ChiCTR2600117149 版本V1.0 版本创建时间2026/01/20 15:43:36 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：

ChiCTR2600117149 

最近更新日期：

Date of Last Refreshed on：

2026-01-20 15:43:16 

注册时间：

Date of Registration：

2026-01-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

髂筋膜阻滞联合腘动脉与膝关节后囊间隙阻滞在全膝关节置换术术后镇痛的应用

Public title：

Application of Fascia Iliaca Compartment Block Combined with Infiltration between the Popliteal Artery and Capsule of the Knee for Postoperative Analgesia after Total Knee Arthroplasty

注册题目简写：

English Acronym：

研究课题的正式科学名称：

髂筋膜阻滞联合腘动脉与膝关节后囊间隙阻滞在全膝关节置换术术后镇痛的应用

Scientific title：

Application of Fascia Iliaca Compartment Block Combined with Infiltration between the Popliteal Artery and Capsule of the Knee for Postoperative Analgesia after Total Knee Arthroplasty

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：

李玉宝 

研究负责人：

李玉宝 

Applicant：

Li Yubao 

Study leader：

Li Yubao 

申请注册联系人电话：

Applicant telephone：

+86 185 6039 5821

研究负责人电话：

Study leader's telephone：

+86 185 6039 5821

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：

zibolyb@163.com

研究负责人电子邮件：

Study leader's E-mail：

zibolyb@163.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：

山东省淄博市周村区新建路1166号,淄博市中医医院手术室

研究负责人通讯地址：

山东省淄博市周村区新建路1166号,淄博市中医医院手术室

Applicant address：

No. 1166 Xinjian Road, Zhoucun District, Zibo City, Shandong Province, Zibo Traditional Chinese Medicine Hospital Operating Room

Study leader's address：

No. 1166 Xinjian Road, Zhoucun District, Zibo City, Shandong Province, Zibo Traditional Chinese Medicine Hospital Operating Room

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：

淄博市中医医院

Applicant's institution：

Zibo Traditional Chinese Medicine Hospital

研究负责人所在单位：

淄博市中医医院

Affiliation of the Leader：

Zibo Traditional Chinese Medicine Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-伦审-070

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：

淄博市中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Zibo Traditional Chinese Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-12-31 00:00:00

伦理委员会联系人：

周合剑

Contact Name of the ethic committee：

Zhou hejian

伦理委员会联系地址：

山东省淄博市周村区新建路1166号,淄博市中医医院医务科

Contact Address of the ethic committee：

No. 1166 Xinjian Road, Zhoucun District, Zibo City, Shandong Province, Medical Department of Zibo Traditional Chinese Medicine Hospital

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 533 669 9321

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：

淄博市中医医院

Primary sponsor：

Zibo Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

山东省淄博市周村区新建路1166号

Primary sponsor's address：

No. 1166 Xinjian Road, Zhoucun District, Zibo City, Shandong 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)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

淄博市中医医院

具体地址：

山东省淄博市周村区新建路1166号

Institution
hospital：

Zibo Traditional Chinese Medicine Hospital

Address：

No. 1166 Xinjian Road, Zhoucun District, Zibo City, Shandong Province

经费或物资来源：

自筹

Source(s) of funding：

Self financing

Target disease：

Postoperative analgesia after total knee arthroplasty

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探讨髂筋膜阻滞联合腘动脉与膝关节后囊间隙阻滞对全膝关节置换术患者术后镇痛及早期功能康复的影响  

Objectives of Study：

To investigate the effects of fascia iliaca compartment block combined with Infiltration between the popliteal artery and capsule of the knee on postoperative analgesia and early functional recovery in patients undergoing total knee arthroplasty

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄50-80周岁； 2.计划行初次单侧全膝关节置换术； 3.经影像学与临床诊断确诊为原发性膝关节骨关节炎（Kellgren-Lawrence分级Ⅲ-Ⅳ级）； 4.美国麻醉医师协会（ASA）身体状况分级为Ⅰ-Ⅱ级； 5.意识清楚，具备良好沟通能力，能够理解研究内容并配合完成评估； 6.自愿参加并签署书面知情同意书。

Inclusion criteria

1. Aged 50 to 80 years old; 2. Scheduled for primary unilateral total knee arthroplasty; 3. Diagnosed with primary knee osteoarthritis (Kellgren-Lawrence grade Ⅲ-Ⅳ) by imaging and clinical examination; 4. American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅱ; 5. Conscious, with good communication skills, able to understand the research content and cooperate in completing the evaluation; 6. Voluntarily participate and sign a written informed consent form.

