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盐酸纳布啡注射液治疗日间手术术后疼痛的有效性和安全性的多中心、随机、平行、阳性对照临床研究
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注册号:

Registration number:

ChiCTR-IOR-16010032 

最近更新日期:

Date of Last Refreshed on:

2019-04-23 

注册时间:

Date of Registration:

2016-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

盐酸纳布啡注射液治疗日间手术术后疼痛的有效性和安全性的多中心、随机、平行、阳性对照临床研究 

Public title:

The efficacy and safety of Nalbuphine Hydrochloride Injection in the treatment of postoperative pain after day surgery: a multicenter, randomized, parallel, and positive controlled clinical study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

盐酸纳布啡注射液治疗日间手术术后疼痛的有效性和安全性的多中心、随机、平行、阳性对照临床研究 

Scientific title:

The efficacy and safety of Nalbuphine Hydrochloride Injection in the treatment of postoperative pain after day surgery: a multicenter, randomized, parallel, and positive controlled clinical study 

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:

程智刚 

研究负责人:

郭曲练 

Applicant:

Cheng Zhigang 

Study leader:

Guo Qulian 

申请注册联系人电话:

Applicant telephone:

+86 13974962116 

研究负责人电话:

Study leader's telephone:

+86 0731-84327413 

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:

chengzg2004@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

qulianguo@hotmail.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:

湖南省长沙市开福区湘雅路87号 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路87号 

Applicant address:

87 Xiangya Road, Changsha, Hunan, China 

Study leader's address:

87 Xiangya Road, Changsha, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

410008 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中南大学湘雅医院 

Applicant's institution:

Xiangya Hospital, Central South 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:

201608066 

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:

中南大学湘雅医院医学伦理委员会 

Name of the ethic committee:

Ethic Committee of the Xiangya Hospital of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-23 

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:

中南大学湘雅医院 

Primary sponsor:

Xiangya Hospital, Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区湘雅路87号 

Primary sponsor's address:

87 Xiangya Road, Changsha, Hunan, 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):

湖北

市(区县):

宜昌

Country:

China

Province:

Hubei

City:

Yichang

单位(医院):

宜昌人福药业有限责任公司

具体地址:

湖北省宜昌开发区大连路19号

Institution
hospital:

Yichang humanwell pharmaceutical ., LTD

Address:

19 Dalian Road, Yichang Developing Zone, Yichang, Hubei, China

经费或物资来源:

宜昌人福药业有限责任公司 

Source(s) of funding:

Yichang humanwell pharmaceutical ., LTD 

研究疾病:

日间手术术后疼痛 

Target disease:

Pain after day 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:

其它 

Study phase:

N/A 

研究目的:

评价盐酸纳布啡注射液治疗日间手术术后疼痛的有效性和安全性. 

Objectives of Study:

To determine the security and validity of Nalbuphine Hydrochloride Injection in the treatment of postoperative pain after day 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:

年龄 18~65 岁,性别不限; ASA 分级 I 或 II 级;日间手术(乳腺手术(非乳癌根治术)、甲状腺手术、宫腔镜手术、腹腔镜下胆囊切除术,手术时间<2小时)术后疼痛患者; 病人麻醉清醒后,疼痛评分达到视觉模拟评分法>3分;自愿参加并签署了知情同意书; 18≤体重指数( BMI)≤29。 

Inclusion criteria

Aged 18 years to 50 years old, male and female; ASA I-II; breast surgery (non-radical mastectomy), thyroid surgery, hysteroscopic surgery, laparoscopic cholecystectomy, operation time <2 hours) postoperative pain patients; After anesthesia awake, the pain score to achieve visual analogue score> 3 points. ICF was signed. BMI 18 to 29. 

