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不同脉冲泵给药方案用于分娩镇痛的效果:一项随机对照研究
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注册号:

Registration number:

ChiCTR2000040450 

最近更新日期:

Date of Last Refreshed on:

2021-11-09 

注册时间:

Date of Registration:

2020-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同脉冲泵给药方案用于分娩镇痛的效果:一项随机对照研究 

Public title:

Effect of programmed intermittent epidural bolus at different dosage regimens for labor analgesia: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同脉冲泵给药方案用于分娩镇痛的效果:一项随机对照研究 

Scientific title:

Effect of programmed intermittent epidural bolus at different dosage regimens for labor analgesia: 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:

左荣华 

研究负责人:

王志萍 

Applicant:

Ronghua Zuo 

Study leader:

Zhiping Wang 

申请注册联系人电话:

Applicant telephone:

+86 15505183533 

研究负责人电话:

Study leader's telephone:

+86 13338787071 

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:

zuomaybe@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhpxqst@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

徐州医科大学 

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:

江苏省徐州市淮海西路99号 

研究负责人通讯地址:

江苏省徐州市淮海西路99号 

Applicant address:

99 Huaihai Road West, Xuzhou, Jiangsu, China 

Study leader's address:

99 Huaihai Road West, Xuzhou, Jiangsu, 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:

徐州医科大学 

Applicant's institution:

XuZhou 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:

XYFY2020-KL218-02 

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:

徐州医科大学附属医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Xuzhou Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2021-01-13 

伦理委员会联系人:

翟凤平 

Contact Name of the ethic committee:

Fengping Zhai 

伦理委员会联系地址:

徐州市淮海西路99号 

Contact Address of the ethic committee:

99 Huaihai Road West, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University  

研究实施负责(组长)单位地址:

江苏省徐州市淮海西路99号 

Primary sponsor's address:

99 Huaihai Road West, Xuzhou, Jiangsu, 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):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州医科大学附属医院麻醉科

具体地址:

淮海西路99号

Institution
hospital:

Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University

Address:

99 Huaihai Road West

经费或物资来源:

政府和自筹 

Source(s) of funding:

Government and self-funded 

研究疾病:

分娩镇痛 

Target disease:

labor analgesia 

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:

探索性研究/预试验 

Study phase:

研究目的:

本试验分为两部分进行: 第一部分研究:本研究通过比较脉冲泵在固定脉冲间隔时间不同脉冲量对分娩镇痛过程中爆发痛发生率的影响,寻找临床上对母婴影响最小、镇痛效果好的罗哌卡因剂量; 第二部分研究:探讨第一部分研究得出的较好罗哌卡因剂量在不同PIEB给药间隔下对母婴的安全性,产妇镇痛的有效性及差异性,寻找最佳给药方案。 

Objectives of Study:

The study is divided into two parts: The first part of the study: This study compares the effects of pulse pump at fixed pulse intervals and different pulse doses on the incidence of burst pain during labor analgesia, and seeks for the dose of ropivacaine that has the least clinical impact on mothers and infants and has good analgesic effects. The second part of the study: to explore the safety of the better ropivacaine dose obtained in the first part of the study on the mothers and infants under different PIEB dosing intervals, the effectiveness and difference of maternal analgesia, and to find the best dosing plan. 

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:

1.产妇自愿; 2.ASA II或Ⅲ级; 3.孕周≥37周 ; 4.单胎妊娠,头位先露; 5.NRS评分>5的初产妇; 6.经产科医师评估,可进行阴道分娩试产者(包括瘢痕子宫、妊娠期高血压及子痫前期等)。 

Inclusion criteria

1. Maternal voluntary; 2. ASA I or II; 3. Full term (>=37 weeks gestation); 4. Singleton pregnancy, cephalic vaginal; 5. Nulliparous, NRS Pain score at requesting analgesia >5 (NRS 0-10); 6. Evaluated by obstetricians, vaginal delivery can be carried out (including scar uterus, gestational hypertension and preeclampsia, etc.). 

排除标准:

1.椎管内阻滞禁忌:如颅内高压、凝血功能异常、穿刺部位及全身性感染等,以及影响穿刺操作等情况; 2.意外穿破硬脊膜; 3.局麻药物过敏者; 4.产前2周使用过镇痛、镇静类药物者。  

Exclusion criteria:

1. Any contraindication to epidural anesthesia: such as intracranial hypertension, abnormal blood coagulation, puncture site and systemic infection, as well as affecting the puncture operation; 2. Accidental dural puncture; 3. Allergy or hypersensitivity to bupivacaine or sufentanyl; 4. use of analgesics and sedatives for 2 weeks before delivery. 

研究实施时间:

Study execute time:

From2020-12-01To 2021-12-01 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2021-12-01 

干预措施:

Interventions:

组别:

1组

样本量:

70

Group:

Group 1

Sample size:

干预措施:

程控硬膜外脉冲式注射4ml/45 min

干预措施代码:

Intervention:

programmed intermittent epidural boluses 4ml/45min

Intervention code:

组别:

2组

样本量:

70

Group:

Group 2

Sample size:

干预措施:

程控硬膜外脉冲式注射6ml/45min

干预措施代码:

Intervention:

programmed intermittent epidural boluses 6ml/45min

Intervention code:

组别:

3组

样本量:

70

Group:

Group 3

Sample size:

干预措施:

程控硬膜外脉冲式注射8ml/45min

干预措施代码:

Intervention:

programmed intermittent epidural boluses 8ml/45min

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

爆发痛发生率

指标类型:

主要指标 

Outcome:

incidence of breakthrough pain

Type:

Primary indicator 

测量时间点:

分娩镇痛产程中

测量方法:

Measure time point of outcome:

In the process of labor analgesia

Measure method:

指标中文名:

NRS疼痛评分

指标类型:

次要指标 

Outcome:

NRS pain scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动阻滞发生率

指标类型:

次要指标 

Outcome:

Incidence of motor block

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

分娩镇痛过程中每小时罗哌卡因的消耗量

指标类型:

次要指标 

Outcome:

consumption of ropivacaine per hour during labor analgesia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次PCA的时间

指标类型:

次要指标 

Outcome:

Time of the first PCA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第一产程和第二产程时间

指标类型:

次要指标 

Outcome:

The time of the first stage of labor and the second stage of labor

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:

脐动脉血气

组织:

Sample Name:

umbilical artery blood gas

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 years
最大 Max age 45 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):

采用计算机产生随机序列。

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

Generated random number sequence by computer

盲法:

未说明

Blinding:

Not stated

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):

在试验结束之后可通过作者获取

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

Contact the author of the first after the article is published

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:

各医院病历系统及数据采集自制量表,SPSS25.0进行数据管理。

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

Hospital medical records systems and data collection self-made scale, SPSS26.0 for data management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-28
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