ChiCTR2400092733 版本V1.0 版本创建时间2024/11/21 23:37:48 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：

ChiCTR2400092733 

最近更新日期：

Date of Last Refreshed on：

2024-11-21 23:37:41 

注册时间：

Date of Registration：

2024-11-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基层医院分娩镇痛DPE联合程控硬膜外间歇脉冲注入技术的推广应用研究

Public title：

A Study on the Promotion and Application of Combined Dural Puncture Epidural Analgesia and Programmed Intermittent Epidural Bolus in Primary Hospitals

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基层医院分娩镇痛DPE联合程控硬膜外间歇脉冲注入技术的推广应用研究

Scientific title：

A Study on the Promotion and Application of Combined Dural Puncture Epidural Analgesia and Programmed Intermittent Epidural Bolus in Primary Hospitals

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：

陈敏 

研究负责人：

陈敏 

Applicant：

Min CHEN 

Study leader：

Min CHEN 

申请注册联系人电话：

Applicant telephone：

+86 578 303 7202

研究负责人电话：

Study leader's telephone：

+86 578 303 7202

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：

83183875@qq.com

研究负责人电子邮件：

Study leader's E-mail：

83183875@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：

浙江省丽水市莲都区寿尔福路7号妇幼保健院麻醉科

研究负责人通讯地址：

浙江省丽水市莲都区寿尔福路7号妇幼保健院麻醉科

Applicant address：

Department of Anesthesiology, Maternal and Child Health Hospital, No. 7 Shouerfu Road, Liandu District, Lishui City, Zhejiang Province, China

Study leader's address：

Department of Anesthesiology, Maternal and Child Health Hospital, No. 7 Shouerfu Road, Liandu District, Lishui City, Zhejiang Province, 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：

丽水市妇幼保健院

Applicant's institution：

Lishui Maternal and Child Health Hospital

研究负责人所在单位：

丽水市妇幼保健院

Affiliation of the Leader：

Lishui Maternal and Child Health Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2410142006366

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：

浙江省丽水市妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Zhejiang Lishui Maternal and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-11-14 00:00:00

伦理委员会联系人：

刘姣

Contact Name of the ethic committee：

Jiao LIU

伦理委员会联系地址：

浙江省丽水市莲都区寿尔福路7号妇幼保健院1号楼科研处

Contact Address of the ethic committee：

Research Department, Building 1, Maternal and Child Health Hospital, No. 7 Shouerfu Road, Liandu District, Lishui City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 139 6709 4098

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：

丽水市妇幼保健院

Primary sponsor：

Lishui Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

浙江省丽水市莲都区寿尔福路7号妇幼保健院麻醉科

Primary sponsor's address：

Department of Anesthesiology, Maternal and Child Health Hospital, No. 7 Shouerfu Road, Liandu District, Lishui City, Zhejiang Province, 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)：

浙江

市(区县)：

Country：

China

Province：

zhejiang

City：

单位(医院)：

丽水市科技局

具体地址：

丽水市灯塔街157号（323000）

Institution
hospital：

Lishui Science and Technology Bureau

Address：

157 Dengta St, Liandu District, Lishui, Zhejiang, China, 323000

经费或物资来源：

申报单位自筹

Source(s) of funding：

Self-financing by the applicant

Target disease：

Labor pain

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

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

本项目旨在深入研究基层医院DPE联合程控硬膜外间歇脉冲注入技术的推广应用，比较其与传统EP或CSE技术联合程控硬膜外间歇脉冲注入技术在分娩镇痛效果及安全性方面的差异。旨在提高丽水地区分娩镇痛的质量和效果，改善产妇体验，降低不良反应发生率，解决丽水地区分娩镇痛普及率低的问题。  

Objectives of Study：

This project aims to conduct a comprehensive study on the promotion and application of DPE combined with programmed epidural intermittent pulse injection technology in primary hospitals. It will compare the differences between this approach and traditional EP or CSE technology, also combined with programmed epidural intermittent pulse injection technology, in terms of labor analgesia effects and safety. The goal is to enhance the quality and efficacy of labor analgesia in the Lishui area, improve the experience of parturients, reduce the incidence of adverse reactions, and address the issue of the low prevalence of labor analgesia in the Lishui region.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①孕周≥37周，初产妇，单胎妊娠； ②计划进行阴道分娩； ③产妇主动要求接受分娩镇痛； ④无椎管内麻醉禁忌。

Inclusion criteria

1. Gestational age of 37 weeks or greater, primiparous, singleton pregnancy. 2. Planned vaginal delivery. 3. Maternal request for labor analgesia. 4. Absence of contraindications to spinal anesthesia.

