ChiCTR2200057200 版本V1.0 版本创建时间2022/10/31 11:27:53 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：

 ChiCTR2200057200 

最近更新日期：

Date of Last Refreshed on：

 2022-03-03 12:54:27 

注册时间：

Date of Registration：

 2022-03-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

多角度评估全膝关节置换术不同术后镇痛方式的优缺点： 一项随机、对照试验

Public title：

Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: A randomized, controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多角度评估全膝关节置换术不同术后镇痛方式的优缺点： 一项随机、对照试验

Scientific title：

Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: 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：

古钰 

研究负责人：

曾景阳 

Applicant：

Yu Gu 

Study leader：

Jingyang Zeng 

申请注册联系人电话：

Applicant telephone：

 18990031204

研究负责人电话：

Study leader's
telephone：

13860728258

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：

 guyu951221@163.com

研究负责人电子邮件：

Study leader's E-mail：

 serendipity1221@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.qzdyyy.com/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.qzdyyy.com/

申请注册联系人通讯地址：

福建省泉州市丰泽区安吉南路1028号

研究负责人通讯地址：

福建省泉州市丰泽区安吉南路1028号

Applicant address：

No.1028 Anji Nan road, Fengze county, Quanzhou city, Fujian province

Study leader's address：

No.1028 Anji Nan road, Fengze county, Quanzhou city, Fujian province

申请注册联系人邮政编码：

Applicant postcode：

 362000

研究负责人邮政编码：

Study leader's postcode：

 362000

申请人所在单位：

福建医科大学附属泉州第一医院

Applicant's institution：

Fujian Medical University Affiliated First Quanzhou Hospital

研究负责人所在单位：

福建医科大学附属泉州第一医院

Affiliation of the Leader：

Fujian Medical University Affiliated First Quanzhou 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：

 2020TG022

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：

福建医科大学附属泉州第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of Quanzhou First Hospital Affiliated to Fujian Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-08-27 00:00:00

伦理委员会联系人：

柳江民

Contact Name of the ethic committee：

Jiangmin Liu

伦理委员会联系地址：

福建省泉州市丰泽区安吉南路1028号

Contact Address of the ethic committee：

No.1028 Anji Nan road, Fengze county, Quanzhou city, Fujian province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 13860799167

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：

福建医科大学附属泉州第一医院

Primary sponsor：

Fujian Medical University Affiliated First Quanzhou Hospital

研究实施负责（组长）单位地址：

福建省泉州市丰泽区安吉南路1028号

Primary sponsor's address：

No.1028 Anji Nan road, Fengze county, Quanzhou city, Fujian 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)：

福建

市(区县)：

泉州

Country：

China

Province：

Fujian

City：

Quanzhou

单位(医院)：

福建医科大学附属泉州第一医院

具体地址：

丰泽区安吉南路1028号

Institution
hospital：

Quanzhou First Hospital Affiliated to Fujian Medical University

Address：

1028 Anji Road South, Fengze District

经费或物资来源：

福建省卫生健康委员会

Source(s) of funding：

Fujian Provincial Health Commission

研究疾病：

类风湿性关节炎等  

Target disease：

Rheumatoid arthritis, etc

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟从镇痛效果、不良反应发生率、凝血功能变化和下肢深静脉血栓发生率等方面评估TKR术后三种不同镇痛方式的优缺点，为该类手术提供适宜的术后镇痛方法。  

Objectives of Study：

This study explored postoperative analgesic effects, blood coagulation changings, and the incidence of adverse reactions and deep vein thrombosis in the lower limbs during continuous femoral nerve block analgesia (CFNBA), patient-controlled epidural analgesia (PCEA) and patient-controlled intravenous analgesia (PCIA) applied to total knee replacement (TKR).

