ChiCTR2500108053 版本V1.1 版本创建时间2025/08/28 17:24:26 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：

 ChiCTR2500108053 

最近更新日期：

Date of Last Refreshed on：

 2025-08-25 08:27:10 

注册时间：

Date of Registration：

 2025-08-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

研究连续硬膜外分娩镇痛与腰硬联合分娩镇痛对产妇产程，产时发热，分娩结局的影响

Public title：

Investigate the effects of continuous epidural labor analgesia and combined spinal-epidural labor analgesia on the labor process, intrapartum fever, and delivery outcomes in parturients.

注册题目简写：

连续硬膜外与腰硬联合分娩镇痛对产妇分娩结局的影响

English Acronym：

The Impact of Continuous Epidural Analgesia and Combined Spinal-Epidural Analgesia on Maternal Delivery Outcomes

研究课题的正式科学名称：

研究连续硬膜外分娩镇痛与腰硬联合分娩镇痛对产妇产程，产时发热，分娩结局的影响

Scientific title：

Investigate the effects of continuous epidural labor analgesia and combined spinal-epidural labor analgesia on the labor process, intrapartum fever, and delivery outcomes in parturients.

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：

姚冉薇 

研究负责人：

吴秀玲 

Applicant：

Yao Ranwei 

Study leader：

Wu Xiuling 

申请注册联系人电话：

Applicant telephone：

 +86 158 7585 4784

研究负责人电话：

Study leader's
telephone：

+86 199 0993 7220

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：

 1318874302@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 838957403@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：

新疆石河子人民医院

研究负责人通讯地址：

新疆石河子市人民医院

Applicant address：

Xinjiang Shihezi People's Hospital

Study leader's address：

Xinjiang Shihezi People's Hospital

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：

新疆石河子市人民医院麻醉与围术期医学科

Applicant's institution：

Department of Anesthesiology and Perioperative Medicine, Shihezi People's Hospital, Xinjiang

研究负责人所在单位：

新疆石河子市人民医院麻醉与围术期医学科

Affiliation of the Leader：

Department of Anesthesiology and Perioperative Medicine, Shihezi People's Hospital, Xinjiang

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：

 KYLI-2025-70

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：

石河子市人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shihezi People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-11 00:00:00

伦理委员会联系人：

于海波

Contact Name of the ethic committee：

Yu Haibo

伦理委员会联系地址：

新疆石河子市人民医院

Contact Address of the ethic committee：

Xinjiang Shihezi People's Hospital

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 186 9076 5225

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：

新疆石河子市人民医院

Primary sponsor：

Xinjiang Shihezi People's Hospital

研究实施负责（组长）单位地址：

新疆石河子市人民医院麻醉与围术期医学科

Primary sponsor's address：

Department of Anesthesiology and Perioperative Medicine, Shihezi People's Hospital, Xinjiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新疆

市(区县)：

石河子

Country：

China

Province：

Xinjiang

City：

Shihezi

单位(医院)：

石河子市人民医院

具体地址：

新疆石河子市人民医院麻醉与围术期医学科

Institution
hospital：

Shihezi People's Hospital

Address：

Department of Anesthesiology and Perioperative Medicine, Shihezi People's Hospital, Xinjiang

经费或物资来源：

自费

Source(s) of funding：

Self-funded

研究疾病：

分娩疼痛  

Target disease：

Labor pain

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价连续硬膜外分娩镇痛与腰硬联合分娩镇痛对产妇产程，产时发热，分娩结局的影响。  

Objectives of Study：

Evaluate the effects of continuous epidural labor analgesia and combined spinal-epidural labor analgesia on the labor process, intrapartum fever, and delivery outcomes in parturients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

符合《中国分娩镇痛专家共识》标准：年龄≥18岁的健康初产妇，单胎头位，孕周在37～42周之间；宫口扩张在1～5cm；产妇要求且自愿接受分娩镇痛并签署知情同意书；无椎管内操作相关禁忌症；基础体温≤37.5℃。

Inclusion criteria

Meeting the criteria of the Chinese Expert Consensus on Labor Analgesia: Healthy primiparous women aged ≥18 years, with a singleton fetus in cephalic presentation, at gestational weeks 37–42; cervical dilation between 1–5 cm; the parturient requests and voluntarily agrees to receive labor analgesia and signs an informed consent form; no contraindications related to neuraxial procedures; and a baseline body temperature ≤37.5°C.

