ChiCTR2600126498 版本V1.0 版本创建时间2026/06/10 09:13:53 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：

 ChiCTR2600126498 

最近更新日期：

Date of Last Refreshed on：

 2026-06-10 09:13:46 

注册时间：

Date of Registration：

 2026-06-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

布比卡因脂质体注射液联合布比卡因在老年全膝关节置换术术后镇痛的剂量探索

Public title：

Dose Exploration of Liposomal Bupivacaine Injection Combined with Bupivacaine for Postoperative Analgesia in Elderly Patients Undergoing Total Knee Arthroplasty

注册题目简写：

English Acronym：

研究课题的正式科学名称：

布比卡因脂质体注射液联合布比卡因在老年全膝关节置换术术后镇痛的剂量探索

Scientific title：

Dose Exploration of Liposomal Bupivacaine Injection Combined with Bupivacaine for Postoperative Analgesia in Elderly Patients Undergoing 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：

刘文平 

研究负责人：

刘文平 

Applicant：

Wenping Liu 

Study leader：

Wenping Liu 

申请注册联系人电话：

Applicant telephone：

 +86 180 3178 3173

研究负责人电话：

Study leader's
telephone：

+86 180 3178 3173

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：

 a18031783173@163.com

研究负责人电子邮件：

Study leader's E-mail：

 a18031783173@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：

中国河北省沧州市运河区黄河西路31号

研究负责人通讯地址：

中国河北省沧州市运河区黄河西路31号

Applicant address：

31 Huanghe West Road, Yunhe District, Cangzhou, Hebei, China

Study leader's address：

31 Huanghe West Road, Yunhe District, Cangzhou, Hebei, China

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：

河北省沧州中西医结合医院

Applicant's institution：

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

研究负责人所在单位：

河北省沧州中西医结合医院

Affiliation of the Leader：

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

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：

 CZX2026-KY018-02

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：

河北省沧州中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-26 00:00:00

伦理委员会联系人：

董庆敏

Contact Name of the ethic committee：

Qingmin Dong

伦理委员会联系地址：

中国河北省沧州市运河区黄河西路31号

Contact Address of the ethic committee：

31 Huanghe West Road, Yunhe District, Cangzhou, Hebei, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 317 207 8151

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：

河北省沧州中西医结合医院

Primary sponsor：

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

研究实施负责（组长）单位地址：

中国河北省沧州市运河区黄河西路31号

Primary sponsor's address：

31 Huanghe West Road, Yunhe District, Cangzhou, Hebei, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北

市(区县)：

沧州

Country：

China

Province：

Hebei

City：

Changzhou

单位(医院)：

河北省沧州中西医结合医院

具体地址：

中国河北省沧州市运河区黄河西路31号

Institution
hospital：

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

Address：

31 Huanghe West Road, Yunhe District, Cangzhou, Hebei, China

经费或物资来源：

自筹

Source(s) of funding：

Self-raised funds

研究疾病：

膝骨性关节炎  

Target disease：

Knee Osteoarthritis

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

膝关节置换术术后早期活动在患者护理中尤为重要，其中早期活动可能带来的好处，包括减少深静脉血栓和肺栓塞等并发症，对肌肉骨骼健康的积极影响，有助于预防术后肌肉萎缩和关节僵硬。因此寻找能够实现患者早期活动并确保有效围术期疼痛管理的区域麻醉技术至关重要。多模式镇痛理念下应谨慎避免局部麻醉剂全身毒性，尤其是老年和虚弱患者。相关研究应特别关注区域麻醉技术的浓度和剂量。尽管已有报道指出，10mlLB收肌管阻滞能获得不错的镇痛效果，但超声引导下收肌管阻滞的最小有效体积（MEV）仍不清楚。确定MEV对于防止不必要的高剂量给药至关重要。此外，当对同一患者进行多处阻滞时，了解MEV可以在确保治疗成功的同时不牺牲其安全性。因此，本研究为了确定超声引导下布比卡因脂质体用于收肌管阻滞对老年患者全膝关节置换术术后完善镇痛的同时避免使用过多的局麻药，从而确定最低有效体积（minimum effective volume, MEV），具有重要的临床意义。本研究采用有偏硬币设计（biased coin design, BCD）序贯法确定超声引导下0.665%布比卡因脂质体注射液用于收肌管阻滞对老年患者全膝关节置换术术后镇痛的90%MEV（MEV90）。  