药物成份或治疗方案详述：

采用随机数字表法将受试患者分成 3 组：PCIA 组、PCEA 组、CFNBA 组。每 组 20 名患者，所有患者均接受单侧 TKR。 麻醉方法如下： 所有患者麻醉方式均采用静吸复合全麻，入室后常规监护，开放外周静脉， 输注钠钾镁钙葡萄糖注射液 8ml/kg·h，术中根据病人情况调节滴速，行有创动 脉血压监测，并作血气分析。PCEA 组和 CFNBA 组于全麻诱导前分别行硬膜外置 管和股神经阻滞置管，确认安全有效后行全麻诱导。三组患者的全麻诱导和麻醉 维持相同，面罩给氧后麻醉诱导采用：依托咪酯 0.3-0.4mg/kg，舒芬太尼 0.3-0.4ug/kg,顺阿曲库铵 0.15mg/kg,阿托品 0.5mg，置入喉罩，使用 Drager 麻醉 机进行机械通气，潮气量设置为 6-8ml/kg，呼吸频率 10-12 次/分，吸呼比 1:2， 维 持 呼 气 末 二 氧 化 碳 分 压 在 35-45mmHg 。 术 中 采 用 微 量 泵 持 续 输 注 0.15ug/(kg·min)瑞芬太尼，并复合吸入 1.0%-2.0%七氟醚，术中维持 BIS 在 45-55， 并根据肌松代谢情况及手术需求追加顺阿曲库铵。术中维持血压平稳，上下波动 不超过基础血压的 20%，并根据血压、心率及尿量适当补液。 所有病例术前备好鸡尾酒疗法，带氨甲环酸 2g 入手术室静脉滴注，术后氨 甲环酸 2g+0.5%罗哌卡因 20ml 关节腔内注射局部封闭。 低分子肝素的应用如下： 三组患者均于术前 12 h，术后 12 h 和术后第 2-7 天每日腹壁皮下注射低分子 肝素（Low molecular weight heparin,LMWH），每次 50 IU /kg。参照美国胸科医 师学会（ACCP）第六届会议指南，应用 LMWH 后间隔 12 h 行椎管内穿刺置管或 拔管，置管或拔管后 4 h 后续用 LMWH。 镇痛方法和药物如下： PCIA 组：舒芬太尼 2ug/kg+地佐辛 20mg+多拉司琼 25mg，加入生理盐水稀 释至 100mL，不设负荷量，背景输注速率设置为 2mL/h，blous 量 0.5ml/次。 PCEA 组：0.1％罗哌卡因，负荷量设定为 10mL，背景输注率 5mL/h，锁定时 间 20min，blous 量 5ml/次。 CFNBA组：0.1％罗哌卡因，负荷量10ml，背景输注率5ml/h，锁定时间20min， blous 量 5ml/次。 

Description for medicine or protocol of treatment in detail：

Patients were randomly allocated to one of the following three groups: PCIA group, PCEA group or CFNBA group. There were 20 patients in each group and all patients received unilateral TKR. The anesthesia method was as follows. All patients were anesthetized by intravenous-inhalation combined anesthesia. After entering the room, they were routinely monitored. Peripheral veins were opened. Sodium potassium magnesium calcium and glucose injection was infused at 8 ml/kg·h. During the operation, the infusion rate was adjusted according to the patient's condition. Monitors included invasive blood pressure, heart rate (HR), arterial pulse oxygen saturation (SpO2), and respiratory rate. The PCEA group and the CFNBA group respectively received epidural catheterization and femoral nerve block catheterization. General anesthesia induction was performed after confirming the position of the catheter. After mask oxygen inhalation, etomidate 0.3-0.4 mg/kg, sufentanil 0.3-0.4 ug/kg, cisatracurium 0.15 mg/kg, atropine 0.5 mg was administered by putting in a laryngeal mask using Drager anesthesia machine for mechanical ventilation and setting tidal volume to 6-8 ml/kg, respiratory rate 10-12 times/min, inhalation-expiration ratio 1:2, while maintaining end-tidal carbon dioxide partial pressure between 35-45 mmHg. During the operation, a micro pump was used for continuous infusion of 0.15 μg/(kg·min) remifentanil, combined with 1.0%-2.0% sevoflurane inhalation. The BIS was maintained at 45-55 during the operation. Muscle relaxants were added according to metabolism and the surgical needs. During the operation, the blood pressure was maintained stable, and the fluctuations did not exceed 20% of the basal blood pressure. Appropriate fluids were supplemented according to blood pressure, HR and urine volume. The anesthesia induction and maintenance schemes of the three groups were the same. Cocktail therapy were prepared for all cases preoperatively. 2 g tranexamic acid was brought into the operating room for intravenous infusion, and 2 g tranexamic acid mixing with 0.5% ropivacaine for 20 ml was injected to the joint cavity postoperatively. The applications of low molecular weight heparin were as follows. The three groups were injected with low molecular weight heparin (LMWH) daily with a rate of 50 IU/kg at 12 hours before operation, 12 hours and 2-7 days after operation. According to the guidelines of the sixth meeting of the American College of Chest Physicians (ACCP), epidural intubation or extubation was performed 12 hours after the application of LMWH, and LMWH should be used 4 hours after intubation or extubation. Analgesia methods and drugs were as follows. The PCIA regimen consisted of sufentanil 2 μg/kg, 20 mg dezocine and 25 mg dolastron, mixed with 0.9% normal saline to a total volume of 100 ml. The PCIA was programmed to deliver a 0.5 ml bolus on-demand, without a loading dose, and a background infusion rate of 2 ml/h. The PCEA and CFNBA solutions consisted of 0.1% ropivacaine. They were programmed to deliver a 5 ml bolus on-demand, with a lock-out interval of 20 min, and a background infusion rate of 5 ml/h. The patients of PCEA and CFNBA group were respectively administered with 10 ml 0.1% ropivacaine through epidural catheter or continuous nerves block catheter as load dose 20 minutes before the end of surgery. 

纳入标准：

①符合相关膝关节疾病诊断标准者：②符合TKA治疗适应症者；③ASA分级为I～Ⅱ级者；④经我院伦理委员会批准者；⑤ 自愿签署知情同意书者。⑥术前凝血功能正常者；⑦术前无下肢静脉血栓者；⑧抗凝药物无用药禁忌者；⑨无椎管内阻滞禁忌证者。

Inclusion criteria

① Patients who met the diagnostic criteria of related knee diseases: ② patients who met the indications for TKA treatment; ③ASA grade I ~ ⅱ; ④ Approved by the Ethics Committee of our hospital; (5) Voluntarily signing informed consent. ⑥ The preoperative coagulation function was normal; ⑦ Patients without preoperative venous thrombosis of lower limbs; ⑧ no contraindications of anticoagulant drugs; ⑨ Patients without contraindications of spinal canal block.

