性随机对照研究 

Scientific title:

Effects of quaratus lumborum block versus transversus abdominis plane block on enhanced recovery after laparoscopic radical resection of colorectal cancer : A prospective randomized controlled study  

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:

邓伟 

研究负责人:

余树春 

Applicant:

Wei Deng 

Study leader:

Shuchun Yu 

申请注册联系人电话:

Applicant telephone:

+86 13361656372 

研究负责人电话:

Study leader's telephone:

+86 15390895160 

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:

1050129427@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yscdoc@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:

江西省南昌市东湖区民德路1号 

研究负责人通讯地址:

江西省南昌市东湖区民德路1号 

Applicant address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, China 

Study leader's address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Nanchang 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:

2018-07 

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:

南昌大学第二附属医院伦理委员会 

Name of the ethic committee:

The ethic committee of the Second Affiliated Hospital of Nanchang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-05 

伦理委员会联系人:

葛晓珍 

Contact Name of the ethic committee:

Ge Xiaozhen 

伦理委员会联系地址:

江西省南昌市东湖区民德路1号 

Contact Address of the ethic committee:

1 Minde Road, Donghu District, Nanchang, Jiangxi  

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:

南昌大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Nanchang University 

研究实施负责(组长)单位地址:

江西省南昌市东湖区民德路1号 

Primary sponsor's address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, 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):

江西

市(区县):

Country:

China

Province:

Jiangxi

City:

单位(医院):

南昌大学第二附属医院

具体地址:

江西省南昌市东湖区民德路1号

Institution
hospital:

The Second Affiliated Hospital of Nanchang University

Address:

1 Minde Road, Donghu District, Nanchang, Jiangxi, China

经费或物资来源:

南昌大学科研基金项目 

Source(s) of funding:

Scientific Fund of Nanchang University 

研究疾病:

结/直肠癌 

Target disease:

colorectal cancer 

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:

比较腰方肌阻滞和腹横肌平面阻滞用于腹腔镜结/直肠癌根治术患者术后快速康复的效果 

Objectives of Study:

To compare the effects of quaratus lumborum block versus transversus abdominis plane block on enhanced recovery after laparoscopic radical resection of colorectal cancer 

药物成份或治疗方案详述:

0.375% 罗哌卡因 

Description for medicine or protocol of treatment in detail:

0.375% Ropivacaine 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

年龄40-80岁,BMI 18~30kg/m2,ASA I~III级,全麻下行腹腔镜结/直肠癌根治术。 

Inclusion criteria

Aged 40-80 years, BMI 18-30 kg/m2 ASA I-III, scheduled for radical resection of colorectal caner under general anesthesia 

排除标准:

对罗哌卡因过敏,术前BMI>40kg/m2,穿刺部位感染,近期使用抗精神病类药物、酗酒或滥用药物,语言沟通障碍者,超声显示解剖结构不清 

Exclusion criteria:

Allergy to ropivacaine, BMI>40kg/m2 before operation,puncture site infection, recent use of antipsychotic drugs, alcoholism, or drug abuse, language communication handicapped, ultrasound showed that the anatomical structure was not clear  

研究实施时间:

Study execute time:

From2018-01-12To 2018-07-11 

干预措施:

Interventions:

组别:

腰方肌阻滞组

样本量:

40

Group:

QL

Sample size:

干预措施:

双侧腰方肌阻滞注入0.375%罗哌卡因20ml

干预措施代码:

Intervention:

Bilateral quaratus lumborum block with 0.375% ropivacaine 20ml

Intervention code:

组别:

腹横肌平面阻滞

样本量:

40

Group:

TAP

Sample size:

干预措施:

双侧腹横肌平面阻滞注入0.375%罗哌卡因20ml

干预措施代码:

Intervention:

Bilateral transversus abdominis plane block with 0.375% ropivacaine 20ml

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江西 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

南昌大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后疼痛评分

指标类型:

主要指标 

Outcome:

Visual analogue pain scale (VAS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中丙泊酚用量

指标类型:

次要指标 

Outcome:

intraoperative propofol consumption

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切皮前后血压和心率变化

指标类型:

次要指标 

Outcome:

the variation of blood pressure and heart rate before and after incision

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肛门排气时间

指标类型:

次要指标 

Outcome:

anus 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:

术后镇痛满意度评分

指标类型:

次要指标 

Outcome:

postoperative analgesia 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:

术后住院时间

指标类型:

次要指标 

Outcome:

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:

局麻药中毒

指标类型:

副作用指标 

Outcome:

toxcity of local anesthetics

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心呕吐

指标类型:

副作用指标 

Outcome:

nausea and vomiting

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次下床活动时间

指标类型:

次要指标 

Outcome:

the first time to get out of bed

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中瑞芬太尼用量

指标类型:

主要指标 

Outcome:

intraoperative remifentanil consumption

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 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):

计算机产生随机数字序列表

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

the computer generates random number sequence table

盲法:

Blinding:

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):

采用chictr.org.cn网络平台公开

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

open the IPD on chictr.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:

数据通过CRF表格记录,并由实验助理人员负责管理

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

the primary data were collected on Case-Report Form (CRF), which will be saved and managed by an assisant

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-01-13
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