Objectives of Study：

Early mobilization after total knee arthroplasty is particularly important in patient care. Its benefits include reducing complications such as deep vein thrombosis and pulmonary embolism, exerting positive effects on musculoskeletal health, and helping prevent postoperative muscle atrophy and joint stiffness. Therefore, it is critical to identify regional anesthesia techniques that enable early patient mobilization and ensure effective perioperative pain management. Under the concept of multimodal analgesia, systemic toxicity caused by local anesthetics should be carefully avoided, especially in elderly and frail patients. Relevant studies need to pay special attention to the concentration and dosage of regional anesthetic techniques. Although it has been reported that adductor canal block with 10 mL of local anesthetic can achieve favorable analgesic effects, the minimum effective volume (MEV) of ultrasound-guided adductor canal block remains unclear. Determining the MEV is essential to prevent unnecessary high-dose administration. In addition, when multiple nerve blocks are performed on the same patient, knowledge of the MEV helps guarantee therapeutic efficacy without compromising safety. Accordingly, this study aims to determine the minimum effective volume (MEV) of liposomal bupivacaine for ultrasound-guided adductor canal block in elderly patients undergoing total knee arthroplasty. This volume can provide adequate postoperative analgesia while avoiding excessive use of local anesthetics, which is of great clinical significance. A biased coin design (BCD) sequential method was adopted in this study to determine the 90% minimum effective volume (MEV90) of 0.665% liposomal bupivacaine injection for ultrasound-guided adductor canal block in elderly patients for postoperative analgesia after 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.年龄在60岁-80岁； 2.拟于择期全身麻醉下行单侧全膝关节置换手术（TKA）； 3.美国麻醉医师协会（ASA）I-III级的患者； 4.体重指数（BMI）18-25 kg/m2。

Inclusion criteria

1. Aged between 60 and 80 years old; 2. Scheduled to undergo unilateral total knee arthroplasty (TKA) under general anesthesia; 3. Patients classified as American Society of Anesthesiologists (ASA) physical status I to III; 4. Body Mass Index (BMI) ranging from 18 to 25 kg/m2.

排除标准：

1.既往1年内有对侧全膝关节置换术史或考虑进行双侧全膝关节置换术的患者； 2.患肢同侧收肌管、股神经穿刺部位感染畸形或合并其他神经病变； 3.术前合并精神系统疾病、认知功能障碍、语言障碍等无法交流的患者； 4.需要慢性镇痛治疗疾病或阿片类药物成瘾患者； 5.术前存在肝肾功能、电解质及凝血功能明显异常活动性或既往复发消化道溃疡、出血或冠心病患者； 6.对围术期应用药物过敏、超敏、不耐受或禁忌症的患者； 7.二次手术或急诊手术； 8.其他任何研究者认为不合适参与本研究的患者。

Exclusion criteria：

1. Patients who have a history of contralateral total knee arthroplasty within the past year or are scheduled for bilateral total knee arthroplasty; 2. Patients with infection, deformity at the adductor canal or femoral nerve puncture site of the affected limb on the ipsilateral side, or combined with other neurological disorders; 3. Patients with preoperative mental illnesses, cognitive dysfunction, language disorders or other conditions that result in impaired communication ability; 4. Patients with diseases requiring chronic analgesic treatment or opioid addiction; 5. Patients with significant preoperative abnormalities in liver and renal function, electrolytes and coagulation function, active or recurrent peptic ulcers, gastrointestinal bleeding or coronary heart disease; 6. Patients with allergy, hypersensitivity, intolerance or contraindications to medications used during the perioperative period; 7. Secondary surgery or emergency surgery cases; 8. Any other patients deemed ineligible for participation in this study by the investigators.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2026-08-28 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：

超声引导收肌管阻滞（0.665%布比卡因脂质体（LB）+0.2%布比卡因5ml），体积动态调整（初始体积10ml ，体积梯度2 ml，即下一位患者LB的体积取决于上一位患者的阻滞结果，镇痛成功后以11%概率降低2 ml，89%概率维持原体积；失败则增加2 ml）

干预措施代码：

Intervention：

Ultrasound-guided adductor canal block with 5 mL mixture containing 0.665% liposomal bupivacaine (LB) plus 0.2% bupivacaine, with adaptive volume adjustment: the initial injection volume is 10 mL and the incremental/decremental volume gradient is 2 mL. Specifically, the LB volume administered to the subsequent patient is determined by the block efficacy outcome of the prior patient. In cases of successful analgesia, the volume is reduced by 2 mL at an 11% probability and kept unchanged at an 89% probability; in the event of block failure, the volume is increased by 2 mL.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

 沧州 

Country：

China

Province：

Hebei

City：

Cangzhou

单位(医院)：

 河北省沧州中西医结合医院 

单位级别：

 三甲 

Institution
hospital：

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

静息疼痛评分(NRS)及镇痛泵有效按压次数

指标类型：

主要指标

Outcome：

Resting pain score (NRS) and effective compression times of patient-controlled analgesia (PCA) pump

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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 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）：

无

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

None

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：

Blinding：

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）：

文章见刊后，采用临床试验公共管理平台http://www.medresman.org.cn/login.aspx 共享数据

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

After the article was published, the clinical trial public management platform was adopted http://www.medresman.org.cn/login.aspx Share data.

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：

研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍比对，电子数据文件分类保存，并有多个备份保存，防止破坏。

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

Based on the original observation records of the subjects, the researchers timely, completely, correctly, and clearly loaded the data into the case report form. The corresponding database system was used for dual person and dual machine input, and then the database was compared twice. The electronic data files were classified and saved with multiple backups to prevent damage.

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：

  2026-06-10 09:13:46