排除标准：

1.对局部麻醉药物过敏者； 2.存在凝血功能障碍（血小板计数＜100×10?/L或INR＞1.5）； 3.合并严重心、肺、肝、肾功能不全（心功能NYHAⅢ–Ⅳ级、肺功能FEV1＜50%预计值、肝功能Child-Pugh C级或肾功能eGFR＜30 mL/min/1.73m2）； 4.有精神疾病史或认知功能障碍无法配合评估； 5.既往有同侧膝关节手术史； 6.妊娠或哺乳期妇女； 7.拒绝参与本研究或无法签署知情同意书者。

Exclusion criteria：

1. Patients with hypersensitivity to local anesthetics; 2. Patients with coagulation disorders (platelet count < 100 × 10^9/L or INR > 1.5); 3. Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction (NYHA class Ⅲ–Ⅳ cardiac function, forced expiratory volume in one second (FEV1) < 50% of predicted value, Child-Pugh class C liver function, or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2); 4. Patients with a history of mental illness or cognitive impairment who are unable to cooperate with the evaluation; 5. Patients with a previous history of ipsilateral knee joint surgery; 6. Pregnant or lactating women; 7. Patients who refuse to participate in this study or are unable to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2025-02-01 00:00:00至 To 2025-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-06 00:00:00 至 To 2025-10-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

40

Group：

Experimental group

Sample size：

干预措施：

在髂筋膜阻滞基础上行腘动脉与膝关节后囊间隙阻滞

干预措施代码：

Intervention：

Infiltration between the popliteal artery and capsule of the kneeon on the basis of fascia iliaca block

Intervention code：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

髂筋膜阻滞

干预措施代码：

Intervention：

Fascia iliaca block

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

淄博市中医医院 

单位级别：

三甲 

Institution
hospital：

Zibo Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分

指标类型：

主要指标

Outcome：

Visual Analogue Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后24h内膝关节主动屈曲角度≥90°的患者比例

指标类型：

次要指标

Outcome：

Proportion of patients with active knee flexion angle >= 90° within 24 hours after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后48h内能在辅助下行走≥10米的患者比例

指标类型：

次要指标

Outcome：

Proportion of patients able to walk >= 10 meters with assistance within 48 hours after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后股四头肌、踝背屈肌、踝跖屈肌肌力

指标类型：

次要指标

Outcome：

Postoperative muscle strength of the quadriceps, ankle dorsiflexors, and ankle plantar flexors

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者满意度评分

指标类型：

次要指标

Outcome：

Patient satisfaction score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后48h内不良反应

指标类型：

次要指标

Outcome：

Adverse reactions within 48 hours after surgery

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 80 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）：

随机化序列由不参与患者招募与临床操作的独立统计学家使用SAS软件生成，采用区组随机化方法（区组长度可变）

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

The randomization sequence was generated by an independent statistician not involved in patient recruitment and clinical operations using SAS software, with a block randomization method (variable block length).

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：

本研究采用双盲设计。 1. 对患者设盲：所有患者均被告知将接受神经阻滞镇痛，但不知晓具体的阻滞组合方案（FICB+IPACK或单纯FICB）。 2. 对结局评估者设盲：负责术后疼痛评分（VAS）、肌力评估、功能康复指标（屈膝角度、下地行走）记录及数据收集的研究人员，对患者分组情况不知情。 3. 对数据分析者设盲：进行统计分析的人员在分析完成前不知晓组别标识（数据以A组/B组代替）。 4. 盲法的实施与保持：神经阻滞药物（罗哌卡因/生理盐水）由不参与研究的药房或麻醉护士统一配制，并使用外观、标签完全相同的注射器封装。所有参与阻滞操作的麻醉医生不参与术后评估。在主要分析完成前，盲态不予揭破。

