ChiCTR2300078310 版本V1.0 版本创建时间2023/12/05 08:55:30 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：

 ChiCTR2300078310 

最近更新日期：

Date of Last Refreshed on：

 2023-12-05 08:53:20 

注册时间：

Date of Registration：

 2023-12-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

S-氯胺酮与剖宫产术后疼痛

Public title：

S-ketamine and cesarean section postoperative pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

S-氯胺酮复合麻醉改善剖宫产镇痛效果的随机对照研究

Scientific title：

S-Ketamine combined Anesthesia in improving the Analgesia effect of Cesarean Section: a randomized 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：

张峻华 

研究负责人：

张峻华 

Applicant：

Junhua Zhang 

Study leader：

Junhua Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 152 1368 0591

研究负责人电话：

Study leader's
telephone：

+86 152 1368 0591

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：

 272073444@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 272073444@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：

重庆市涪陵区高笋塘路2号

研究负责人通讯地址：

重庆市涪陵区高笋塘路2号

Applicant address：

2 Gaosuntang Road, Fuling District, Chongqing

Study leader's address：

2 Gaosuntang Road, Fuling District, Chongqing

申请注册联系人邮政编码：

Applicant postcode：

 408000

研究负责人邮政编码：

Study leader's postcode：

 408000

申请人所在单位：

重庆大学附属涪陵医院

Applicant's institution：

Fuling Hospital Affiliated to Chongqing University

研究负责人所在单位：

重庆大学附属涪陵医院

Affiliation of the Leader：

Fuling Hospital Affiliated to Chongqing 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：

 2023CDFSFLYYEC-064

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：

重庆大学附属涪陵医院伦理委员会

Name of the ethic committee：

Ethics Committee of Fuling Hospital Affiliated to Chongqing University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-17 00:00:00

伦理委员会联系人：

李严

Contact Name of the ethic committee：

Yan Li

伦理委员会联系地址：

重庆市涪陵区高笋塘路2号

Contact Address of the ethic committee：

2 Gaosuntang Road, Fuling District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 7222 6537

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：

重庆大学附属涪陵医院

Primary sponsor：

Fuling Hospital Affiliated to Chongqing University

研究实施负责（组长）单位地址：

重庆市涪陵区高笋塘路2号

Primary sponsor's address：

2 Gaosuntang Road, Fuling District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

涪陵

Country：

China

Province：

Chongqing

City：

Fuling

单位(医院)：

重庆大学附属涪陵医院

具体地址：

重庆市涪陵区高笋塘路2号

Institution
hospital：

Chongqing University Fuling Hospital

Address：

2 Gaosuntang Road, Fuling District, Chongqing

经费或物资来源：

自筹经费

Source(s) of funding：

Self-raised funds

研究疾病：

剖宫产术后疼痛  

Target disease：

Cesarean section postoperative 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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

验证围术期应用S-氯胺酮可以有效减轻剖宫产术后疼痛，帮助其快速康复。 证实围术期应用S-氯胺酮的产妇术后炎症反应及痛觉敏化程度显著低于对照组，验证S-氯胺酮减轻剖宫产术后疼痛的潜在机制  

Objectives of Study：

It is proved that the perioperative application of S-ketamine can effectively reduce the pain after cesarean section and help the patients recover quickly. It was confirmed that the postoperative inflammation and hyperalgesia of the S-ketamine group was significantly lower than that of the control group, and the potential mechanism of S-ketamine alleviating pain after cesarean section was verified

药物成份或治疗方案详述：

常规腰硬联合麻醉和经子宫下段纵切口剖宫产手术。断脐后缓慢静脉注射盐酸S-氯胺酮0.5mg/Kg,给药时间限定60±10秒。术毕连接启动患者自控静脉镇痛泵，泵内配置S-氯胺酮0.5mg/Kg+舒芬太尼2μg/Kg,以0.9%生理盐水稀释至100ml。 

Description for medicine or protocol of treatment in detail：

Conventional combined epidural anesthesia and longitudinal incision through the lower section of the uterus caesarean section.After umbilical rupture, S-ketamine hydrochloride 0.5mg/Kg was slowly injected intravenously, and the administration time was limited to 60±10 seconds.After the operation, the patient-controlled intravenous analgesia pump was connected and started. The pump was configured with S-ketamine 0.5mg/Kg+ Sufentanil 2μg/Kg and diluted to 100ml with 0.9% normal saline. 

