今天是:2019-08-22 星期四

超声引导下髂腹下、髂腹股沟神经阻滞改良
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注册号:

Registration number:

ChiCTR1900023857 

最近更新日期:

Date of Last Refreshed on:

2019-06-14 

注册时间:

Date of Registration:

2019-06-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

超声引导下髂腹下、髂腹股沟神经阻滞改良 

Public title:

An improvement of ultrasound-guided ilioinguinal/iliohypogastric nerve block: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小儿腹股沟区手术中超声引导下髂腹下、髂腹股沟神经阻滞的改良 

Scientific title:

An improvement of ultrasound-guided ilioinguinal/iliohypogastric nerve block in paediatric inguinal surgery: a randomized controlled trial 

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:

李攀 

研究负责人:

李攀 

Applicant:

Li Pan 

Study leader:

Li Pan 

申请注册联系人电话:

Applicant telephone:

+86 13996368242 

研究负责人电话:

Study leader's telephone:

+86 13996368242 

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:

22539094@163.com 

研究负责人电子邮件:

Study leader's E-mail:

22539094@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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院麻醉科 

Applicant's institution:

Department of Anesthesiology, Children's Hospital of Chongqing 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:

(2019)年伦审(研)第(78)号 

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:

重庆医科大学附属儿童医院伦理委员会 

Name of the ethic committee:

Institutional Review Board, Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-17 

伦理委员会联系人:

袁誉铭 

Contact Name of the ethic committee:

Yuan Yuming 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

Yuzhong District

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

腹股沟疝、鞘膜积液 

Target disease:

Inguinal Hernia and Hydrocele 

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:

以神经阻滞效果为主要研究终点,对超声引导下两种神经阻滞穿刺技术进行比较,并同时从其对患儿生命体征、术后镇痛效果、操作者便利性等方面进行综合评价。研究结果对于进一步优化超声引导下髂腹下、髂腹股沟神经阻滞操作技术,尤其是提高针对腹部凹陷明显者的成功率,降低麻醉风险,提高小儿日间手术安全性等具有积极意义。 

Objectives of Study:

It is compared between these two kinds of ultrasound-guided nerve block techniques, taking the nerve block effect as the main research end point, and the comprehensive evaluation of the vital signs, postoperative analgesia effect and operator convenience will be also carried out. The result of the study will be significant for further optimization of ultrasound-guided ilioinguinal/iliohypogastric nerve block, especially for the success rate on the children whose abdomen are obvious depression, reducing the risk of anesthesia and improving the safety of ambulatory surgery for children. 

药物成份或治疗方案详述:

改良组:将线阵超声探头沿患儿身体横轴方向放置靠近且高于髂嵴水平,后逐渐沿髂骨前缘向内向下移动探头,至靠近髂前上棘的位置,在探头移动过程中注意在腹内斜肌与腹横肌间找寻髂腹下、髂腹沟神经清晰显示平面,并将髂腹下、髂腹沟神经置于屏幕正中,后将超声探头逐渐转向大致沿髂骨走行方向,探头转向过程中始终保持髂腹下、髂腹沟神经置于屏幕正中,阻滞针由探头近心端侧向远心端侧平面内进针,阻滞针尖位于两根神经之间时先回抽无血后少量推注局麻药液以确认针尖位于正确的平面,确认平面后推注局麻药液0.4ml/kg(共计)。 传统组:将线阵超声探头放置于手术侧髂前上棘与脐连线上靠近髂前上棘处,轻轻向头侧或足侧移动探头以确认位于腹内斜肌与腹横肌之间的髂腹下、髂腹沟神经,由内向外采用平面内进针,阻滞针尖位于两根神经之间时先回抽无血后少量推注局麻药液以确认针尖位于正确的平面,确认平面后推注局麻药液0.4ml/kg(共计)。 

Description for medicine or protocol of treatment in detail:

