ChiCTR2200063690 版本V1.0 版本创建时间2022/09/14 22:34:16 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200063690 

最近更新日期：

Date of Last Refreshed on：

 2022-09-14 22:34:08 

注册时间：

Date of Registration：

 2022-09-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声辅助定位下微创腰麻技术在剖宫产手术中的应用：一项随机平行对照RCT研究

Public title：

Application of minimally ultrasound-assisted spinal anesthesia in cesarean section: a randomized parallel-controlled RCT study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

微创腰麻技术对剖宫产麻醉效果及近远期并发症的影响

Scientific title：

Minimally spinal anesthesia for cesarean section anesthesia effect and short-term and long-term complications

研究课题代号(代码)：

Study subject ID：

 Hwk2021yb017

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：

No

申请注册联系人：

韩博 

研究负责人：

朱海娟 

Applicant：

Bo Han 

Study leader：

Hai-Juan Zhu 

申请注册联系人电话：

Applicant telephone：

 18840185182

研究负责人电话：

Study leader's
telephone：

13966778885

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：

 454379626@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 35880762@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：

安徽省合肥市庐阳区益民街15号安徽省妇幼保健院

研究负责人通讯地址：

安徽省合肥市庐阳区益民街15号安徽省妇幼保健院

Applicant address：

Anhui Maternal and Child Health Care Hospital, No.15 Yimin Street, Luyang District, Hefei City, Anhui Province

Study leader's address：

Anhui Maternal and Child Health Care Hospital, No.15 Yimin Street, Luyang District, Hefei City, Anhui Province

申请注册联系人邮政编码：

Applicant postcode：

 230001

研究负责人邮政编码：

Study leader's postcode：

 230001

申请人所在单位：

安徽省妇幼保健院

Applicant's institution：

Anhui Maternal and Child Health Care Hospital

研究负责人所在单位：

安徽省合肥市庐阳区益民街15号安徽省妇幼保健院

Affiliation of the Leader：

Anhui Maternal and Child Health Care Hospital, No.15 Yimin Street, Luyang District, Hefei City, Anhui 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：

 YYLL2021-jy009-02-01

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：

安徽省妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Anhui Maternal and Child Health Care Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-10-28 00:00:00

伦理委员会联系人：

张彬

Contact Name of the ethic committee：

Bin Zhang

伦理委员会联系地址：

安徽省合肥市益民路15号合肥市妇幼保健院科教部

Contact Address of the ethic committee：

Department of Science and Education of Hefei Maternal and Child Health Hospital, 15 Yimin Road, Hefei, Anhui, 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：

安徽省妇幼保健院

Primary sponsor：

Anhui Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

安徽省妇幼保健院

Primary sponsor's address：

Anhui Maternal and Child Health Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽省

市(区县)：

合肥市

Country：

China

Province：

Anhui province

City：

Hefei city

单位(医院)：

安徽省妇幼保健院

具体地址：

安徽省合肥市庐阳区益民街15号

Institution
hospital：

Anhui Maternal and Child Health Hospital

Address：

No.15 Yimin Street, Luyang District, Hefei City, Anhui Province

经费或物资来源：

合肥市卫生健康应用医学项目（Hwk2021yb017）

Source(s) of funding：

Applied Medical Research Project of Hefei Health and Family Planning Commission (Hwk2021yb017)

研究疾病：

剖宫产  

Target disease：

Cesarean section

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟评价超声辅助定位下MSA技术用于剖宫产手术的临床效果及并发症，为剖宫产的麻醉方式提供更优选择。  

Objectives of Study：

This study was designed to evaluate the clinical effects and complications of ultrasound-guided MSA in cesarean section, so as to provide a better choice of anesthesia for cesarean section.