纳入标准：

⑴20-45岁； ⑵择期椎管内麻醉下行剖宫产术的单胎产妇 ⑶ASA II-III级 ⑷自愿参加本研究并签署知情同意书

Inclusion criteria

(1) 20-45 years old; (2) Single pregnant women who underwent cesarean section under elective spinal anesthesia (3) ASA II-III (4) Voluntarily participated in the study and signed the informed consent

排除标准：

⑴ 合并剖宫产禁忌症如：宫内死胎、胎儿畸形、母体不能耐受手术、胎儿宫内窘迫等的产妇； ⑵ 合并椎管内麻醉禁忌症如：凝血功能障碍、中枢系统疾病等的产妇； ⑶ 合并使用艾斯氯胺酮禁忌症如：甲亢、严重高血压、先兆子痫、精神障碍、需松弛子宫的情况如脐带脱垂和子宫破裂等的产妇； ⑷ 酗酒及长期服用阿片类药物、激素类药物及抗炎镇痛药物的产妇； ⑸ 对试验中所用药物过敏的产妇； ⑹ 无法配合研究或拒绝参与研究的产妇。

Exclusion criteria：

(1) parturients with contraindications for cesarean section, such as intrauterine stillbirth, fetal malformation, maternal intolerance to surgery, fetal distress, etc.; (2) parturients with contraindications to intraspinal anesthesia such as coagulation dysfunction and central system diseases; (3) parturients with contraindications to esketamine, such as hyperthyroidism, severe hypertension, preeclampsia, mental disorders, need to relax the uterus, such as umbilical cord prolapse and uterine rupture. (4) pregnant women who were addicted to alcohol and took opioids, hormones and anti-inflammatory and analgesic drugs for a long time; (5)parturients were allergic to the drugs used in the trial; and (6)those who could not cooperate with the study or refused to participate in the study.

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2026-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-05 00:00:00 至 To 2025-01-01 00:00:00

干预措施：

Interventions：

组别：

E组

样本量：

 50

Group：

Group E

Sample size：

干预措施：

断脐后即刻缓慢静脉注射盐酸S-氯胺酮注射液0.5mg/Kg,给药时间限定60±10秒。术毕连接启动患者自控静脉镇痛泵，泵内配置S-氯胺酮0.5mg/Kg+舒芬太尼2μg/Kg,以0.9%生理盐水稀释至100ml。泵参数设置：背景剂量2ml/h，追加剂量1ml，锁定时间15min，每小时最大剂量6ml。

干预措施代码：

 E

Intervention：

Immediately after severing the umbilical cord, S-ketamine hydrochloride injection 0.5mg/Kg was injected intravenously, and the administration time was limited to 60 ±10 seconds. At the end of the operation, the patient-controlled intravenous analgesia pump was connected and started, and the pump was equipped with S-ketamine 0.5mg Unikg + sufentanil 2 μ g / Kg, diluted to 100ml with 0.9% normal saline. Pump parameter settings: background dose 2ml/h, additional dose 1ml, locking time 15min, maximum dose 6ml per hour.

Intervention code：

组别：

C组

样本量：

 50

Group：

Group C

Sample size：

干预措施：

断脐后即刻给予与盐酸S-氯胺酮注射液等量生理盐水。术毕连接启动患者自控静脉镇痛泵，泵内配置舒芬太尼2μg/Kg，用0.9%生理盐水稀释至100ml。泵参数设置：背景剂量2ml/h，追加剂量1ml，锁定时间15min，每小时最大剂量6ml。

干预措施代码：

 C

Intervention：

Immediately after the umbilical cord was severed, the same amount of normal saline was given to S-ketamine hydrochloride injection. After the operation, the patient-controlled intravenous analgesia pump was connected and started, which was equipped with sufentanil 2 μ g / Kg and diluted to 100ml with 0.9% normal saline. Pump parameter settings: background dose 2ml/h, additional dose 1ml, locking time 15min, maximum dose per hour 6

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

 涪陵 

Country：

China

Province：

Chongqing

City：

Fuling

单位(医院)：

 重庆大学附属涪陵医院 

单位级别：

 三甲 

Institution
hospital：

Fuling Hospital Affiliated to Chongqing University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后24h最高疼痛NRS评分。

指标类型：

主要指标

Outcome：

maxmum pain NRS score 24h postoperatively

Type：

Primary indicator

测量时间点：

术后0-6h、6-12h、12-24h

测量方法：

疼痛数字评分(NRS)法（0分为无痛，1-3分为轻度疼痛，4-6分为中度疼痛，7-10分为重度疼痛）

Measure time point of outcome：

0-6h,6-12h,12-24h postoperatively

Measure method：

(0,1-3,4-6,7-10)

指标中文名：

压痛阈值

指标类型：

次要指标

Outcome：

Pressure pain threshold

Type：

Secondary indicator

测量时间点：

术前、术后30分钟、术后24小时

测量方法：

用压痛测试仪垂直于优势手前臂，缓慢匀速加压，当产妇诉感到疼痛时压痛仪显示的数值即为压痛阈值。取肘前折痕远心端3、6、9cm三点测得值的平均值

Measure time point of outcome：

preoperative,30min postoperatiely, 24h postoperatively

Measure method：

Pressure pain threshold was mesasured using an algometer(in Kgf)), Vertical contact with the skin and then increased the pressure gradually until pregnant complained of pain, we recorded the pressure pain threshold.The mean value was measured on the skin at 3, 6, and 9 cm from the anterior elbow crease on the medial forearm.

