ChiCTR2200065065 版本V1.2 版本创建时间2023/06/19 22:26:32 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：

 ChiCTR2200065065 

最近更新日期：

Date of Last Refreshed on：

 2023-04-25 21:51:06 

注册时间：

Date of Registration：

 2022-10-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

艾司氯胺酮复合罗哌卡因对膝关节置换术患者术后疼痛影响

Public title：

Effect of esketamine combined with ropivacaine on postoperative pain in patients with joint replacement

注册题目简写：

English Acronym：

研究课题的正式科学名称：

艾司氯胺酮复合罗哌卡因对膝关节置换术患者术后疼痛影响

Scientific title：

Effect of esketamine combined with ropivacaine on postoperative pain in patients with joint replacement

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：

程志 

研究负责人：

程志 

Applicant：

chengzhi 

Study leader：

chengzhi 

申请注册联系人电话：

Applicant telephone：

 +86 18961321396

研究负责人电话：

Study leader's
telephone：

+86 18961321396

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：

 547694630@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 547694630@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：

江苏省连云港市海州区振华东路6号

研究负责人通讯地址：

江苏省连云港市海州区振华东路6号

Applicant address：

No. 6 Zhenhua East Road, Haizhou District, Lianyungang City, Jiangsu Province

Study leader's address：

No. 6 Zhenhua East Road, Haizhou District, Lianyungang City, Jiangsu Province

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：

连云港市第一人民医院

Applicant's institution：

The First People's Hospital of Lianyuangang

研究负责人所在单位：

连云港市第一人民医院

Affiliation of the Leader：

The First People's Hospital of Lianyuangang

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：

 KY-20220507001-01

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：

连云港市第一人民医院医学伦理委员会

Name of the ethic committee：

The First People's Hospital of Lianyuangang Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-13 00:00:00

伦理委员会联系人：

高山

Contact Name of the ethic committee：

gaoshan

伦理委员会联系地址：

江苏省连云港市海州区振华东路6号

Contact Address of the ethic committee：

No. 6 Zhenhua East Road, Haizhou District, Lianyungang City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 518 85767557

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：

连云港市第一人民医院

Primary sponsor：

The First People's Hospital of Lianyuangang

研究实施负责（组长）单位地址：

江苏省连云港市海州区振华东路6号

Primary sponsor's address：

6 Zhenhua East Road, Haizhou District, Lianyungang, Jiangsu

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)：

连云港

Country：

China

Province：

Jiangsu

City：

Lianyungang

单位(医院)：

连云港市第一人民医院

具体地址：

江苏省连云港市海州区振华东路6号

Institution
hospital：

The First People's Hospital of Lianyuangang

Address：

6 Zhenhua Road East, Haizhou District, Lianyungang, Jiangsu

经费或物资来源：

连云港市第一人民医院

Source(s) of funding：

The First People's Hospital of Lianyuangang

研究疾病：

手术患者  

Target disease：

surgery patient

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：

膝关节置换术是关节外科常见的手术，超声引导下神经阻滞已被应用用于缓解膝关节置换术手术后疼痛。艾司氯胺酮是一种NMDA拮抗剂，可以延长周围神经阻滞的持续时间，本研究旨在证明超声引导下艾司氯胺酮复合罗哌卡因作用于股神经能否减轻患者膝关节置换术术后疼痛，延长罗哌卡因的作用时间。  

Objectives of Study：

Randomized knee arthroplasty is a common procedure in joint surgery, and ultrasound-guided nerve blocks have been used to relieve pain after knee arthroplasty. Esketamine, an NMDA antagonist, can prolong the duration of peripheral nerve block. The purpose of this study was to demonstrate whether ultrasound-guided esketamine combined with ropivacaine on the femoral nerve can reduce postoperative knee arthroplasty in patients. Pain, prolongs the duration of action of ropivacaine.

药物成份或治疗方案详述：

选择择期行人工膝关节置换患者60例，随机分为2组。入手术室后记录心率(HR)、血氧饱和度(SPO2)、血压、平均动脉压(MAP)。罗哌卡因组行超声引导下0.25%罗哌卡因 15ml 股神经阻滞，艾司氯胺酮复合罗哌卡因组行超声引导下0.25%罗哌卡因15ml +艾司氯胺酮20mg 股神经阻滞。 麻醉诱导：依此缓慢静脉注射舒芬太尼0.2～0.5μg／kg、丙泊酚1～2.5 mg／kg、顺式阿曲库铵0.1～0.2 mg／kg，预充氧后气管插管接麻醉机行机械通气，FiO2 60％，VT 6～8 ml／kg，RR 12～15次／分，I∶E 1∶2，PETCO2 35～45 mmHg。 麻醉维持：丙泊酚复合瑞芬太尼全凭静脉麻醉，顺式阿曲库铵 0.1～0.2 mg/（kg·h）维持适当肌松。记录麻醉开始后1h时心率(HR)、血氧饱和度(SPO2)、血压、平均动脉压(MAP) 术毕停止输注丙泊酚和瑞芬太尼。待患者自主呼吸充分恢复后拔除气管插管，送入PACU继续观察，符合Steward苏醒评分6分以上送回病房。记录患者神经阻滞后4, 6, 8, 20, 24的视觉模拟量表疼痛评分，术后下床活动时间，术后并发症，阿片类药物使用剂量。 