药物成份或治疗方案详述：

麻醉方法：入室后开放外周静脉通道，监测心电图、无创动脉血压、血氧饱和度、脉率，于术前30min内输注聚明胶肽500ml。麻醉前后产科医生听胎心，确保胎心处于正常范围。三组患者均左侧卧位，由同一名富有临床经验的麻醉医生进行麻醉穿刺操作。A组采用体表标志定位法：两次髂嵴最高点连线与脊柱的交点视为L3-4棘突间隙或第4腰椎。消毒后无需局麻操作，选择L2-3棘突间隙使用25G腰麻穿刺针进行穿刺，待确认脑脊液通畅流出后输注由2ml1%盐酸罗哌卡因（耐乐品）+1ml10%葡萄糖注射液+1ml脑脊液组成的混合液视身高给予2.5-3ml。B组在麻醉实施前使用手持超声设备（Acuto）根据骶骨方向向头侧移动通过计数椎间隙显像确定L2及L3棘突水平，通过超声探头外四方圆环在皮肤上的标记，取其横纵中点连线交点作为穿刺点。通过超声显示皮肤距硬膜外腔距离大致确定腰麻穿刺针的进针深度，做标志后从穿刺点进针实施麻醉操作，麻醉操作方法同A组。C组超声辅助定位操作方式同B组，待确认穿刺点后通过局麻-破皮-硬膜外针穿刺，通过气泡压缩试验确认针在硬膜外腔后使用25G腰麻针穿破硬脊膜实施蛛网膜下腔穿刺，硬膜外腔不追加药物。穿刺成功后记录穿刺次数、穿刺时间、穿刺过程中是否出现异感、进行穿刺VAS评分判定，翻身平卧调整床为头低30度，给予去氧肾上腺素8ug预防仰卧位综合征，并根据血压及心率变化情况进行追加。5min后通过对冰的感觉确认头侧感觉阻滞平面并记录，记录术中因麻醉效果差导致的麻醉方式更改情况及静脉药辅助用量。待胎儿剖出后测定胎儿Apgar评分，术后3天内进行每日随访并记录腰背疼痛及出现神经刺激症状情况。 

Description for medicine or protocol of treatment in detail：

Anesthesia methods: After entering the room, the peripheral venous channel was opened, and the ECG, non-invasive arterial blood pressure, oxygen saturation and pulse rate were monitored. Polygelatin peptide 500ml was infused within 30min before surgery. The obstetricians listened to the fetal heart before and after anesthesia to ensure that the fetal heart was in the normal range. The patients in the three groups were all in the left lateral decubitus position. The anesthesia puncture was performed by the same anesthesiologist with rich clinical experience. In Group A, body surface marker positioning was adopted: The intersection point of the line connecting the highest points of the iliac crests and the spine two times was considered as the L3-4 spinous process space or the fourth lumbar vertebra. After disinfection, no local anesthesia was required. The puncture was performed using a 25G spinal anesthesia needle in the L2-3 spinous process space. After confirming the smooth outflow of cerebrospinal fluid, a mixture consisting of 2ml1% ropivacaine hydrochloride +1ml10% glucose injection +1ml cerebrospinal fluid was infused and 2.5-3ml was given depending on height. In Group B, before anesthesia, the handheld ultrasonic device (Acuto) was used to determine the level of L2 and L3 spinous processes by counting intervertebral space imaging according to the sacrum direction and cephalic movement. The skin was marked by the quadrilateral ring outside the ultrasonic probe, and the intersection point of the line connecting the transverse and longitudinal midpoints was taken as the puncture point. The needle insertion depth of lumbar anesthesia needle was roughly determined by the distance between skin and epidural space shown by ultrasound, and the needle was inserted from the puncture point after marking. The anesthesia operation method was the same as that in Group A. The operation mode of ultrasound-assisted positioning in the group C was the same as that in the group B. After the puncture point was confirmed, the puncture was performed using local anesthesia–skin incision–epidural needle. After the needle was inserted into the epidural space, a 25G spinal anesthesia needle was used to puncture the dura mater for subarachnoid puncture. No additional drugs were added into the epidural space. After successful puncture, the puncture times, puncture time, and whether there was any abnormal sensation during the puncture were recorded, and the VAS score for puncture was determined. After the patient turned over and lay down, the bed was adjusted to be 30 degrees lower than his head. Norepinephrine 8ug was administered to prevent supine syndrome, and additional treatments were performed according to the changes of blood pressure and heart rate. After 5min, the plane of cephalic sensory block was confirmed by the sensation of ice and recorded, together with the changes of anesthesia mode and the auxiliary dosage of intravenous drugs due to poor anesthesia effect during the operation. The Apgar score of the fetus was measured after the fetus was dissected, and daily follow-up was conducted within 3 days after operation, and the low back pain and the occurrence of nerve stimulation symptom were recorded. 