Improved group: The linear ultrasound probe is placed close to and higher than the iliac crest level along the transverse axis of the child's body, then the probe gradually moves inward and downward along the anterior border of the ilium to the position near the anterior superior iliac spine. During the movement, the ilioinguinal/ iliohypogastric nerves will be clearly found between obliquus internus abdominis and transversus abdominis. Place these two nerves in the middle of the ultrasound screen, then gradually turn the ultrasound probe to the direction along the ilium, and keep the nerves in the middle of the ultrasound screen all the time. The needle is inserted in plane from proximal to distal, and the needle tip is located between the two nerves. After the syringe was pumped back without any blood, a small amount of local anesthetic solution was injected to confirm that the needle tip is on the correct plane, and then inject local anesthetic solution 0.4ml/kg (total). Traditional group: The linear ultrasound probe is placed on the connection from the anterior superior iliac spine to navel and near the anterior iliac spines on the side of the surgical, then gently move the probe to the head or foot to confirm the ilioinguinal/iliohypogastric nerves between obliquus internus abdominis and transversus abdominis. The needle is inserted in plane from inside to outside, and the needle tip is located between the two nerves. After the syringe was pumped back without any blood, a small amount of local anesthetic solution was injected to confirm that the needle tip is on the correct plane, and then inject local anesthetic solution 0.4ml/kg (total). 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

拟行单侧腹股沟区疾病(腹股沟疝、鞘膜积液)手术,ASAⅠ、Ⅱ,1-7岁,无系统性疾病,凝血功能正常,肝、肾功能正常。 

Inclusion criteria

Surgery for unilateral inguinal diseases (inguinal hernia, hydrocele), ASA I-II, aged 1-7 years, without systemic diseases, normal coagulation function, normal liver and renal function. 

排除标准:

呼吸系统感染,哮喘、癫痫病史,重要辅助检查结果异常,患儿或监护人拒绝参与,神经阻滞禁忌症(如穿刺区感染或组织结构异常)。 

Exclusion criteria:

Respiratory infection, history of asthma or/and epilepsy, abnormal results of important auxiliary examinations, children or guardians refuse to participate, contraindications of nerve block (such as puncture area infection or abnormal tissue structure). 

研究实施时间:

Study execute time:

From2019-07-01To 2019-12-31 

干预措施:

Interventions:

组别:

改良组

样本量:

50

Group:

Improved group

Sample size:

干预措施:

沿髂骨方向行超声引导下小儿髂腹下、髂腹股沟神经阻滞。

干预措施代码:

IG

Intervention:

Ultrasound-guided ilioinguinal/iliohypogastric nerve block in children along the direction of ilium.

Intervention code:

组别:

传统组

样本量:

50

Group:

Traditional group

Sample size:

干预措施:

沿髂前上棘与脐连线行超声引导下小儿髂腹下、髂腹股沟神经阻滞。

干预措施代码:

TG

Intervention:

Ultrasound-guided ilioinguinal/iliohypogastric nerve block in children along the connection from the anterior superior iliac spine to navel.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong District 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

围术期追加丙泊酚的时点及次数

指标类型:

主要指标 

Outcome:

The time and frequency of adding propofol during the perioperative period

Type:

Primary indicator 

测量时间点:

围术期

测量方法:

出现影响手术进程的体动情况,即予丙泊酚1mg/kg静脉推注。

Measure time point of outcome:

Perioperative period

Measure method:

A 1mg/kg intravenous injection of propofol whenever the body motion affects the procedure of the sugery.

指标中文名:

术后疼痛

指标类型:

主要指标 

Outcome:

Postoperative pain

Type:

Primary indicator 

测量时间点:

术后24小时

测量方法:

电话随访家属

Measure time point of outcome:

24 hours after surgery

Measure method:

Telephone follow-up to family members

指标中文名:

术后并发症

指标类型:

主要指标 

Outcome:

Postoperative complications

Type:

Primary indicator 

测量时间点:

术后24小时

测量方法:

电话随访家属

Measure time point of outcome:

24 hours after surgery

Measure method:

Telephone follow-up to family members

指标中文名:

生命体征

指标类型:

次要指标 

Outcome:

Vital signs

Type:

Secondary indicator 

测量时间点:

围术期

测量方法:

监护仪

Measure time point of outcome:

Perioperative period

Measure method:

Monitor

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 1 years
最大 Max age 7 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):

由非该研究直接参与人员通过SPSS16.0(固定值为20190327)产生随机分组。

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

Random grouping is generated by indirect participant through SPSS16.0 (fixed value is 20190327).

盲法:

双盲 请说明施盲对象。

Blinding:

Double-blind

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):

试验完成后6个月内,在中国临床试验注册中心公开原始数据。

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

Open raw data at the China Clinical Trial Registration Center within 6 months after the trial is completed.

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:

数据采集使用病例记录表格,管理使用Excel表格。

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

Data collection using case record forms, management using Excel forms.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-14
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