排除标准：

ASA＞II级；术前腋窝温度>37.4℃，胎心异常；高风险产妇（子痫前期、前置胎盘、胎儿发育异常）有严重系统性并发症疾；心动过缓；分娩镇痛后2小时内行剖宫产，试产失败；行腰硬联合镇痛后感觉阻滞平面未达到T10或VAS＞3分超过20分钟；硬膜外镇痛禁忌症，剖宫产或者引产的患者均不包括在本研究中。

Exclusion criteria：

ASA physical status > Class II; preoperative axillary temperature > 37.4°C, abnormal fetal heart rate; high-risk parturients (including preeclampsia, placenta previa, or fetal developmental abnormalities) with severe systemic complications; bradycardia; cesarean section performed within 2 hours after labor analgesia, failed trial of labor; after combined spinal-epidural analgesia, the sensory block level did not reach T10 or VAS > 3 for more than 20 minutes; patients with contraindications to epidural analgesia, as well as those undergoing cesarean section or induction of labor, were excluded from this study.

研究实施时间：

Study execute time：

从 From 2025-08-11 00:00:00至 To 2026-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-25 00:00:00 至 To 2026-09-01 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 300

Group：

A Group

Sample size：

干预措施：

在L2-3间隙进行硬膜外穿刺操作，硬膜外导管向头端置入5cm,并固定，通过硬膜外导管给予3ml 2%利多卡因试验剂量，以确定导管在硬膜外腔而非进入血管或者蛛网膜下腔；5分钟后从硬膜外导管连接止痛泵，持续镇痛配方：0.08%罗派卡因+0.5ug/ml舒芬太尼+0.9%氯化钠总量100ml使用程序性间歇性硬膜外泵，设置如下，脉冲剂量是6-8ml/2min泵完，间隔60min，患者自控按键2ml/次，锁时20min。开启镇痛泵，20分钟后，评估患者，产妇可以感觉到规律宫缩且感觉平面阻滞在T10平面，VAS评分<3分，认为镇痛有效。如果在分娩镇痛过程中VAS评分>3分，感觉阻滞平面在T10以下，则指示产妇自己追加镇痛药物，当进展不足时，静脉滴注缩宫素以增加子宫收缩。连续监测胎儿心率。当宫颈扩张到10cm且将进行第二产程时，均停止给药。由熟练地助产士在潜伏期间隔2小时，活跃期间隔1小时评估宫颈扩张的进程

干预措施代码：

Intervention：

The epidural puncture was performed at the L2-3 interspace. The epidural catheter was advanced 5 cm cephalad and secured. A test dose of 3 ml of 2% lidocaine was administered through the epidural catheter to confirm that the catheter was in the epidural space and not in a blood vessel or the subarachnoid space. Five minutes later, the epidural catheter was connected to a patient-controlled analgesia (PCA) pump for continuous analgesia. The analgesic solution consisted of 0.08% ropivacaine + 0.5 μg/ml sufentanil + 0.9% sodium chloride, with a total volume of 100 ml. A programmed intermittent epidural bolus (PIEB) regimen was used, with the following settings: bolus dose of 6–8 ml delivered over 2 minutes, followed by a lockout interval of 60 minutes; patient-controlled bolus dose of 2 ml per activation, with a lockout time of 20 minutes. Twenty minutes after initiating the analgesia pump, the patient was assessed. The parturient could feel regular uterine contractions, and the sensory block level was at the T10 dermatome, with a VAS score <3, indicating effective analgesia. If, during labor analgesia, the VAS score exceeded 3 or the sensory block level dropped below T10, the parturient was instructed to administer additional analgesic medication via the PCA pump. In cases of inadequate labor progression, oxytocin was administered intravenously to enhance uterine contractions. Continuous fetal heart rate monitoring was maintained throughout. When cervical dilation reached 10 cm and the second stage of labor was about to commence, medication administration was discontinued. A skilled midwife assessed cervical dilation every 2 hours during the latent phase and every hour during the active phase.

