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超声引导竖脊肌阻滞用于结肠癌加速康复外科手术中的镇痛范围及效果评估
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注册号:

Registration number:

ChiCTR2000031255 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

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:

超声引导竖脊肌阻滞用于结肠癌加速康复外科手术中的镇痛范围及效果评估 

Public title:

Analgesic Range and Effect Evaluation of Ultrasound-Guided Erector Spinae Block on Enhanced Recovery After Surgery for Colon Cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导竖脊肌阻滞用于结肠癌加速康复外科手术中的镇痛范围及效果评估的单中心、前瞻性、随机、对照临床研究  

Scientific title:

Analgesic Range and Effect Evaluation of Ultrasound-Guided Erector Spinae Block on Enhanced Recovery After Surgery for Colon Cancer: a Single-Center, Prospective, 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:

李其金 

研究负责人:

莫平 

Applicant:

Li Qijin 

Study leader:

Mo Ping 

申请注册联系人电话:

Applicant telephone:

+86 13824411268 

研究负责人电话:

Study leader's telephone:

+86 13928665645 

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:

214111799@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

pop_pan@126.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:

广东省佛山市佛平路40号 

研究负责人通讯地址:

广东省佛山市佛平路40号 

Applicant address:

40 Foping Road, Foshan, Guangdong, China  

Study leader's address:

40 Foping Road, Foshan, Guangdong, China  

申请注册联系人邮政编码:

Applicant postcode:

528200 

研究负责人邮政编码:

Study leader's postcode:

528200 

申请人所在单位:

南方医科大学附属南海医院 

Applicant's institution:

Medical Ethics Committee of Affiliated Nanhai Hospital of Southern Medical 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:

2019102 

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:

南方医科大学附属南海医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Affiliated Nanhai Hospital of Southern Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-01 

伦理委员会联系人:

张奕超 

Contact Name of the ethic committee:

Yichao Zhang 

伦理委员会联系地址:

广东省佛山市佛平路40号 

Contact Address of the ethic committee:

40 Foping Road, Foshan, Guangdong, 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:

南方医科大学附属南海医院 

Primary sponsor:

Medical ethics committee of Affiliated Nanhai Hospital of Southern Medical University  

研究实施负责(组长)单位地址:

广东省佛山市佛平路40号 

Primary sponsor's address:

40 Foping Road, Foshan, Guangdong, 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):

广东省

市(区县):

佛山市

Country:

China

Province:

Guangdong

City:

Foshan

单位(医院):

南方医科大学附属南海医院

具体地址:

佛平路40号

Institution
hospital:

Affiliated Nanhai Hospital of Southern Medical University

Address:

40 Foping Road

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

结肠癌 

Target disease:

colon 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:

探索性研究/预试验 

Study phase:

研究目的:

综合评估超声引导竖脊肌阻滞的镇痛范围及效果,明确其镇痛机理及最优麻醉剂量,探究超声引导竖脊肌阻滞在腹腔镜结肠癌根治术加速康复外科中的应用价值。 

Objectives of Study:

To comprehensively evaluate the analgesic scope and effect of ultrasound-guided bilateral erector spinae plane block, clarify its analgesic mechanism and optimal anesthetic dose, and explore the application value of ultrasound-guided erector spinal block in laparoscopic radical operation of colon cancer and accelerated rehabilitation surgery. 

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:

年龄18~75岁的患者;美国标准协会(ASA)分级为Ⅰ~Ⅱ级;心功能纽约心脏病协会(NYHA)分级I~Ⅱ级;择期行腹腔镜结肠癌根治术;患者或家属签署知情同意书。 

Inclusion criteria

Patients aged 18 to 75 years; ASA class for I- II; NYHA class I - II; Laparoscopic radical operation of colon cancer; The patient or family member signs the informed consent. 