Description for medicine or protocol of treatment in detail：

All study solutions were prepared by one nurse. To make 40 ml of 0.25% ropivacaine for Group A, ropivacaine 100 mg/10 ml (Naropin?; AstraZeneca AB, Sodertalje, Sweden) was diluted with 30 ml of 0.9% saline (Baxter Healthcare). For Group B, we diluted esketamine 50mg/2 ml (Precedex, Hengrui. Lianyungang, China) with 18 ml of 0.9% saline to obtain a volume of 20 ml. The volume of diluted esketamine administered to the patient was calculated based on patient weight; for example, for a 50-kg patient, 10 ml of esketamine solution was combined with 10 ml of Naropin and 20 ml of 0.9% saline. In this way, we made 40 ml of 0.25% ropicacaine combined with0.5 mg/kg esketamine for Group B. After positioning the patient, a line was drawn between the anterior superior iliac spine and the pubic tubercle (along the inguinal ligament), followed by routine disinfection and draping. A high-frequency ultrasound transducer (10–13 MHz, SonoSite S-Nerve, Bothell, WA, USA) was placed parallel to the inguinal ligament. The femoral artery was identified at the intersection of inguinal ligament and the skin crease at the proximal end of the thigh. The fascia iliaca and iliopsoas muscle were identified lateral to the femoral artery. A 20-ga venous cannula was inserted in plane with the transducer at the lateral end of the thigh. After negative aspiration, 2–5 ml of 0.9% saline (Baxter Healthcare) was injected to confirm the appropriate plane of injection between the fascia and the iliopsoas muscle. This was followed by injection of 40 ml of the local anesthetic solution (0.25% ropivacaine or 0.25% ropivacaine combined with 0.5 mg/kg esketamine) after the saline was seen to spread along the fascia iliaca. The block was considered to be effective if sensation decreased along the anterior, medial, and lateral thigh 20 min later and we may not include the patient if his/her FICB was failed. After sensory assessment, all patients were given GA using standard hospital protocol and monitored with ASA monitoring. GA was administered using 5 mg/kg Sodium thiopentone and 0.5 mg/kg atracurium intravenously (IV) followed by tracheal intubation using appropriate size endotracheal tube. GA was maintained with sevoflurane and oxygen mixture titrated to a MAC level of 0.8 to 1. All patients were ventilated with a tidal volume of 6 -8mL/kg at rate titrated to EtCO2 between 30 to 40 mm Hg. Ephedrine 10 mg or urapidil 15 mg was administered to maintain mean arterial pressure within 20% of baseline. When heart rate was less than 50 bpm or more than 120 bpm, 0.5 mg atropine or 10–30 mg of esmolol, respectively, was injected. Time to first analgesic request was defined as time taken by the patient to activate first demand dose of PCA sufentanil from the time of extubation. This time period is taken as the duration of postoperative analgesia offered by the FICB. Number of used PCA boluses of sufentanil at 0 to 2 h, 2 to 4 h, 4 to 6 h, 6 to 8 h, 8 to 12 h and 12 to 24 h was noted and the total consumption of sufentanil in 24 h was calculated. Intravenous paracetamol of 1 g as rescue medication over 5 min was given to ensure NRS below 4 at movement. Data were collected using data collection proforma during intraoperative and post-operative period. We noted the VAS scores at 2,4, 6, 8, 12, and 24 h after the FICB; the Ramsay sedation scores were also recorded. Heart rates at various time points, the postoperative dose of analgesics, and any adverse drug reactions such as hypotension, hypertension respiratory depression, nausea, vomiting, and urinary retention were also recorded. 

