ChiCTR2300077158 版本V1.0 版本创建时间2023/11/01 08:49:55 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：

 ChiCTR2300077158 

最近更新日期：

Date of Last Refreshed on：

 2023-11-01 08:48:07 

注册时间：

Date of Registration：

 2023-11-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

硬膜外注射地塞米松与静脉注射地塞米松对剖宫产术后镇痛的影响 ---单中心、随机、双盲、安慰剂对照研究

Public title：

Effects of epidural dexamethasone versus intravenous dexamethasone on post-cesarean analgesia --- a single-center, randomized, double-blind, placebo-controlled study

注册题目简写：

硬膜外注射地塞米松与静脉注射地塞米松对剖宫产术后镇痛的影响

English Acronym：

Effects of epidural dexamethasone versus intravenous dexamethasone on post-cesarean analgesia

研究课题的正式科学名称：

硬膜外注射地塞米松与静脉注射地塞米松对剖宫产术后硬膜外自控镇痛的影响 ---单中心、随机、双盲、安慰剂对照研究

Scientific title：

The effects of epidural dexamethasone and intravenous dexamethasone on postoperative patient-controlled epidural analgesia after cesarean section: a single center, randomized, double-blind, placebo-controlled study

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：

崔凯迪 

研究负责人：

崔凯迪 

Applicant：

Kaidi Cui 

Study leader：

Kaidi Cui 

申请注册联系人电话：

Applicant telephone：

 +86 186 8185 6170

研究负责人电话：

Study leader's
telephone：

+86 186 8185 6170

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：

 843095204@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 843095204@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：

陕西省西安市曲江新区雁翔路1616号

研究负责人通讯地址：

陕西省西安市曲江新区雁翔路1616号

Applicant address：

No.1616, Yanxiang Road, Qujiang New District, Xi'an city, Shaanxi Province

Study leader's address：

No.1616, Yanxiang Road, Qujiang New District, Xi'an city, Shaanxi Province

申请注册联系人邮政编码：

Applicant postcode：

 710061

研究负责人邮政编码：

Study leader's postcode：

 710061

申请人所在单位：

西北妇女儿童医院

Applicant's institution：

Northwest Women's and Children's Hospital

研究负责人所在单位：

西北妇女儿童医院

Affiliation of the Leader：

Northwest Women's and Children's Hospital

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：

 2023-060

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：

西北妇女儿童医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of Northwest Women's and Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-09-27 00:00:00

伦理委员会联系人：

姜涛

Contact Name of the ethic committee：

Tao Jiang

伦理委员会联系地址：

陕西省西安市曲江新区雁翔路1616号

Contact Address of the ethic committee：

No.1616, Yanxiang Road, Qujiang New District, Xi'an city, Shaanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 29 8955 0184

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 843095204@qq.com

研究实施负责（组长）单位：

西北妇女儿童医院

Primary sponsor：

Northwest Women's and Children's Hospital

研究实施负责（组长）单位地址：

陕西省西安市曲江新区雁翔路1616号

Primary sponsor's address：

No.1616, Yanxiang Road, Qujiang New District, Xi'an city, Shaanxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

西安市

Country：

China

Province：

Shaanxi Province

City：

Xi'an city

单位(医院)：

西北妇女儿童医院

具体地址：

陕西省西安市曲江新区雁翔路1616号

Institution
hospital：

Northwest Women's and Children's Hospital

Address：

No.1616, Yanxiang Road, Qujiang New District, Xi'an city, Shaanxi Province

经费或物资来源：

自筹经费

Source(s) of funding：

self-provided funds

研究疾病：

剖宫产术后镇痛  

Target disease：

post-cesarean 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：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟通过单中心、随机、双盲、安慰剂对照临床研究，比较地塞米松静脉和硬膜外两种不同给药途径对剖宫产术后硬膜外镇痛效果和不良反应的影响，旨在寻求一种对剖宫产患者更为有效安全的术后镇痛方案。  

Objectives of Study：

This study intends to use a single-center, randomized, placebo-controlled clinical study to further clarify that dexamethasone, as an adjuvant drug for post-cesarean analgesia, can effectively enhance post-operative analgesic effect and reduce post-operative nausea, vomiting, headache and pain. The incidence of postoperative neurological complications enables patients to obtain a better medical experience, restore the self-care ability of the life faster, and ensure the health of mothers and babies. Epidural dexamethasone versus intravenous dexamethasone on post-cesarean analgesia , which one is more effective and safe postoperative analgesia regimen for patients undergoing cesarean section.