排除标准：

①胎儿脐带绕颈、胎动异常、羊水异常； ②既往有对分娩镇痛药物过敏史的产妇； ③有出血倾向或凝血功能障碍的产妇； ④有严重精神疾病或认知功能障碍的产妇； ⑤有感染性疾病或其他不宜进行分娩镇痛的情况； ⑥严重心血管、呼吸、神经系统等系统性疾病； ⑦不愿意签署知情同意书的产妇； ⑧其他研究团队认为不适合参与研究的特殊情况。

Exclusion criteria：

1. Fetal cord entanglement, abnormal fetal movements, or amniotic fluid abnormalities. 2. History of allergy to labor analgesic medications in the mother. 3. Maternal bleeding tendencies or coagulopathy. 4. Maternal severe psychiatric disorders or cognitive impairments. 5. Presence of infectious diseases or other contraindications to labor analgesia. 6. Severe systemic diseases affecting the cardiovascular, respiratory, or neurological systems. 7. Maternal refusal to sign the informed consent form. 8. Any other special circumstances deemed inappropriate for study participation by the research team.

研究实施时间：

Study execute time：

从 From 2024-11-25 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-11-25 00:00:00 至 To 2025-09-01 00:00:00  

干预措施：

Interventions：

组别：

连续硬膜外麻醉（EP）联合PIEB技术进行分娩镇痛组（EP组）

样本量：

59

Group：

Continuous epidural analgesia (EP) combined with programmed intermittent epidural bolus (PIEB) for the labor analgesia group (EP group).

Sample size：

干预措施：

连续硬膜外麻醉（EP）组：选择L2-3椎间隙穿刺。18G硬膜外穿刺针穿刺成功后，硬膜外腔注射1.5%利多卡因3ml,置入硬膜外导管，证实无局麻药中毒及全脊麻后硬膜外给予负荷剂量药物（0.1%罗哌卡因+0.2μg/ml舒芬太尼）10ml，1小时后接程控间歇硬膜外脉冲泵背景剂量每小时泵注药物（0.1%罗哌卡因+0.2μg/ml舒芬太尼）10ml，PCEA剂量8ml,锁定时间20min。

干预措施代码：

Intervention：

Continuous Epidural Analgesia (EP) Group: A puncture at the L2-3 intervertebral space was performed using an 18G epidural needle. Following successful placement, 3 ml of 1.5% lidocaine was injected into the epidural space, and an epidural catheter was inserted. After confirming the absence of local anesthetic toxicity and total spinal anesthesia, a loading dose of medication (0.1% ropivacaine + 0.2 μg/ml sufentanil) totaling 10 ml was administered epidurally. After one hour, a programmed intermittent epidural bolus (PIEB) pump was initiated, delivering a background dose of medication (0.1% ropivacaine + 0.2 μg/ml sufentanil) at 10 ml per hour, with a patient-controlled epidural analgesia (PCEA) dose of 8 ml and a lockout interval of 20 minutes.

Intervention code：

组别：

腰硬联合麻醉（CSE）联合PIEB技术进行分娩镇痛组（CSE组）

样本量：

59

Group：

Combined spinal-epidural anesthesia (CSE) with programmed intermittent epidural bolus (PIEB) for the labor analgesia group (CSE group).

Sample size：

干预措施：

腰硬联合麻醉（CSE）组：选择L2-3椎间隙穿刺。18G硬膜外穿刺针穿刺成功后，用25G腰麻细针刺破硬脊膜，见脑脊液流出后，在蛛网膜下隙注射布比卡因2.0mg+舒芬太尼2.5μg，拔除腰麻针，在硬膜外腔注射1.5%利多卡因3ml,置入硬膜外导管，证实无无局麻药中毒及全脊麻，1小时后硬膜外接程控间歇硬膜外脉冲泵背景剂量每小时泵注药物（0.1%罗哌卡因+0.2μg/ml舒芬太尼）10ml，PCEA剂量8ml,锁定时间20min。

干预措施代码：

Intervention：

Combined Spinal-Epidural Anesthesia (CSE) Group: Puncture at the L2-3 intervertebral space was performed using an 18G epidural needle. After successful puncture, a 25G spinal needle was used to penetrate the dura, and upon observing cerebrospinal fluid flow, 2.0 mg of bupivacaine and 2.5 μg of sufentanil were injected into the subarachnoid space. The spinal needle was then removed, and 3 ml of 1.5% lidocaine was injected into the epidural space. Following confirmation of no local anesthetic toxicity and total spinal anesthesia, the same PIEB protocol as the EP group was followed.