排除标准:

凝血功能异常者;严重心肺疾病;肝肾功能不全者;对局麻药物或阿片类药物过敏者;术前接受放化疗者;无法配合或沟通困难者;慢性疼痛或精神病史长期服药者;出现严重并发症导致住院时间延长者。 

Exclusion criteria:

Abnormal coagulation function; Severe heart and lung disease, liver and kidney dysfunction; Allergic to local anesthetic drugs or opioids; Preoperative chemoradiotherapy; Inability to cooperate or communicate with difficulty; Chronic pain or a long history of mental illness; Serious complications resulted in prolonged hospital stay. 

研究实施时间:

Study execute time:

From2020-04-01To 2021-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

超声引导下T7横突水平竖脊肌深面注射0.25%罗哌卡因20mL。

干预措施代码:

Intervention:

Under ultrasonic guidance, 20mL 0.25% ropivacaine was injected into the deep surface of T7 transverse process horizontal erector spine muscle:

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

超声引导下T7横突水平竖脊肌深面注射生理盐水20mL

干预措施代码:

Intervention:

Under ultrasonic guidance, 20mL saline was injected into the deep surface of T7 transverse process horizontal erector spine muscle

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

佛山市 

Country:

China 

Province:

Guangdong 

City:

Foshan 

单位(医院):

南方医科大学附属南海医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Nanhai Hospital of Southern Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

视觉模拟量表

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

术后2h、6h、12h、24h、48h

测量方法:

Measure time point of outcome:

after operation 2h, 6h, 12h, 24h, 48h

Measure method:

指标中文名:

舒适度评分

指标类型:

主要指标 

Outcome:

BCS

Type:

Primary indicator 

测量时间点:

术后2h、6h、12h、24h、48h

测量方法:

Measure time point of outcome:

after operation 2h, 6h, 12h, 24h, 48h

Measure method:

指标中文名:

术后酮咯酸总镇痛消耗量

指标类型:

主要指标 

Outcome:

Total postoperative analgesic consumption of ketoroic acid

Type:

Primary indicator 

测量时间点:

术后48h内

测量方法:

Measure time point of outcome:

Within 48h after surgery

Measure method:

指标中文名:

温度觉

指标类型:

主要指标 

Outcome:

Thermesthesia

Type:

Primary indicator 

测量时间点:

阻滞后6、12、24h

测量方法:

Measure time point of outcome:

6, 12, 24h after block

Measure method:

指标中文名:

痛觉

指标类型:

主要指标 

Outcome:

algesia

Type:

Primary indicator 

测量时间点:

阻滞后6、12、24h

测量方法:

Measure time point of outcome:

6, 12, 24h after block

Measure method:

指标中文名:

血流动力学指标

指标类型:

主要指标 

Outcome:

Hemodynamic index

Type:

Primary indicator 

测量时间点:

入室(T1)、麻醉诱导后5min(T2)、切皮后2min(T3)、术毕(T4)

测量方法:

Measure time point of outcome:

When entering the operating room, 5 minutes after anesthesia induction, 2 minutes after skin cutting, and after operation

Measure method:

指标中文名:

创伤应激指标

指标类型:

副作用指标 

Outcome:

Indicators of traumatic stress

Type:

Adverse events 

测量时间点:

入室(T1)、麻醉诱导后5min(T2)、切皮后2min(T3)、术毕(T4)

测量方法:

Measure time point of outcome:

When entering the operating room, 5 minutes after anesthesia induction, 2 minutes after skin cutting, and after operation

Measure method:

指标中文名:

胃肠恢复指标

指标类型:

次要指标 

Outcome:

Gastrointestinal recovery index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中丙泊酚、瑞芬太尼用量

指标类型:

次要指标 

Outcome:

Intraoperative dosage of propofol and remifentanil

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应发生情况

指标类型:

副作用指标 

Outcome:

Adverse reactions occur

Type:

Adverse events 

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

由莫平医生采用随机数表法对符合纳入标准和排除标准的患者进行分组。

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

The random number table was used to group the patients who met the inclusion criteria and exclusion criteria by Dr. Ping M.

盲法:

双盲

Blinding:

Double blind

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):

通过ResMan提供原始数据查询, http://www.medresman.org.cn.

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

IPD will be public accessable via 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:

Excel表格

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

Excel form

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
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