药物成份或治疗方案详述：

术前对患者进行评估，一旦患者入选，分配随机号。统计记录患者包括年龄、体重、身高、妊娠次数和胎次等基本信息。术前休息时的基线疼痛评分使用数字评定量表（NRS）对静息和运动时疼痛进行评估（0 表示“没有”疼痛”，10 是“最严重的疼痛”）。参与者被随机分配到三个组。将随机号告知一名未参与试验的未盲的护士，护士在试验日根据随机号为参与者准备两种药物，将4ml(4mg)地塞米松磷酸钠或者4ml0.9%NaCl备在两支同样的5ml的注射器中，并标注好静脉用试验药或者硬膜外用试验药，将两种药物交给负责麻醉的医生，负责麻醉的医生对患者分组并不知情。患者入室后连接标准监护，监测心率、无创血压、血氧饱和度和心电图。所有患者在接受椎管内麻醉操作之前均接受快速静脉输注复方氯化钠10ml/Kg。麻醉技术已标准化，采用左侧卧位实施椎管内麻醉，穿刺间隙选择L3-4，使用2%利多卡因5ml局麻用，0.75%罗哌卡因1.7ml蛛网膜下腔注射，之后在硬膜外放置导管用胶布固定好后患者翻身平躺。测量麻醉平面到T6，麻醉效果良好，即可开始手术。术中泵注去氧肾上腺素输注以维持收缩压在术前基线值的20% 以内。术中出现恶心呕吐时静脉注射昂丹司琼4mg进行治疗。在胎儿娩出后，分别给与静脉研究药和硬膜外研究药物4ml。手术结束后在硬膜外给与吗啡1mg,然后连接硬膜外镇痛泵。镇痛泵的配方采用标准化配方:300mg(30ml)罗哌卡因加5mg吗啡加生理盐水共150ml。镇痛泵参数设置为:背景剂量2ml/h，一次PCA剂量1ml，锁定时间15min。镇痛泵选择爱朋脉冲镇痛泵。 

Description for medicine or protocol of treatment in detail：

Patients were assessed preoperatively, and once enrolled, a random number was assigned. Statistical records of patients include basic information such as age, weight, height, number of pregnancies, and parity. Baseline pain scores at rest before surgery were assessed using the Numeric Rating Scale (NRS) for pain at rest and during movement (0 being no pain and 10 being worst pain). Participants were randomly assigned to Three groups. The random number was informed to an unblinded nurse who did not participate in the study, and the nurse prepared two drugs for the participants on the test day according to the random number, 4ml (4mg) dexamethasone or 4ml 0.9% NaCl were Prepared in two identical 5ml syringes, and mark the test drug for intravenous use or test drug for epidural use, and give the two drugs to the doctor in charge of anesthesia, who is not aware of the group of patients. The patient enters the operating room , Standard monitoring was used throughout the procedure, including non-invasive arterial blood pressure, electrocardiogram (five leads), and pulse oximetry. All patients received rapid intravenous infusion of compound sodium chloride 10ml/Kg before receiving spinal anesthesia. The anesthesia technique has been standardized and the left side Perform intraspinal anesthesia in the supine position, select L3-4 as the puncture space, use 5ml of 2% lidocaine for local anesthesia, inject 1.7ml of 0.75% ropivacaine into the subarachnoid space, and then place it in the epidural. After the catheter was fixed with adhesive tape, the patient turned over and lay flat. The anesthesia plane was measured above T6, and the operation could begin if the anesthesia effect was good. During the operation, phenylephrine was pumped and infused to maintain the systolic blood pressure within 20% of the preoperative baseline value. When nausea and vomiting occurred during the operation, intravenous injection of ondansetron 4mg was used for treatment. After the fetus was delivered, intravenous study drug and epidural study drug 4ml were given respectively. After the operation, 1 mg of morphine was given epidurally, and then the epidural was connected. Extra-membranous analgesic pump. The prescription of analgesic pump adopts standardized formula: 300mg (30ml) ropivacaine adds 5mg morphine and adds normal saline to 150ml.Analgesic pump parameter is set as: background dose 2ml/h, once PCA dose 1ml, The lock time is 15 minutes. The analgesic pump is Apon pulse analgesic pump(FSQ-IV).  