排除标准:

已知对本品中的主药或任何一种辅料过敏者, 阿片类药物过敏史患者;急(慢)性酒精中毒、有神经系统疾病史;慢性疼痛病史;药物成瘾及酗酒;麻痹性肠梗阻;颅内压升高或头部损伤;长期应用阿片类药物史;低血压、甲状腺机能减退、哮喘(避免在发作期使用)、前列腺肥大以及癫痫患者;15 日内服用过单胺氧化酶抑制药物或抗抑郁药物;术前肝、肾功能:丙氨酸氨基转移酶( ALT)、 天冬氨酸氨基转移酶( AST)、 尿素氮( BUN)、 肌酐( Cr) 异常( ALT 和 AST 大于正常值上限 1.5 倍, BUN 和Cr 高于正常值上限);冠心病、支气管哮喘、控制不当或很难控制的高血压:收缩压( SBP) ≥160mmHg 或舒张压( DBP)≥100mmHg;呼吸功能不全,呼吸衰竭;不能正确表达意愿患者;依从性差、不能按研究方案完成试验者;入选前 30 天内参加过其他药物试验;孕妇、产妇、妊娠试验阳性的育龄妇女;凝血功能异常;研究者认为不适宜参加本试验。 

Exclusion criteria:

The patients known to allergy to the main drug or any kind of excipient,or known to allergy to opioids.Acute (slow) alcoholism, a history of neurological diseases. A history of chronic pain. Drug addiction and alcoholism. Paralytic ileus. Increased intracranial pressure or head injury.A history of Long-term use of opioids. Hypotension, hypothyroidism, asthma (avoid use during episodes). Prostatic hypertrophy and epilepsy patients. Taking monoamine oxidase inhibitors or antidepressants in 15 days. Preoperative liver and kidney function: ALT,AST,BUN,Cr abnormalities(ALT and AST greater than 1.5 times the upper limit of normal, BUN and Cr higher than the upper limit of normal).Coronary heart disease, bronchial asthma, poorly controlled or very difficult to control hypertension: SBP≥160mmHg or DBP≥100mmHg. Respiratory insufficiency, respiratory failure.Patients can not properly express wishes. Poor compliance, cant complete the trial according to the study protocol. Participated in the other tries in 30 days.Pregnant women, maternal, pregnancy test positive women of childbearing age.Coagulation dysfunction. The patients whom investigators did not consider appropriate to participate the trial. 

研究实施时间:

Study execute time:

From2016-12-01To 2017-08-01 

征募观察对象时间:

Recruiting time:

From2016-12-01To 2017-08-01 

干预措施:

Interventions:

组别:

试验组

样本量:

250

Group:

experimental group

Sample size:

干预措施:

纳布啡

干预措施代码:

Intervention:

nalbuphine

Intervention code:

组别:

对照组

样本量:

250

Group:

control group

Sample size:

干预措施:

曲马多

干预措施代码:

Intervention:

Tramadol

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅医院 

单位级别:

三甲 

Institution
hospital:

Xiang Ya hospital,Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅三医院 

单位级别:

三甲 

Institution
hospital:

The Third Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Fudan University Shanghai Cancer Center  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第三医院 

单位级别:

三甲 

Institution
hospital:

The Third Affiliated Hospital, Sun Yat-sen University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

湖南省人民医院 

单位级别:

三甲 

Institution
hospital:

Hunan Provincial People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医科大学航空总医院 

单位级别:

三甲 

Institution
hospital:

Aviation General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学首钢医院 

单位级别:

三甲 

Institution
hospital:

Peking University Shougang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京地坛医院 

单位级别:

三甲 

Institution
hospital:

Beijing Ditan Hospital Capital Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

佛山市第一人民医院 

单位级别:

三甲 

Institution
hospital:

The first people's Hospital of Foshan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西医学科学院山西大医院 

单位级别:

三甲 

Institution
hospital:

Shanxi Academy Of Medical Sciences,Shanxi Dayi Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

镇痛有效率

指标类型:

主要指标 

Outcome:

Analgesia effectiveness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸频率

指标类型:

次要指标 

Outcome:

Respiratory rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

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:

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):

由统计软件R产生随机序列

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

Random sequence generated by R.

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):

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):

在中国临床试验注册中心共享

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

sharing in Chinese clinical trial registry

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:

采用excel表进行数据保存和管理。

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

The original data was saved by excel spreadsheet.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-28
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