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赵漾医师:请上传研究计划书、知情同意书模板。 术后双侧后侧入路腹横肌平面阻滞联结直肠癌术后镇痛的应用
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注册号:

Registration number:

ChiCTR-IPR-17012650 

最近更新日期:

Date of Last Refreshed on:

2020-11-30 

注册时间:

Date of Registration:

2017-09-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

赵漾医师:请上传研究计划书、知情同意书模板。 术后双侧后侧入路腹横肌平面阻滞联结直肠癌术后镇痛的应用 

Public title:

The analgesic efficacy of post-operative bilateral, ultrasound-guided, posterior transversus abdominis plane block for laparoscopic colorectal cancer surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术后双侧后侧入路腹横肌平面阻滞联结直肠癌术后镇痛的应用 

Scientific title:

The analgesic efficacy of post-operative bilateral, ultrasound-guided, posterior transversus abdominis plane block for laparoscopic colorectal cancer 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:

赵漾 

研究负责人:

赵漾 

Applicant:

Zhao Yang 

Study leader:

Zhao Yang 

申请注册联系人电话:

Applicant telephone:

+86 18281760941 

研究负责人电话:

Study leader's telephone:

+86 18281760941 

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:

594624370@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

594624370@qq.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:

中国四川省南充市顺庆区文化路63号麻醉科 

研究负责人通讯地址:

中国四川省南充市顺庆区文化路63号麻醉科 

Applicant address:

63 Wenhua Road, Shunqing District, Nanchong, Sichuan, China 

Study leader's address:

63 Wenhua Road, Shunqing District, Nanchong, Sichuan, China 

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:

川北医学院附属医院 

Applicant's institution:

Affiliated hospital of North Sichuan Medical College 

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:

2017ER(R)049 

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:

川北医学院附属医院科技部 

Name of the ethic committee:

Affiliated Hospital of North Sichuan Medical College, Ministry of science and technology  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-05 

伦理委员会联系人:

黄洁美 

Contact Name of the ethic committee:

Huang Jiemei 

伦理委员会联系地址:

四川省南充市文化路63号 

Contact Address of the ethic committee:

63 Wenhua Road, Nanchong, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 817 2262124 

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:

川北医学院附属医院 

Primary sponsor:

Affiliated hospital of North Sichuan Medical College 

研究实施负责(组长)单位地址:

中国四川省南充市顺庆区文化路63号 

Primary sponsor's address:

63 Wenhua Road, Shunqing District, Nanchong, Sichuan, 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):

四川

市(区县):

南充

Country:

China

Province:

Sichuan

City:

Nanchong

单位(医院):

川北医学院附属医院

具体地址:

顺庆区文化路63号

Institution
hospital:

Affiliated hospital of North Sichuan Medical College

Address:

63 Wenhua Road, Shunqing District

经费或物资来源:

研究生经费 

Source(s) of funding:

self-raised 

研究疾病:

结直肠癌 

Target disease:

colorectal 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:

上市后药物 

Study phase:

研究目的:

观察术后进行双侧后侧入路腹横筋膜阻滞(0.5%罗哌卡因,20ml每一侧),是否能有效减轻腔镜结直肠癌患者术后的疼痛,减少术后曲马多补救药物的使用,加快患者康复。 

Objectives of Study:

This study aimed to observe whether a post-operative bilateral, ultrasound-guided, posterior transversus abdominis plane block offers more benefits than placebo for patients who underwent elective laparoscopic colorectal cancer surgery in the enhanced recovery after surgery (ERAS) program. 

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:

18-65岁; ASA I-III级;可以清楚表达疼痛择期行腹腔镜结直肠癌根治术的患者 

Inclusion criteria

Aged 18-65yr; ASA I-III; able to express pain; undergoing elective laparoscopic colorectal cancer surgery 

排除标准:

出院前再次接受其他任何手术;局部麻醉药或阿片类药物过敏反应史;体重小于45公斤(以降低麻醉毒性风险);最近阿片类药物接触史;BMI≥30kg/m2;手术前24小时接受疼痛药物治疗;无法使用患者控制的静脉镇痛;需要进行会阴切口切除的患者。 

Exclusion criteria:

receive any surgery again after the elective laparoscopic colorectal cancer surgery until discharged; history of allergic reaction to local anesthetics or opioids; weighed less than 45 kg (to reduce the risk of anaesthetic toxicity); history of recent opioids exposure; BMI >= 30kg/m2; exposure to pain medication 24 hours before surgery; inability to use patient-controlled intravenous analgesiapatients who were to undergo resections requiring perineal incisions. 

研究实施时间:

Study execute time:

From2017-09-12To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2017-09-12To 2018-12-31 

干预措施:

Interventions:

组别:

TAP组

样本量:

46

Group:

group TAP

Sample size:

干预措施:

后侧入路腹横肌平面阻滞

干预措施代码:

Intervention:

transversus abdominis plane block

Intervention code:

组别:

对照组

样本量:

46

Group:

group control

Sample size:

干预措施:

安慰剂对照

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

南充 

Country:

China 

Province:

Sichuan 

City:

Nanchong 

单位(医院):

川北医学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated hospital of North Sichuan Medical College  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

术后24h曲马多使用量

指标类型:

主要指标 

Outcome:

the cumulative consumption of rescue tramadol usage within 24 hours after surgery

Type:

Primary indicator 

测量时间点:

术后24小时

测量方法:

曲马多用量

Measure time point of outcome:

24 hours after surgery

Measure method:

cumulative consumption of rescue tramadol

指标中文名:

术后休息及运动NRS评分

指标类型:

次要指标 

Outcome:

Postoperative resting and moving NRS scores

Type:

Secondary indicator 

测量时间点:

2,4,6,12,24,48,72小时

测量方法:

NRS评分

Measure time point of outcome:

2, 4, 6, 12, 24, 48, 72 hours after surgery

Measure method:

NRS score

指标中文名:

第一次补救镇痛药物的时间

指标类型:

次要指标 

Outcome:

time to first requirement of rescue tramadol muscular injection

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后镇痛满意度

指标类型:

次要指标 

Outcome:

patients’ satisfaction on postoperative analgesia

Type:

Secondary indicator 

测量时间点:

24,48,72小时

测量方法:

1分:非常不满意;2分:不满意;3分:一般;4分:满意;5分:非常满意

Measure time point of outcome:

24, 48, 72 hours

Measure method:

1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied

指标中文名:

排气时间

指标类型:

次要指标 

Outcome:

time to return of intestinal function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下床时间

指标类型:

次要指标 

Outcome:

time to first mobilization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

length of hospital stay (number of nights spent in the hospital from the date of surgery to the date of discharge)

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:

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:

结束

Completed

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):

由韩怡用spss分组产生随机序列 随机种子20170904

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

randomization by Han Yi using SPSS , the random seed was 20170904

盲法:

未说明

Blinding:

Not stated

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

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):

2018年12月通过ResMan共享www.medresman.org.cn

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

IPD will be public accessable via ResMan from Dec 2018 (www.medresman.org.cn)

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:

excel文档管理

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

Excel document management

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-09-12
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