今天是:2019-11-17 星期日

周申元医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 超声引导下脊神经后支阻滞在脊柱手术中的应用
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注册号:

Registration number:

ChiCTR1900026787 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

周申元医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 超声引导下脊神经后支阻滞在脊柱手术中的应用 

Public title:

A randomized controlled trial to analyze the efficacy of ultrasound-guided dorsal ramus block in spine surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导下脊神经后支阻滞在脊柱手术中的应用 

Scientific title:

A randomized controlled trial to analyze the efficacy of ultrasound-guided dorsal ramus block in spine surgery 

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:

周申元 

研究负责人:

周申元 

Applicant:

Zhou Shenyuan 

Study leader:

Zhou Shenyuan 

申请注册联系人电话:

Applicant telephone:

+86 13482717355 

研究负责人电话:

Study leader's telephone:

+86 13482717355 

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:

chblzhoushenyuan@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

chblzhoushenyuan@sina.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:

上海市南京西路591弄102号3楼 

研究负责人通讯地址:

上海市南京西路591弄102号3楼 

Applicant address:

Third Floor, 102 591st Lane, Nanjing Road West, Shanghai 

Study leader's address:

Third Floor, 102 591st Lane, Nanjing Road West, Shanghai 

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:

上海交通大学附属第六人民医院 

Applicant's institution:

Shanghai Jiaotong University Affiliated Sixth People's Hospital 

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:

上海交通大学附属第六人民医院 

Primary sponsor:

Shanghai Jiaotong University Affiliated Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市宜山路600号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第六人民医院

具体地址:

上海宜山路600号

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District

经费或物资来源:

个人经费 

Source(s) of funding:

personnal funding 

研究疾病:

脊柱手术 

Target disease:

Spine Surgery 

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:

1、在超声引导下寻求脊神经后支阻滞的最佳阻滞方法; 2、明确脊神经后支阻滞对腰椎减压融合手术中体感诱发电位(SSEP)与运动诱发电位(MEPS)的影响; 3、观察脊神经后支阻滞联合全身麻醉在腰椎手术中的镇痛效应。 

Objectives of Study:

1. The best method of ultrasound guided dorsal ramus block in spine surgery; 2. The influence of ultrasound guided dorsal ramus block on somatosensory evoked potential (SSEP) and motor evoked potential (MEPS) in spine surgery; 3. To observe the analgesic effect of ultrasound guided dorsal ramus block in spine 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:

研究对象:选择ASA I~II级,临床诊断为腰突症,于上海市第六人民医院择期行全麻插管下行腰椎减压融合内固定手术患者共计50例,纳入标准包括:年龄20-70岁, BMI 18-23kg/ m2,腰部正中手术切口,手术时长180min以内。 

Inclusion criteria

Subject: a total of 150 patients with ASA grade I ~ II, diagnosed with lumbar protrusion, who receive lumbar decompression and internal fixation surgery under general anesthesia at the sixth people's hospital of Shanghai. The inclusion criteria included: aged 20-70 years, BMI 18-23kg/ m2, median lumbar incision, and operation duration less than 180min. 

排除标准:

患者拒绝或不配合;穿刺部位感染,抗凝药的使用,局麻药过敏,神经系统病变,孕妇或哺乳期妇女。 

Exclusion criteria:

Patients who refused or did not cooperate, infection, usage of anticoagulants, local anesthetic allergies, neurological disorders, and pregnant or lactating women.  

研究实施时间:

Study execute time:

From2019-10-22To  

干预措施:

Interventions:

组别:

试验组

样本量:

25

Group:

experimental group

Sample size:

干预措施:

脊神经后支阻滞

干预措施代码:

Intervention:

dorsal ramus block

Intervention code:

组别:

对照组

样本量:

25

Group:

control

Sample size:

干预措施:

常规全身麻醉

干预措施代码:

Intervention:

general anesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

阿片类用量

指标类型:

主要指标 

Outcome:

consumption of opioid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后疼痛评分

指标类型:

次要指标 

Outcome:

VAS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动诱发电位阈值

指标类型:

主要指标 

Outcome:

threshold of MEP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感觉诱发电位波幅

指标类型:

主要指标 

Outcome:

amplitude of SSEP

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:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 20 years
最大 Max age 70 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):

参与实验临床医生根据事先由软件提供的随机序列号对患者实施干预

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

Doctors who participate in this trial give differnet type of anesthesia for the patient based on random numbers provided by the software.

盲法:

麻醉医师B(主要负责数据记录以及术后随访)、主要研究者和统计分析人员在整个过程中不知道麻醉干预分组。

Blinding:

Blind method for anesthesiologist B (mainly responsible for data recording and postoperative follow-up), main researchers and statisticians.

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):

论文发表6个月后随意向实验者索取

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

within six months after the paper published

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:

数据采集采用电子麻醉记录单及相关实验观察指标记录表,数据管理采用EXCEL表

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

Electronic anesthesia records and experimental observation outcome records were used for data collection, and EXCEL sheet was used for data management

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-22
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