纳入标准：

在安徽省妇幼保健院经规范产检，产科医生询问病史及超声检查确定具有剖宫产手术指征择期拟行子宫下段剖宫产术；ASA I-II级；年龄22-35岁；孕周37-42周。

Inclusion criteria

Inclusion criteria: A cesarean section in the lower uterine segment was planned for at an elective date in Anhui Women's and Children's Health Hospital after standardized antenatal examination, when the obstetrician asked the medical history and ultrasound examination confirmed that the patient had the indications for cesarean section; Asa class i-ii; Age 22-35 years old; Gestational weeks 37-42 weeks.

排除标准：

产妇具有妊娠期并发症、神经系统疾病及椎管内禁忌症患者。

Exclusion criteria：

Exclusion criteria: Pregnant women with complications,neurological diseases and contraindications within the spinal canal were excluded.

研究实施时间：

Study execute time：

从 From 2022-09-14 00:00:00至 To 2023-03-14 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-14 00:00:00 至 To 2022-12-10 00:00:00

干预措施：

Interventions：

组别：

微创腰麻组

样本量：

 65

Group：

Minimally invasive spinal anesthesia

Sample size：

干预措施：

采用25G笔尖式腰麻针直接行腰麻穿刺

干预措施代码：

 MSA

Intervention：

To conduct spinal puncture with 25G White needle directly.

Intervention code：

组别：

超声辅助定位下微创腰麻组

样本量：

 65

Group：

Minimally invasive lumbar anesthesia group with handheld ultrasound assisted positioning

Sample size：

干预措施：

经掌上超声确定腰椎间隙中心点和深度后再行25G腰麻针穿刺

干预措施代码：

 UMA

Intervention：

To conduct spinal puncture with 25G White needle after the position and depth is determined by hand-held ultrasound

Intervention code：

组别：

常规腰麻组

样本量：

 65

Group：

Standard spinal anesthesia

Sample size：

干预措施：

采用传统19G-25G针内针技术穿刺

干预措施代码：

 SA

Intervention：

To conduct spinal puncture with the traditional 19G-25G needle-in-needle technique. Intervention code

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 合肥 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 安徽省妇幼保健院 

单位级别：

 三级甲等专科 

Institution
hospital：

Anhui Provincial Maternal and Child Health Hospital

Level of the institution：

Junior college, Grade A

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 合肥 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 安徽医科大学第三附属医院（合肥市第一人民医院） 

单位级别：

 三级甲等 

Institution
hospital：

The Third Affiliated Hospital of Anhui Medical University (The First People’s Hospital of Hefei) The third class and grade A