纳入标准：

患者必须满足以下所有入选标准才可入组本研究：
1.55≤年龄≤75 岁，性别不限；
2.行择期膝关节置换手术；
3.ASA 评分为Ⅰ级或Ⅱ级；
4.18 kg/m^2＜BMI＜30kg/m^2；
5.清楚了解、自愿参加该项研究，并由其本人签署知情同意书

Inclusion criteria

Patients must meet all of the following inclusion criteria to be included in this study:
1. 55 <= age <=75 years old, regardless of gender;
2. Elective knee replacement surgery;
3. ASA grade I or II;
4. 18 kg/m^2 < BMI<30kg/m^2;
5. Clearly understand and voluntarily participate in the study, and sign the informed consent form by himself/herself

排除标准：

具有以下任何一项的患者不能入组本研究：
1.急诊手术； 低血容量、 休克或者昏迷状态；
2.计划行椎管内麻醉或硬膜外麻醉
3.感染性心脏疾病如心肌炎或心内膜炎；败血症；
4.凝血功能异常（PT 或 INR≥1.5×ULN， APTT≥1.5×ULN）；
5.肝功能异常， AST 和/或 ALT≥2.5×ULN， TBIL≥1.5×ULN；
6.肾功能异常， 尿素或尿素氮≥1.5×ULN，血肌酐大于正常值上限；
7.急性心力衰竭； 不稳定型心绞痛；筛选前 6 个月内发生心肌梗死；静息心电图心率≤50 次/分；三度房室传导阻滞等严重心律失常；严重的心脏瓣膜疾病； QTc：男性≥450 ms，女性≥470 ms；
8.血压未获满意控制的高血压患者（筛选期坐位收缩压≥160 mmHg，
和/或筛选期舒张压≥100 mmHg）；
9.筛选期坐位收缩压≤90 mmHg；
10.血糖未获满意控制的糖尿病患者（筛选期血糖≥11.1 mmol/L）；
11.筛选前 2 年内有吸毒史和/或酗酒史，酗酒即每日平均饮酒超过 2 单位酒精（1单位=360 mL啤酒或 45 mL酒精量为 40%的白酒或 150 mL葡萄酒）；
12.患有精神系统疾病（精神分裂症、躁狂症、两极型异常、精神错乱等）及长期服用精神类药物史及认知功能障碍者；
13.艾司氯胺酮、阿片类药物、丙泊酚、 肌松类等药物及其药物组分过敏或有禁忌者；
14.被判定为呼吸道管理有困难的患者（改良马氏评分为Ⅳ级）；
15.研究者认为不宜参加此试验的其他情况。

Exclusion criteria：

Patients with any of the following were not eligible for this study:
1. Emergency surgery; hypovolemia, shock, or coma;
2. Planned spinal or epidural anaesthesia;
3. Infectious heart disease such as myocarditis or cardiac Endocarditis; sepsis;
4. Abnormal coagulation function (PT or INR >= 1.5*ULN, APTT >= 1.5*ULN);
5. Abnormal liver function, AST and/or ALT >= 2.5*ULN, TBIL >= 1.5*ULN;
6. Abnormal renal function, urea or urea nitrogen >= 1.5*ULN, serum creatinine greater than the upper limit of normal;
7. Acute heart failure; Unstable angina; myocardial infarction within 6 months before screening; resting ECG heart rate <= 50 beats/ Severe arrhythmias such as third-degree atrioventricular block; severe heart valve disease; QTc: >= 450 ms for males, >= 470 ms for females;
8. Hypertensive patients with unsatisfactory control of blood pressure (sitting systolic blood pressure >= 160 mmHg, and/or diastolic blood pressure >= 100 mmHg during screening);
9. Sitting systolic blood pressure <= 90 mmHg during screening;
10. Diabetic patients with unsatisfactory control of blood glucose (blood glucose >= 11.1 mmol/L during screening);
11. Screening History of drug and/or alcohol abuse in the previous 2 years, which means drinking more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol content or 150 mL of wine);
12. Suffering from mental illness Systemic diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and long-term use of psychotropic drugs and cognitive dysfunction;
13. Esketamine, opioids, propofol, muscle relaxants Those who are allergic to or have contraindications to other drugs and their drug components;
14. Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV);
15. Other situations that the investigator considers inappropriate to participate in this trial.

研究实施时间：

Study execute time：

从 From 2022-11-01 00:00:00至 To 2024-12-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-11-01 00:00:00 至 To 2024-12-12 00:00:00

干预措施：

Interventions：

组别：

单药组

样本量：

 30

Group：

Monotherapy group

Sample size：

干预措施：

罗哌卡因

干预措施代码：

Intervention：

Ropivacaine

Intervention code：

组别：

复合组

样本量：

 30

Group：

Composite group

Sample size：

干预措施：

艾司氯胺酮复合罗哌卡因

干预措施代码：

Intervention：

Esketamine combined with ropivacaine

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)：

 连云港 

Country：

China

Province：

Jiangsu

City：

Lianyungang

单位(医院)：

 连云港市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

The First People's Hospital of Lianyuangang

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛评分

指标类型：

主要指标

Outcome：

VAS

Type：

Primary 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：

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 55 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机抽样

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

random sampling

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

N/A

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）：

院内

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

hospital

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：

为病例记录表

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：

有/Yes

注册人：

Name of Registration：

  2022-10-27 09:40:07