指标中文名：

压痛耐受值

指标类型：

次要指标

Outcome：

Pressure pain tolerance

Type：

Secondary indicator

测量时间点：

术前、术后30分钟、术后24小时

测量方法：

测得压痛阈值后继续缓慢匀速加压，当产妇自诉疼痛不能忍受时的测得值即为压痛耐受值。取肘前折痕远心端3、6、9cm三点测得值的平均值

Measure time point of outcome：

preoperative,30min postoperatiely, 24h postoperatively

Measure method：

After the press pain threshold was measured, the pressure was increased slowly and uniformly, and the measured value was the press pain tolerance when the parturient reported that the pain was unbearable. The average values of 3, 6 and 9cm measured at the distal end of the front crease of the elbow

指标中文名：

血清C反应蛋白浓度

指标类型：

次要指标

Outcome：

Serum C-reactive protein concentration

Type：

Secondary indicator

测量时间点：

术前、术后24小时

测量方法：

Measure time point of outcome：

preoperative, 24h postoperatively

Measure method：

指标中文名：

术后首次按压患者自控镇痛的时间

指标类型：

次要指标

Outcome：

The time of patient-controlled analgesia for the first time after operation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者自控镇痛泵按压次数

指标类型：

次要指标

Outcome：

Number of compressions of patient-controlled analgesia

Type：

Secondary indicator

测量时间点：

术后0-6h、6-12h、12-24h

测量方法：

Measure time point of outcome：

0-6h,6-12h,12-24h postoperatively

Measure method：

指标中文名：

患者自控镇痛泵药物用量

指标类型：

次要指标

Outcome：

Patient-controlled analgesia pump drug dosage

Type：

Secondary indicator

测量时间点：

术后0-6h、6-12h、12-24h

测量方法：

Measure time point of outcome：

0-6h,6-12h,12-24h postoperatively

Measure method：

指标中文名：

曲马多用量

指标类型：

次要指标

Outcome：

Dosage of Tramadol

Type：

Secondary indicator

测量时间点：

术后0-24小时

测量方法：

Measure time point of outcome：

0-24 hours postoperative

Measure method：

指标中文名：

焦虑发生率

指标类型：

次要指标

Outcome：

Incidence of anxiety

Type：

Secondary indicator

测量时间点：

术后2天

测量方法：

广泛性焦虑障碍量表-7进行评估，≥5分诊断焦虑

Measure time point of outcome：

2 days postoperatively

Measure method：

Generalized anxiety disorder scale -7 for evaluation, ≥ 5 points for diagnosis of anxiety

指标中文名：

抑郁发生率

指标类型：

次要指标

Outcome：

Incidence of depression

Type：

Secondary indicator

测量时间点：

术后2天

测量方法：

爱丁堡产后抑郁量表评估，≥9分诊断抑郁

Measure time point of outcome：

2 days postoperatively

Measure method：

Edinburgh Postnatal Depression Scale for evaluation, ≥ 9 points for diagnosis of depression

指标中文名：

睡眠障碍发生率

指标类型：

次要指标

Outcome：

Incidence of sleep disorders

Type：

Secondary indicator

测量时间点：

术后2天

测量方法：

雅典失眠量表评估，≥6分提示睡眠障碍

Measure time point of outcome：

2 days postoperatively

Measure method：

Evaluated by Athens insomnia scale, ≥ 6 points indicate sleep disorder

指标中文名：

S-氯胺酮药物副反应发生率

指标类型：

次要指标

Outcome：

Incidence of side effects of S-ketamine

Type：

Secondary indicator

测量时间点：

术后0-24h

测量方法：

Measure time point of outcome：

0-24 hours postoperatively

Measure method：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 45 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）：

由一名独立的研究者通过SPSS软件产生随机数字。

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

Random numbers were generated by an independent researcher using SPSS 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：

由临床麻醉医生负责术中麻醉管理及数据记录，由经过培训的研究人员负责围术期评估和镇痛泵数据收集，麻醉医师与研究人员均不知晓产妇随机分组情况；统计分析由重庆大学附属涪陵医院统计室负责完成；所有产妇术中均使用统一外观和剂量的药液，术后静脉自控镇痛泵也外观统一。

Blinding：

The clinical anesthesiologist was responsible for intraoperative anesthesia management and data recording, and the trained researchers were responsible for perioperative assessment and analgesia pump data collection. Neither the anesthesiologist nor the researchers were aware of the maternal randomization;The statistical analysis was carried out by the Statistical Department of Fuling Hospital Affiliated to Chongqing University.The uniform appearance and dosage of liquid medicine were used in all obstetric procedures, and the appearance of postoperative self-controlled intravenous analgesia pump was also uniform.

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）：

本次研究的原始数据可通过电子邮件向研究团队提出合理要求

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

The individual participant data for this study is available from the sponsor on reasonable request through email

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：

由CRF表进行记录和保存

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

It is recorded and saved by CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-12-05 08:53:20