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优化胸椎旁神经阻滞方案对肺癌根治术患者早期快速康复及远期临床转归的影响
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注册号:

Registration number:

ChiCTR1900026213 

最近更新日期:

Date of Last Refreshed on:

2019-09-26 

注册时间:

Date of Registration:

2019-09-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

优化胸椎旁神经阻滞方案对肺癌根治术患者早期快速康复及远期临床转归的影响 

Public title:

Effect of optimized thoracic paravertebral nerve block on early and rapid recovery and long-term clinical outcome of radical lung cancer patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

优化胸椎旁神经阻滞方案对肺癌根治术患者早期快速康复及远期临床转归的影响 

Scientific title:

Effect of optimized thoracic paravertebral nerve block on early and rapid recovery and long-term clinical outcome of radical lung cancer patients 

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:

张伟 

研究负责人:

张伟 

Applicant:

Zhang Wei 

Study leader:

Zhang Wei 

申请注册联系人电话:

Applicant telephone:

+86 13838299702 

研究负责人电话:

Study leader's telephone:

+86 13838299702 

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:

myhope2005@163.com 

研究负责人电子邮件:

Study leader's E-mail:

myhope2005@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:

河南省郑州市纬五路7号 

研究负责人通讯地址:

河南省郑州市纬五路7号 

Applicant address:

7 Weiwu Road, Zhengzhou, Henan  

Study leader's address:

7 Weiwu Road, Zhengzhou, Henan  

申请注册联系人邮政编码:

Applicant postcode:

450003 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

河南省人民医院 

Applicant's institution:

Henan Provincial People's Hospital 

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:

(2019)伦审第(41)号 

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:

河南省人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Henan Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-24 

伦理委员会联系人:

李立 

Contact Name of the ethic committee:

Li Li 

伦理委员会联系地址:

河南省郑州市纬五路7号 

Contact Address of the ethic committee:

7 Weiwu Road, Zhengzhou, Henan  

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:

河南省人民医院 

Primary sponsor:

Henan Provincial People's Hospital 

研究实施负责(组长)单位地址:

河南省郑州市纬五路7号 

Primary sponsor's address:

7 Weiwu Road, Zhengzhou, Henan  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

河南省人民医院

具体地址:

纬五路7号

Institution
hospital:

Henan Provincial People's Hospital

Address:

7 Weiwu Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

肺癌 

Target disease:

Lung 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:

评价优化胸椎旁神经阻滞方案对肺癌根治术患者快速康复及远期临床转归的影响,探索神经阻滞麻醉在改善围术期镇痛的同时,是否能通过抑制疼痛导致的应激反应和炎性反应,进而改善肿瘤微环境,最终影响肺癌患者术后复发和转移。通过本项目的实施,将在国内首次探索TPVB与肿瘤微环境的关系,为围术期改善肺癌肿瘤微环境提供临床依据,为肺癌根治术患者的远期康复提供参考依据。 

Objectives of Study:

Evaluation by the thoracic nerve block and optimization scheme, rapid recovery and long-term clinical outcome in patients with lung cancer treated, the influence of the exploration of nerve block anesthesia at the same time of improving perioperative analgesic, can inhibit the pain caused by the stress reaction and inflammatory reaction, thus improve the tumor microenvironment, ultimately affect the postoperative recurrence and metastasis in patients with lung cancer. Through the implementation of this project, the relationship between TPVB and tumor microenvironment will be explored for the first time in China, so as to provide clinical basis for perioperative improvement of lung cancer tumor microenvironment and provide reference basis for long-term rehabilitation of patients undergoing radical lung cancer 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:

1. 择期胸腔镜下肺癌根治术患者; 2. 性别不限,年龄18-64岁,体重指数18-25kg/m2; 3. ASA分级II或III级; 4. 用力肺活量>80%预计值,第一秒呼气率>70%预计值; 5. 术前肺癌诊断明确,肿瘤直径大于1cm; 6. 自愿参加试验并签署知情同意书。 

Inclusion criteria

1. Patients with elective thoracoscopic radical lung cancer surgery; 2. Aged 18-64 years, body mass index 18-25kg/m2; 3. ASA grade II or III; 4. 80% estimated value of forced lung capacity >, 70% estimated value of expiratory rate > in the first second; 5. Definite preoperative diagnosis of lung cancer, tumor diameter greater than 1cm. 6. Willing to participate in the trial and sign infored consent. 

