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超声引导下盆腔神经阻滞麻醉在前列腺穿刺活检中的应用
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注册号:

Registration number:

ChiCTR-IOR-17013533 

最近更新日期:

Date of Last Refreshed on:

2017-11-24 

注册时间:

Date of Registration:

2017-11-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

超声引导下盆腔神经阻滞麻醉在前列腺穿刺活检中的应用 

Public title:

Application of pelvic plexus block k in transperineal template-guided prostate biopsy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声引导下盆腔神经阻滞麻醉在前列腺穿刺活检中的应用 

Scientific title:

Application of pelvic plexus block k in transperineal template-guided prostate biopsy 

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:

丁雪飞 

研究负责人:

丁雪飞 

Applicant:

Ding Xue-fei 

Study leader:

Ding Xue-fei 

申请注册联系人电话:

Applicant telephone:

+86 18051061234 

研究负责人电话:

Study leader's telephone:

+86 18061061234 

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:

xuefeid@126.com 

研究负责人电子邮件:

Study leader's E-mail:

xuefeid@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:

江苏省扬州市南通西路98号 

研究负责人通讯地址:

江苏省扬州市南通西路98号 

Applicant address:

98 Nantong Road West, Yangzhou, Jiangsu, China 

Study leader's address:

98 Nantong Road West, Yangzhou, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

225001 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

江苏省苏北人民医院 

Applicant's institution:

Subei People's Hospital of Jiangsu province 

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:

2016KY-013 

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:

苏北人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Northern Jiangsu People's Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

江苏省扬州市南通西路98号 

Contact Address of the ethic committee:

98 Nantong Road West, Yangzhou, Jiangsu, 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:

江苏省苏北人民医院 

Primary sponsor:

Subei People's Hospital of Jiangsu province 

研究实施负责(组长)单位地址:

江苏省扬州市南通西路98号 

Primary sponsor's address:

98 Nantong Road West, Yangzhou, Jiangsu, 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):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省苏北人民医院

具体地址:

江苏省扬州市南通西路98号

Institution
hospital:

Subei People's Hospital of Jiangsu province

Address:

98 Nantong Road West, Yangzhou, Jiangsu, China

经费或物资来源:

江苏省卫生计生委科研课题 

Source(s) of funding:

Jiangsu Provincial Commission of Health and Family Planning Project 

研究疾病:

前列腺癌 

Target disease:

prostate 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:

其它 

Study phase:

N/A 

研究目的:

探讨盆腔神经阻滞麻醉在经直肠超声引导下的经会阴前列腺穿刺活检中的麻醉效果。 

Objectives of Study:

To evaluate the anesthetic efficacy of pelvic plexus block (PPB) in transperineal template-guided prostate biopsy (TTPB). 

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)直肠指检发现结节;(2)超声、CT、MRI检查发现前列腺内异常影像;(3)前列腺特异性抗原(prostate specific antigen,PSA)>10μg/L;(4) PSA4~10 μg/L,游离PSA与总PSA比值异常或PSA密度值异常。 

Inclusion criteria

Study inclusion criteria were digital rectal examination finds nodules with any prostate-specific antigen (PSA) value; B ultrasound or CT or MRI examination reveals abnormal images with any PSA value; PSA >10mg/L with any free/total (f/t) PSA and prostate specific antigen density (PSAD); PSA range from 4 to 10mg/L with abnormal f/t PSA or PSAD value 

排除标准:

(1)既往有前列腺穿刺活检史;(2)慢性前列腺/骨盆疼痛;(3)严重心脑血管疾病或有凝血功能异常者;(4)严重泌尿系统感染;(5)利多卡因过敏史。 

Exclusion criteria:

Exclusion criteria were previous prostate biopsies, chronic prostatitis, chronic pelvic pain syndrome, active urinary tract infection, bleeding disorder, and allergy to local anesthetic.  

研究实施时间:

Study execute time:

From2016-07-01To 2017-11-30 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2017-11-01 

干预措施:

Interventions:

组别:

前列腺包膜局部麻醉组

样本量:

81

Group:

prostate-coated local anesthesia

Sample size:

干预措施:

局部麻醉

干预措施代码:

Intervention:

local anaesthesia

Intervention code:

组别:

前列腺周围神经阻滞麻醉组

样本量:

83

Group:

periprostatic nerve block group

Sample size:

干预措施:

阻滞麻醉

干预措施代码:

Intervention:

block anaesthesia

Intervention code:

组别:

盆腔神经阻滞麻醉组

样本量:

81

Group:

pelvic plexus block group

Sample size:

干预措施:

阻滞麻醉

干预措施代码:

Intervention:

block anaesthesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

江苏省苏北人民医院 

单位级别:

三级甲等 

Institution
hospital:

Subei People's Hospital of Jiangsu province  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视觉数字评分法

指标类型:

主要指标 

Outcome:

visual numeric scale

Type:

Primary indicator 

测量时间点:

穿刺时及穿刺后半小时

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

visual analogue scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

-

指标类型:

主要指标 

Outcome:

-

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

采用随机数字法将患者分为3组

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

The patients were randomised by an independent investigator with the help of a computer programme into three groups

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是Yes

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):

ResMan

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

ResMan

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:

ResMan

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

ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-11-24
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