Intervention code：

组别：

硬脊膜穿破硬膜外麻醉（DPE）联合PIEB技术进行分娩镇痛组（DPE组）

样本量：

59

Group：

Dural puncture epidural analgesia (DPE) combined with programmed intermittent epidural bolus (PIEB) for the labor analgesia group (DPE group).

Sample size：

干预措施：

硬脊膜穿破硬膜外麻醉（DPE）组：选择L2-3椎间隙穿刺。18G硬膜外穿刺针穿刺成功后，用25G腰麻细针刺破硬脊膜，见脑脊液流出后拔除腰麻针，在硬膜外腔注射1.5%利多卡因3ml,置入硬膜外导管，证实无无局麻药中毒及全脊麻后硬膜外给予负荷剂量药物（0.1%罗哌卡因+0.2μg/ml舒芬太尼）10ml，1小时后接程控间歇硬膜外脉冲泵背景剂量每小时泵注药物（0.1%罗哌卡因+0.2μg/ml舒芬太尼）10ml，PCEA剂量8ml,锁定时间20min。

干预措施代码：

Intervention：

Dural Puncture Epidural Analgesia (DPE) Group: A puncture at the L2-3 intervertebral space was performed with an 18G epidural needle. After successful puncture, a 25G spinal needle was utilized to penetrate the dura, and upon cerebrospinal fluid return, the spinal needle was withdrawn. Subsequently, 3 ml of 1.5% lidocaine was injected into the epidural space. After confirming the absence of local anesthetic toxicity and total spinal anesthesia, a loading dose of medication (0.1% ropivacaine + 0.2 μg/ml sufentanil) totaling 10 ml was administered epidurally. One hour later, the PIEB pump was initiated, delivering a background dose of medication (0.1% ropivacaine + 0.2 μg/ml sufentanil) at 10 ml per hour, with a PCEA dose of 8 ml and a lockout interval of 20 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China 

Province：

zhejiang 

City：

 

单位(医院)：

丽水市妇幼保健院 

单位级别：

三乙 

Institution
hospital：

Lishui Maternal and Child Health Hospital

Level of the institution：

Grade tertiary hospital

测量指标：

Outcomes：

指标中文名：

NRS（数字评分量表）评分≤3分所用时间

指标类型：

主要指标

Outcome：

Time taken for NRS (Numeric Rating Scale) score ≤ 3.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

麻醉药物总用量

指标类型：

次要指标

Outcome：

Total dosage of anesthetic drugs.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

新生儿出生后1min、5min 阿普加评分及脐动脉血气分析

指标类型：

次要指标

Outcome：

Apgar scores at 1 minute and 5 minutes after birth, along with umbilical artery blood gas analysis.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分娩期间恶心呕吐、头痛、皮肤瘙痒、低血压、神经损伤等不良反应发生情况。

指标类型：

副作用指标

Outcome：

Incidence of adverse reactions during labor, including nausea and vomiting, headache, pruritus, hypotension, and neurological injury.

Type：

Adverse events

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：

新生儿脐带血

组织：

Sample Name：

Umbilical cord blood of the neonate.

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 20 岁 years
最大 Max age 40 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）：

由不参与数据收集的护士通过计算机软件随机生成研究序列

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

The study sequence was randomly generated by nurses not involved in data collection using computer software.

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：

双盲法。即在研究过程中，既不让受试者知道他们所属的组别，也不让研究人员（或实施干预的医生）知道参与者的组别。

Blinding：

Double-blind method. In this study, neither the participants nor the researchers (or the physicians administering the intervention) were informed of the participants' group assignments.

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

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）：

2026年12月30日后以邮件索取方式公开，邮箱：83183875@qq.com。

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

Available upon request via email after December 30, 2026, at: 83183875@qq.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：

麻醉监护仪采集数据，电脑记录数据

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

Anesthesia monitor collects data, computer records data

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：

  2024-11-21 23:37:41