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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
河南省人民医院 |
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Applicant's institution: |
Henan Provincial People's Hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical Ethics Committee of Henan Provincial People's Hospital |
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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 |
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Contact Name of the ethic committee: |
Li Li |
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伦理委员会联系地址: |
河南省郑州市纬五路7号 |
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Contact Address of the ethic committee: |
7 Weiwu Road, Zhengzhou, Henan |
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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 |
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Primary sponsor: |
Henan Provincial People's Hospital |
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研究实施负责(组长)单位地址: |
河南省郑州市纬五路7号 |
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Primary sponsor's address: |
7 Weiwu Road, Zhengzhou, Henan |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-raised |
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研究疾病: |
肺癌 |
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Target disease: |
Lung Cancer |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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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。 |
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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: |
从From2019-10-01至To 2019-12-31 |
征募观察对象时间: Recruiting time: |
从From2019-10-01至To 2019-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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 |