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晚期癌症暴发痛控制现状及临床干预研究
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注册号:

Registration number:

ChiCTR-INC-16008075 

最近更新日期:

Date of Last Refreshed on:

2016-03-08 

注册时间:

Date of Registration:

2016-03-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

晚期癌症暴发痛控制现状及临床干预研究 

Public title:

Current situation and clinical intervention of breakthrough pain in advanced cancer patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

晚期癌症暴发痛控制现状及临床干预研究 

Scientific title:

Current situation and clinical intervention of breakthrough pain in advanced 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:

刘强 

研究负责人:

李玉香 

Applicant:

Liu Qiang 

Study leader:

Li Yuxiang 

申请注册联系人电话:

Applicant telephone:

+8615226208898 

研究负责人电话:

Study leader's telephone:

+8613895605097 

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:

sxliuqiang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

li_yuxiang@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:

宁夏回族自治旗银川市兴庆区胜利街1160号 

研究负责人通讯地址:

宁夏回族自治区银川市兴庆区胜利街双怡苑7-601 

Applicant address:

1160 Shengli Street, Yinchuan, Ningxia autonomous region, China 

Study leader's address:

1160 Shengli Street, Yinchuan, Ningxia autonomous region, China 

申请注册联系人邮政编码:

Applicant postcode:

750004 

研究负责人邮政编码:

Study leader's postcode:

750004 

申请人所在单位:

宁夏医科大学 

Applicant's institution:

Ningxia 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:

2016-143 

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:

宁夏医科大学伦理审查委员会 

Name of the ethic committee:

Ningxia Medical University Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-03-10 

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:

宁夏医科大学总医院肿瘤医院 

Primary sponsor:

Tumer hospital of Ningxia medical university 

研究实施负责(组长)单位地址:

宁夏回族自治区银川市兴庆区胜利街804号 

Primary sponsor's address:

804 Shengli Street, Yinchuan, Ningxia autonomous region, 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):

宁夏回族自治区

市(区县):

银川市

Country:

China

Province:

Ningxia autonomous region

City:

Yinchuan

单位(医院):

宁夏医科大学

具体地址:

宁夏回族自治区银川市兴庆区胜利街1160号

Institution
hospital:

Ningxia medical university

Address:

1160 Shengli Street, Yinchuan, Ningxia autonomous region, China

经费或物资来源:

宁夏回族自治区科技厅 

Source(s) of funding:

Science and Technology Department of Ningxia 

研究疾病:

癌症患者 

Target disease:

Cancer patients 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

本研究拟将稀释氧化亚氮速效镇痛适宜技术应用于骨科和急诊科,分析评价稀释氧化亚氮在创伤操作痛的镇痛效果,尝试将此项技术推广至所有需镇痛时间较短的有创医疗操作中。希望能在我区乃全国将此项急性镇痛适宜技术推广。 

Objectives of Study:

This study aims to test the hypothesis that a fixed nitrous oxide/oxygen mixture will promote better breakthrough cancer pain alleviation and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity during breakthrough pain (primary outcomes). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

年龄18岁以上;疼痛评分VAS≥4的急性创伤、骨科的住院患者;患者创伤不影响使用多功能心电监护仪或脉搏氧监测器;自愿参加并签署知情同意书;患者神志清楚,能够正确理解和使用长海痛尺表达疼痛程度 

Inclusion criteria

Aged 16 and older, either male or femal, pain reported to be 4 or higher (on a scale of 0 to 10), The participants are volunteers and written consent obtained, injured area not affecting the vital signs and digital pulse oximeter monitoring. 

排除标准:

肠梗阻、空气栓塞、气胸、肺癌、气脑造影检查、癫痫、阻塞性呼吸系统疾病及急性上呼吸道感染、孕妇、合并其他严重复合伤及重度吸入性损伤;精神异常的病人;药物性或疾病性肺纤维化的病人;耳鼻喉等器官的疾病,如鼻窦炎,中耳疾患,鼓膜移植以及既往有滥用镇痛药物史 

Exclusion criteria:

Mental disorder, drug dependence and drug abuse,Unconscious and unable to express pain by Changhai pain scale (VAS), Abdominal distension or suspected bowel obstruction, air embolism, pneumothorax,lung cancer, decompression sickness, epilepsy,chronic obstructive pulmonary disease and acute respiratory infection, pregnancy, severe inhalation injury; pharmaceutical or pathological pulmonary fibrosis; Maxillofacial injuries, Ear, nose, larynges diseases such as sinuses, middle ear, tympan graft  

研究实施时间:

Study execute time:

From2016-07-01To 2017-07-01 

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

Control Group

Sample size:

干预措施:

标准治疗+氧气

干预措施代码:

Intervention:

Standard Treatment+Oxygen

Intervention code:

组别:

干预组

样本量:

180

Group:

Intervention Group

Sample size:

干预措施:

标准治疗+氧化亚氮/氧气治疗组

干预措施代码:

Intervention:

Standard Treatmen+Nitrous Oxide/Oxygen

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

宁夏回族自治区 

市(区县):

银川市 

Country:

China 

Province:

Ningxia Autonomous Region 

City:

Yinchuan 

单位(医院):

宁夏医科大学总医院肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Tumer Hospital of Ningxia Medical University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

Analgesia Effect

Type:

Primary indicator 

测量时间点:

操作前、中、后

测量方法:

长海痛尺

Measure time point of outcome:

Before, during and after operation

Measure method:

Changhai Pain Rating Scale

指标中文名:

心率

指标类型:

次要指标 

Outcome:

heart rate

Type:

Secondary indicator 

测量时间点:

操作前、中、后

测量方法:

指端脉氧仪

Measure time point of outcome:

Before, during and after operation

Measure method:

Pulse Oximeters

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood pressure

Type:

Secondary indicator 

测量时间点:

操作前、中、后

测量方法:

血压计

Measure time point of outcome:

Before, during and after operation

Measure method:

sphygmomanometer

指标中文名:

脉氧饱和度

指标类型:

次要指标 

Outcome:

Pulse Oxygen Saturation

Type:

Secondary indicator 

测量时间点:

操作前、中、后

测量方法:

指端脉氧仪

Measure time point of outcome:

Before, during and after operation

Measure method:

Pulse Oximeters

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 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):

将纳入的研究对象按进入顺序编号1-240,每4人为一区组;区组内将有3人进入干预组,1人进入对照组,则每组有24种分配方案,A、B、C组(干预组)、D组(对照组);在线随机数生成器,产生60个随机数(按最大可能,每人只做一次,则需要60组),最小值为1,最大值为24;按随机数对应的方案进行分组—— 对干预组患者在暴发痛时给予标准化癌痛治疗+稀释氧化亚氮吸入,对照组患者在暴发痛时给予标准化癌痛治疗+氧气吸入.

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

A block contains 4 people,three of them random enter the intervention group with the left one enter the control group, there will be 24 distribution schemes for each block. Then use the online Random Number Generation to creat 30 random numbers, with the minimum of 1 and maximum 24.

盲法:

Blinding:

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:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-03-08
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