排除标准:

1. 交流障碍、无法配合研究者,如语言理解障碍、精神疾病等; 2. 术前放化疗病史; 3. 严重心脑血管疾病; 4. 糖尿病、血液病及其他代谢障碍性疾病史; 5. 高血压、慢性阻塞性或(和)限制性肺病; 6. 术前2周内吸烟史, 7. 既往有其他手术史。 

Exclusion criteria:

1. Communication disorders, inability to cooperate with researchers, such as language comprehension disorders, mental disorders, etc.; 2. Preoperative history of chemoradiotherapy; 3. Serious cardiovascular and cerebrovascular diseases; 4. History of diabetes, blood diseases and other metabolic disorders; 5. History of hypertension, no chronic obstructive or (and) restrictive lung disease; 6. Smoking history within 2 weeks before surgery; 7. Previous history of other operations. 

研究实施时间:

Study execute time:

From2019-10-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2019-10-01To 2019-12-31 

干预措施:

Interventions:

组别:

七氟醚组

样本量:

55

Group:

Sevoflurane

Sample size:

干预措施:

七氟醚

干预措施代码:

Intervention:

Sevoflurane

Intervention code:

组别:

七氟醚+胸椎旁神经阻滞

样本量:

55

Group:

Sevoflurane+TPVB

Sample size:

干预措施:

七氟醚+胸椎旁神经阻滞

干预措施代码:

Intervention:

Sevoflurane+TPVB

Intervention code:

组别:

七氟醚+优化胸椎旁神经阻滞

样本量:

55

Group:

Sevoflurane+Optimized TPVB

Sample size:

干预措施:

七氟醚+优化胸椎旁神经阻滞

干预措施代码:

Intervention:

Sevoflurane+Optimized TPVB

Intervention code:

组别:

丙泊酚

样本量:

55

Group:

Propfol

Sample size:

干预措施:

丙泊酚

干预措施代码:

Intervention:

Propofol

Intervention code:

组别:

丙泊酚+胸椎旁神经阻滞

样本量:

55

Group:

Propofol+TPVB

Sample size:

干预措施:

丙泊酚+胸椎旁神经阻滞

干预措施代码:

Intervention:

Propofol+TPVB

Intervention code:

组别:

丙泊酚+优化胸椎旁神经阻滞

样本量:

55

Group:

Propofol+Optimized TPVB

Sample size:

干预措施:

丙泊酚+优化胸椎旁神经阻滞

干预措施代码:

Intervention:

Propofol+Optimized TPVB

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

Stay duration in hospital

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无病生存期

指标类型:

次要指标 

Outcome:

Disease-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

Overall survival

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

指标类型:

次要指标 

Outcome:

Life quality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

次要指标 

Outcome:

postoperative complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

Patient Satisfaction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性痛发生率

指标类型:

次要指标 

Outcome:

Incidence of chronic 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:

住院花费

指标类型:

次要指标 

Outcome:

Hospital cost

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤微环境标记物

指标类型:

次要指标 

Outcome:

Tumor microenviromental marker

Type:

Secondary indicator 

测量时间点:

测量方法:

基因测序

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

组织:

Sample Name:

Tissue

Tissue:

Lung

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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:

标本中文名:

支气管灌洗液

组织:

Sample Name:

bronchoalveolar lavage fluid

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 65 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):

由专人采用统计软件进行分层区组随机化分组

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

The stratified groups were randomized by using statistical software

盲法:

双盲

Blinding:

Double blind

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):

2020.6.31,纸质公开

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

2020.6.31, paper public

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:

数据采集:CRF 数据管理:EDC

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

Data collect: CRF Data management: EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-09-26
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