Level of the institution：

Junior college, Grade A

测量指标：

Outcomes：

指标中文名：

首次穿刺成功率

指标类型：

主要指标

Outcome：

The success rate of first puncture

Type：

Primary indicator

测量时间点：

麻醉穿刺完成后

测量方法：

计数

Measure time point of outcome：

After completing anesthesia puncture

Measure method：

Count

指标中文名：

穿刺时间

指标类型：

主要指标

Outcome：

Puncture time

Type：

Primary indicator

测量时间点：

麻醉开始进针至拔针

测量方法：

计时

Measure time point of outcome：

Anesthesia begins with needle insertion and ends with needle withdrawal

Measure method：

Timer

指标中文名：

穿刺次数

指标类型：

次要指标

Outcome：

Number of cases of abnormal sensation during puncture

Type：

Secondary indicator

测量时间点：

穿刺过程中

测量方法：

计数

Measure time point of outcome：

During the puncture process

Measure method：

Count

指标中文名：

首次穿刺成功率

指标类型：

主要指标

Outcome：

The success rate of first puncture

Type：

Primary indicator

测量时间点：

麻醉穿刺完成后

测量方法：

计数

Measure time point of outcome：

After completing anesthesia puncture

Measure method：

Count

指标中文名：

穿刺时间

指标类型：

主要指标

Outcome：

Puncture time

Type：

Primary indicator

测量时间点：

麻醉开始进针至拔针

测量方法：

计时

Measure time point of outcome：

Anesthesia begins with needle insertion and ends with needle withdrawal

Measure method：

Timer

指标中文名：

穿刺次数

指标类型：

次要指标

Outcome：

Number of cases of abnormal sensation during puncture

Type：

Secondary indicator

测量时间点：

穿刺过程中

测量方法：

计数

Measure time point of outcome：

During the puncture process

Measure method：

Count

指标中文名：

术后神经刺激症状例数

指标类型：

次要指标

Outcome：

Number of cases of postoperative nerve stimulation symptoms

Type：

Secondary indicator

测量时间点：

术后3天

测量方法：

计数

Measure time point of outcome：

3 days after surgery

Measure method：

Count

指标中文名：

术后腰背疼痛

指标类型：

次要指标

Outcome：

Postoperative lumbar pain

Type：

Secondary indicator

测量时间点：

术后3天内

测量方法：

计数

Measure time point of outcome：

Within 3 days after surgery

Measure method：

Count

指标中文名：

麻醉失败例数

指标类型：

主要指标

Outcome：

Cases of anesthesia failure

Type：

Primary indicator

测量时间点：

手术开始时

测量方法：

计数

Measure time point of outcome：

At the beginning of the operation

Measure method：

Count

指标中文名：

头侧感觉阻滞平面

指标类型：

次要指标

Outcome：

Plane of posterior sensory block

Type：

Secondary indicator

测量时间点：

穿刺后5min后

测量方法：

计数

Measure time point of outcome：

5min after puncture

Measure method：

Count

指标中文名：

Apgar评分

指标类型：

次要指标

Outcome：

Apgar score

Type：

Secondary indicator

测量时间点：

胎儿剖出后

测量方法：

Apgar量表评估

Measure time point of outcome：

Measure time point of outcome： After fetal dissection

Measure method：

Apgar scale assessment

指标中文名：

产妇的穿刺疼痛评分

指标类型：

主要指标

Outcome：

NRS pain score of mater during puncture

Type：

Primary indicator

测量时间点：

穿刺完成后

测量方法：

NRS疼痛评分量表

Measure time point of outcome：

After completing anesthesia puncture

Measure method：

NRS pain rating scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 22 岁 years
最大 Max age 35 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

本试验采用随机平行对照，由数据处理者采用计算机生成的随机数序列将本研究符合纳入标准的受试者简单随机分为三组。

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

In this study, a randomized parallel control trial was conducted.The subjects who met the inclusion criteria in this study were simply randomized into two groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

进行剖宫产手术实施麻醉操作的人员不清楚试验内容；试验数据采集者待麻醉实施后进行相关数据采集及回访；因此受试者，研究者及其他涉及该临床试验的人员及统计人员均不清楚分组情况。

Blinding：

The personnel performing anesthesia operation for cesarean section were not clear about the test contents; The test data gatherers conducted relevant data acquisition and return visit after anesthesia implementation.Therefore, the subject, investigator, and other personnel and statisticians involved in this clinical trial were not aware of the grouping.

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）：

2023-06-31日后，通过百度云网盘https://pan.baidu.com/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)：

After2023-01-31, the original data will be made public through Baidu Cloud Net Disk at http://pan.baidu.com.

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：

病例记录表(Case Record Form, CRF)。

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

Case Record Form, CRF.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-09-14 22:34:08