Blinding：

This study employed a double-blind design. 1. Patient Blinding: All patients were informed they would receive nerve block analgesia but were unaware of the specific block combination (FICB+IPACK or FICB alone). 2. Outcome Assessor Blinding:Researchers responsible for recording postoperative outcomes—including pain scores (VAS), muscle strength assessments, functional recovery measures (knee flexion angle, ambulation)—and data collection were kept unaware of patient group assignments. 3. Data Analyst Blinding:Statisticians performing the data analysis were blinded to group identifiers (data were labeled as Group A/Group B) until the primary analysis was completed. 4. Implementation and Maintenance of Blinding:The study medications (ropivacaine/normal saline) for the blocks were prepared by an independent pharmacy or anesthesia nurse not involved in the study and dispensed in identical, identically labeled syringes. All anesthesiologists performing the blocks did not participate in postoperative assessments. The blinding was maintained until the completion of the primary analysis.

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

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）：

本研究的个体参与者数据（IPD）不对外公开共享。原始数据包含患者的详细医疗信息，即使经过去标识化处理，仍存在潜在的重新识别风险。出于对参与者隐私和数据安全的严格保护，以及遵循本研究机构数据管理政策，数据仅限研究团队成员在遵守保密协议的前提下，用于本项目预设的统计分析。研究方案、统计分析计划等辅助性文件可根据合理请求，通过联系通讯作者获取。

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

No. Individual participant data (IPD) from this study will not be made publicly available. The data contain detailed clinical information, and even after de-identification, there remains a risk of participant re-identification. To uphold our strict commitment to participant privacy and data security, and in compliance with our institutional data governance policies, the data will be accessible only to the immediate research team for the purposes of pre-specified analyses outlined in the protocol. The study protocol, statistical analysis plan, and other supporting documents may be made available upon reasonable request to the corresponding author.

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：

本研究采用标准化的数据采集和管理流程，以确保数据的质量、安全与合规。 1. 数据采集工具：使用根据研究方案专门设计的纸质病例记录表（CRF）。CRF涵盖了所有研究访视点（术前、术中、术后6/12/24/48小时）需收集的数据，包括人口学资料、生命体征、神经阻滞操作记录、VAS疼痛评分、膝关节功能指标、肌力评估、PCIA用药详情及不良事件等。 2. 数据管理系统：采用基于互联网的临床研究电子数据采集（EDC）系统进行数据管理。本研究使用 ResMan系统作为EDC平台。 数据录入：由经过培训的研究协调员将纸质CRF数据双人独立录入ResMan系统。 数据质控：系统内置逻辑核查与值域核查功能。数据管理员定期审查数据，对存疑条目发出质询，并由原始研究者进行核查与确认。所有数据修改均在系统中留有审计轨迹。 数据安全：电子数据存储于安全服务器，通过用户名、密码及角色权限进行访问控制。所有研究相关纸质文件（包括已签名的知情同意书和原始CRF）均存放于带锁的文件柜中，仅授权人员可接触。 3. 数据保管：所有最终数据由淄博市中医医院统一保管，并遵循国家相关法律法规及机构数据管理政策。

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

A standardized data collection and management process was implemented to ensure data quality, security, and compliance. 1. Data Collection Tool: A paper-based Case Report Form (CRF) was specifically designed according to the study protocol. The CRF captured all required data at each study visit (preoperative, intraoperative, postoperative 6/12/24/48 hours), including demographics, vital signs, nerve block procedure details, VAS pain scores, knee function metrics, muscle strength assessments, PCIA usage, and adverse events. 2. Data Management System: A web-based Electronic Data Capture (EDC) system was used for data management. This study employed the ResMan platform as the EDC system. Data Entry: Trained study coordinators performed double data entry from paper CRFs into the ResMan system. Data Quality Control: The system featured built-in logic and range checks. Data managers conducted periodic reviews, issuing queries for questionable entries, which were then resolved by the original investigators. All data modifications were tracked via an audit trail. Data Security: Electronic data were stored on secure servers with access controlled via usernames, passwords, and role-based permissions. All study-related paper documents (including signed informed consent forms and original CRFs) were stored in locked cabinets accessible only to authorized personnel. 3. Data Custodianship: All final study data are held by Zibo Traditional Chinese Medicine Hospital in accordance with national regulations and institutional data management policies.

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：

  2026-01-20 15:43:16