Intervention code：

组别：

B组

样本量：

 300

Group：

B Group

Sample size：

干预措施：

在L2-3间隙进行硬膜外穿刺操作并采用针内针技术进行腰麻穿刺给于2mg 罗派卡因+0.5 ug舒芬太尼+脑脊液3 ml缓慢注入蛛网膜下腔，随后在硬膜外穿刺针内置入多孔硬膜外导管，置管深度：5cm持续镇痛配方：0.08%罗派卡因+0.5ug/ml舒芬太尼+0.9%氯化钠总量100ml，5分钟后从硬膜外导管连接止痛泵，使用程序性间歇性硬膜外泵，设置如下，脉冲剂量是6-8ml/2min泵完，间隔60min，患者自控按键2ml/次，锁时20min。开启镇痛泵，20分钟后，评估患者，产妇可以感觉到规律宫缩且感觉平面阻滞在T10平面，VAS评分<3分，认为镇痛有效。如果在分娩镇痛过程中VAS评分>3分，感觉阻滞平面在T10以下，则指示产妇自己追加镇痛药物，当进展不足时，静脉滴注缩宫素以增加子宫收缩。连续监测胎儿心率。当宫颈扩张到10cm且将进行第二产程时，均停止给药。由熟练地助产士在潜伏期间隔2小时，活跃期间隔1小时评估宫颈扩张的进程。

干预措施代码：

Intervention：

The epidural puncture was performed at the L2-3 interspace using the needle-through-needle technique for spinal anesthesia. A total of 2 mg ropivacaine + 0.5 μg sufentanil + 3 ml cerebrospinal fluid was slowly injected into the subarachnoid space. Subsequently, a multi-orifice epidural catheter was inserted through the epidural needle to a depth of 5 cm. The continuous analgesia regimen consisted of: 0.08% ropivacaine + 0.5 μg/ml sufentanil + 0.9% sodium chloride, with a total volume of 100 ml. Five minutes after catheter placement, the epidural catheter was connected to a patient-controlled analgesia (PCA) pump using programmed intermittent epidural bolus (PIEB) mode with the following settings: Bolus dose: 6–8 ml over 2 minutes Lockout interval: 60 minutes Patient-controlled bolus: 2 ml per press Lockout time: 20 minutes Twenty minutes after initiating the analgesia pump, the patient was assessed. The parturient could feel regular uterine contractions, with sensory block at the T10 level and a VAS score <3, indicating effective analgesia. If, during labor analgesia, the VAS score exceeded 3 or the sensory block was below the T10 level, the parturient was instructed to self-administer additional analgesic medication. If labor progression was insufficient, oxytocin was administered intravenously to enhance uterine contractions. Continuous fetal heart rate monitoring was maintained. Medication administration was discontinued when cervical dilation reached 10 cm and the second stage of labor commenced. A skilled midwife assessed cervical dilation every 2 hours during the latent phase and every hour during the active phase.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆 

市(区县)：

 石河子 

Country：

China

Province：

Xinjiang

City：

Shihezi

单位(医院)：

 新疆石河子市妇幼保健院 

单位级别：

 二级 

Institution
hospital：

Xinjiang Shihezi Maternal and Child Health Hospital

Level of the institution：

Secondary

国家：

 中国

省(直辖市)：

 新疆 

市(区县)：

 石河子 

Country：

China

Province：

Xinjiang

City：

Shihezi

单位(医院)：

 新疆石河子市人民医院 

单位级别：

 三甲 

Institution
hospital：

Xinjiang Shihezi People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体温

指标类型：

主要指标

Outcome：

body temperature

Type：

Primary indicator

测量时间点：

产前，产时，产后

测量方法：

水银温度计测量腋下温度

Measure time point of outcome：

prenatal,intrapartum,postpartum

Measure method：

Measuring armpit temperature with a mercury thermometer.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

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 18 岁 years
最大 Max age 42 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）：

由麻醉护士使用随机数字表法产生随机序列

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

The random sequence was generated by the nurse anesthetist using a random number table method.

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：

开放标签

Blinding：

Open label

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

否No

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）：

无

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

None

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

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

Case Record Form

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：

  2025-08-25 08:27:04