纳入标准：

1、ASA 1~2级 2、年龄 ≥18岁； 3、体重指数在18~30之间； 4、孕周≥37周； 5、拟择期在蛛网膜下-硬膜外麻醉下实施子宫下段剖宫产术； 6、自愿加入研究，并签署知情同意书。

Inclusion criteria

1. ASA level 1-2; 2. Age ≥ 18 years old; 3. Body mass index between 18 and 30; 4. Gestational week ≥ 37 weeks; 5. Plan to electively perform lower uterine segment cesarean section under subarachnoid-epidural anesthesia; 6. Voluntarily participate in the research and sign the informed consent form.

排除标准：

1、对研究药物过敏者； 2、未受控制高血压； 3、存在蛛网膜下-硬膜外麻醉禁忌症； 4、酗酒或药物滥用史； 5、14天内使用过糖皮质激素； 6、4周内摄入处方止痛药； 7、48小时内摄入非处方止痛药； 8、未受控制的糖尿病。

Exclusion criteria：

1. Those who are allergic to the study drug; 2. Uncontrolled hypertension; 3. There are contraindications for subarachnoid-epidural anesthesia; 4. History of alcohol or drug abuse; 5. Glucocorticoids have been used within 14 days; 6. Take prescription painkillers within 4 weeks; 7. Take over-the-counter pain relievers within 48 hours; 8.uncontrolled diabetes.

研究实施时间：

Study execute time：

从 From 2023-11-01 00:00:00至 To 2024-09-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-01 00:00:00 至 To 2024-08-01 00:00:00

干预措施：

Interventions：

组别：

A组:硬膜外地塞米松组

样本量：

 80

Group：

Group A :epidural dexamethasone group

Sample size：

干预措施：

静脉注射4ml0.9%NaCl，硬膜外注射4ml(4mg)地塞米松磷酸钠

干预措施代码：

 A

Intervention：

intravenous injection of 4ml 0.9% NaCl, epidural injection of 4ml (4mg) dexamethasone

Intervention code：

组别：

B组:静脉地塞米松组

样本量：

 80

Group：

Group B : intravenous dexamethasone group

Sample size：

干预措施：

静脉注射4ml(4mg)地塞米松磷酸钠，硬膜外注射4ml0.9%NaCl

干预措施代码：

 B

Intervention：

intravenous injection of 4ml (4mg) dexamethasone, epidural injection of 4ml 0.9% NaCl

Intervention code：

组别：

C组:0.9%NaCl对照组

样本量：

 80

Group：

Group C :0.9%NaCl control group

Sample size：

干预措施：

静脉注射4ml0.9%NaCl，硬膜外注射4ml0.9%NaCl

干预措施代码：

 C

Intervention：

intravenous injection of 4ml 0.9%NaCl, epidural injection of 4ml 0.9%NaCl

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

 西安市 

Country：

China

Province：

Shaanxi Province

City：

Xi'an city

单位(医院)：

 西北妇女儿童医院 

单位级别：

 三甲 

Institution
hospital：

Northwest Women's and Children's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后48小时内总局麻药物和吗啡消耗量

指标类型：

主要指标

Outcome：

Local anesthetic medication and morphine consumption within 48 hours after surgery

Type：

Primary indicator

测量时间点：

术后48小时

测量方法：

术后48小时移除硬膜外镇痛泵，记录药物使用总量和PCA次数。

Measure time point of outcome：

48 hours after surgery

Measure method：

Recorded and the total amount of drug used in 48 hours after surgery

指标中文名：

术后6h、12h、24h、48h静息和运动 NRS痛觉评分

指标类型：

次要指标

Outcome：

NRS Pain Scale at rest and NRS Pain Scale during movement in 48 hours after surgery