排除标准：

①合并精神疾病、听力障碍、语言障碍、意识不清者；②凝血功能及血小板异常；③术前合并下肢静脉血栓；④急性炎症性皮肤病；⑤一般情况差，不能耐受手术；⑥中途退出治疗、更改术式、死亡或随访期失联者 ；⑦治疗依从性不足者。

Exclusion criteria：

① With mental illness, hearing impairment, language impairment and unconsciousness; ② Abnormal coagulation function and platelet; ③ Preoperative venous thrombosis of lower limbs; ④ Acute inflammatory skin disease; ⑤ The general condition is poor and cannot tolerate surgery; ⑥ Withdrawal from treatment, change of operation, death or loss of contact during follow-up; ⑦ Inadequate treatment compliance.

研究实施时间：

Study execute time：

从 From 2019-09-01 00:00:00至 To 2021-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-09-01 00:00:00 至 To 2021-01-31 00:00:00

干预措施：

Interventions：

组别：

PCIA组

样本量：

 20

Group：

group PCIA

Sample size：

干预措施：

舒芬太尼2ug/kg+地佐辛20mg+多拉司琼25mg，加入生理盐水稀释至100mL，不设负荷量，背景输注速率设置为2mL/h，blous量0.5ml/次

干预措施代码：

Intervention：

2ug/kg+ dezocine 20mg+ dolasetron 25mg, diluted to 100mL by adding normal saline, no loading volume was set, background infusion rate was set as 2mL/h, and blous volume was 0.5ml/ time

Intervention code：

组别：

PCEA组

样本量：

 20

Group：

group PCEA

Sample size：

干预措施：

0.1％罗哌卡因，负荷量设定为 10mL，背景输注率 5mL/h，锁定时间 20min，blous 量 5ml/次

干预措施代码：

Intervention：

0.1% ropivacaine, load set at 10mL, background infusion rate of 5mL/h, locking time of 20min, blous dose of 5ml/ time

Intervention code：

组别：

CFNBA组

样本量：

 20

Group：

group CFNBA

Sample size：

干预措施：

0.1％罗哌卡因，负荷量10ml，背景输注率5ml/h，锁定时间20min，blous 量 5ml/次

干预措施代码：

Intervention：

0.1% ropivacaine, loading volume 10ml, background infusion rate 5ml/h, locking time 20min, blous volume 5ml/ time

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 泉州 

Country：

China

Province：

Fujian

City：

Quanzhou

单位(医院)：

 福建医科大学附属泉州第一医院 

单位级别：

 三甲 

Institution
hospital：

Fujian Medical University Affiliated First Quanzhou Hospital

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：

pain score

Type：

Primary indicator

测量时间点：

术后第一、二天

测量方法：

VAS评分量表

Measure time point of outcome：

1st and 2nd day after surgery

Measure method：

VAS rating scale

指标中文名：

不良反应

指标类型：

主要指标

Outcome：

Adverse reactions

Type：

Primary indicator

测量时间点：

术后第一、二天

测量方法：

询问和观察

Measure time point of outcome：

1st and 2nd day after surgery

Measure method：

ask and observe

指标中文名：

凝血指标

指标类型：

次要指标

Outcome：

coagulation indicators

Type：

Secondary indicator

测量时间点：

术前，术后第一、二天

测量方法：

抽血化验

Measure time point of outcome：

Before surgery, 1st and 2nd day after surgery

Measure method：

blood test

指标中文名：

下肢深静脉血栓发生率

指标类型：

次要指标

Outcome：

the incidence of deep vein thrombosis in the lower extremities

Type：

Secondary indicator

测量时间点：

术后第一、二天

测量方法：

B超扫查

Measure time point of outcome：

1st and 2nd day after surgery

Measure method：

Ultrasound scan

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

blood

Tissue：

blood

人体标本去向

 使用后销毁  

说明

检测完立即销毁

Fate of sample：

Destruction after use  

Note：

Destroy immediately after detection

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 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）：

项目负责人；随机数字表法

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

Project leader ；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：

双盲：对研究实施者和研究对象均设盲

Blinding：

Double-blind: blinded to both the researcher and the research subjects

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）：

链接: https://pan.baidu.com/s/1CZMGf0J1A3xeUefgJwMzCg 提取码: ijw2 复制这段内容后打开百度网盘手机App，操作更方便哦 --来自百度网盘超级会员v6的分享

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

链接: https://pan.baidu.com/s/1CZMGf0J1A3xeUefgJwMzCg 提取码: ijw2 复制这段内容后打开百度网盘手机App，操作更方便哦 --来自百度网盘超级会员v6的分享

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：

保存至百度网盘

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

Save it on the Baidu web disk

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-03-03 12:54:27