Type：

Secondary indicator

测量时间点：

术后6h、12h、24h、48h

测量方法：

NRS 痛觉评分

Measure time point of outcome：

6, 12, 24, and 48 hours after surgery

Measure method：

NRS Pain Scale

指标中文名：

机械刺激评估感觉神经阻滞时间

指标类型：

次要指标

Outcome：

sensory nerve block time by mechanical stimulation

Type：

Secondary indicator

测量时间点：

术后每30 min重复一次以评估阻滞的持续时间

测量方法：

通过使用5ml注射器的针头刺激两侧足背记录从尖锐感消失到重新出现的时间。

Measure time point of outcome：

The test was repeated every 30 min after surgery

Measure method：

The time from the disappearance of the sharp sensation to its reappearance was recorded by stimulating the dorsum of the feet on both sides with the needle of a 5ml syringe.

指标中文名：

术后双下肢运动功能恢复时间

指标类型：

次要指标

Outcome：

postoperative recovery time of motor function

Type：

Secondary indicator

测量时间点：

术后6h、12h、24h、48h

测量方法：

改良Bromage评分

Measure time point of outcome：

6h、12h、24h、48h after surgery

Measure method：

Modified Bromage score

指标中文名：

术后寒颤、恶心、呕吐、头疼、瘙痒的发生率

指标类型：

次要指标

Outcome：

Incidence of postoperative chills, nausea, vomiting, headache, itching.

Type：

Secondary indicator

测量时间点：

术后6h、12h、24h、48h

测量方法：

记录术后寒颤、恶心、呕吐、头疼、瘙痒的发生

Measure time point of outcome：

6h、12h、24h、48h after surgery

Measure method：

Recorded the occurrence of chills, nausea, vomiting, headache, and itching

指标中文名：

术后48小时内母乳喂养率

指标类型：

次要指标

Outcome：

Breastfeeding rate within 48 hours

Type：

Secondary indicator

测量时间点：

术后6h、12h、24h、48h

测量方法：

记录术后48小时内母乳喂养的时间和次数

Measure time point of outcome：

6h、12h、24h、48h after surgery

Measure method：

Recorded the duration and number of breastfeeding

指标中文名：

术后48小时舒适度评分

指标类型：

次要指标

Outcome：

General Comfort Questionnaire at 48 hours after surgery

Type：

Secondary indicator

测量时间点：

术后48小时

测量方法：

Kolcaba的舒适状况量表评估舒适度

Measure time point of outcome：

48h after surgery

Measure method：

General Comfort Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

受试者按照入组顺序编号，统计人员通过随机程序生成随机分组表，根据随机分组表制作包含随机信息的密封信封。在随机中注意年龄、ASA分级和手术医师的均衡性。待患者入选并随机化后，按相应随机号打开信封，获得随机编号。

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

Subjects were numbered in the order of enrollment, and the statistician made sealed envelopes containing randomization information according to the randomization program. Note age, ASA grade, and surgeon balance in randomization. After the patient is selected and randomized, open the envelope with the corresponding randomization number to obtain the randomization number.

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：

麻醉实施由专门的麻醉人员进行，实施操作的麻醉医生、研究指标记录者、数据登记者对分组不知情，等所有数据收集好后进行数据统计和分析时解盲。

Blinding：

The anesthetists who performed the operation, the recorders of research indicators, and the data registrants were unaware of the grouping, and the blinding was unblinded when all the data were collected and analyzed.

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）：

2024-09-01

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

2024-09-01

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 调查问卷 https://www.wjx.cn/vm/hWt7IKc.aspx https://www.wjx.cn/vm/PwFcc76.aspx

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

CRF, Network questionnaire https://www.wjx.cn/vm/hWt7IKc.aspx https://www.wjx.cn/vm/PwFcc76.aspx

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：

  2023-11-01 08:48:07