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The influence of preoperative buccal acupuncture intervention on postoperative pain and endocannabinoid receptors in total knee arthroplasty

注册号：

Registration number：

ITMCTR2025000537

最近更新日期：

Date of Last Refreshed on：

2025-03-17

注册时间：

Date of Registration：

2025-03-17

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

术前颊针干预对全膝关节置换术术后疼痛及内源性大麻素受体的影响

Public title：

The influence of preoperative buccal acupuncture intervention on postoperative pain and endocannabinoid receptors in total knee arthroplasty

注册题目简写：

术前颊针干预对全膝关节置换术术后疼痛及内源性大麻素受体的影响

English Acronym：

The influence of preoperative buccal acupuncture intervention on postoperative pain and endocannabinoid receptors in total knee arthroplasty

研究课题的正式科学名称：

术前颊针干预对全膝关节置换术术后疼痛及内源性大麻素受体的影响

Scientific title：

The influence of preoperative buccal acupuncture intervention on postoperative pain and endocannabinoid receptors in total knee arthroplasty

研究课题的正式科学名称简写：

术前颊针干预对全膝关节置换术术后疼痛及内源性大麻素受体的影响

Scientific title acronym：

The influence of preoperative buccal acupuncture intervention on postoperative pain and endocannabinoid receptors in 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：

王万荣

研究负责人：

沈理

Applicant：

wanrong wang

Study leader：

Shen Li

申请注册联系人电话：

Applicant telephone：

+86 182 9565 2557

研究负责人电话：

Study leader's telephone：

+86 18246090494

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：

1084243932@qq.com

研究负责人电子邮件：

Study leader's E-mail：

957566961@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

宁夏回族自治区金凤区正源北街301

研究负责人通讯地址：

宁夏回族自治区金凤区正源北街301

Applicant address：

301 Zhengyuan North Street Jinfeng District Ningxia Hui Autonomous Region

Study leader's address：

301 Zhengyuan North Street Jinfeng District Ningxia Hui Autonomous Region

申请注册联系人邮政编码：

Applicant postcode：

750002

研究负责人邮政编码：

Study leader's postcode：

750002

申请人所在单位：

宁夏回族自治区人民医院

Applicant's institution：

Ningxia Hui Autonomous Region People's Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

伦理[2025]-NZR-038

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

宁夏回族自治区人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Ningxia Hui Autonomous Region People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/5 0:00:00

伦理委员会联系人：

梁培军

Contact Name of the ethic committee：

Peijun Liang

伦理委员会联系地址：

宁夏回族自治区金凤区正源北街301

Contact Address of the ethic committee：

301 Zhengyuan North Street Jinfeng District Ningxia Hui Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 182 9501 9369

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kjc5920152@126.com

研究实施负责（组长）单位：

宁夏回族自治区人民医院

Primary sponsor：

Ningxia Hui Autonomous Region People's Hospital

研究实施负责（组长）单位地址：

宁夏回族自治区金凤区正源北街301

Primary sponsor's address：

301 Zhengyuan North Street Jinfeng District Ningxia Hui Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

宁夏回族自治区

市(区县)：

银川

Country：

China

Province：

Ningxia Hui Autonomous Region

City：

Yinchuan

单位(医院)：

宁夏回族自治区人民医院

具体地址：

宁夏回族自治区金凤区正源北街301

Institution
hospital：

Ningxia Hui Autonomous Region People's Hospital

Address：

301 Zhengyuan North Street Jinfeng District Ningxia Hui Autonomous Region

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

膝骨性关节炎

研究疾病代码：

Target disease：

Knee osteoarthritis

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

本项研究旨在探究术前颊针针刺膝穴和腘窝穴干预是否用来缓解TKA术后膝关节后方疼痛，并探索颊针的镇痛机制是否与内源性大麻素受体（CB1R、CB2R和GPR55）相关。

Objectives of Study：

The aim of this study was to investigate whether preoperative buccal acupuncture knee and popliteal fossa intervention can be used to relieve posterior knee pain after TKA and to explore whether the analgesic mechanism of buccal acupuncture is related to endocannabinoid receptors (CB1R CB2R and GPR55).

药物成份或治疗方案详述：

所有纳入本研究的患者皆由一名高年资主治医生管理。所有患者术前被要求常规禁饮禁食，并禁用与治疗无关的药物。患者首先在麻醉准备间开放上肢静脉通路，术前1小时进行相应实验措施：①试验组患者：分别于膝穴、腘窝穴两个穴位处进行定位治疗，留针30分钟；②采用非特异性穴位皮肤穿透假针灸即塑料导管可伸缩假针于传统穴位旁开0.5-5cm进行操作，保持操作一致性。干预前、后患者NRS疼痛评分、膝关活动度对颊针干预效果进行标准化评估，患者NRS疼痛评分减少50%，ROM评分增加视为颊针干预有效。治疗前后依照 CRF表格收集所需要资料。随后进行超声引导下行股神经阻滞置管操作，置管成功后注射浓度为0.375%的盐酸罗哌卡因20mL。所有患者麻醉方式皆采用L2-L3或L3-L4间隙穿刺的等比重腰麻（0.5%布比卡因+0.05mg芬太尼共3ml）。以上操作皆由经验丰富的麻醉医生进行。术后以0.2%罗哌卡因(300mg罗哌卡因+生理盐水150ml)，输注速度为5ml/h。手术结束出手术室时连接镇痛泵。

Description for medicine or protocol of treatment in detail：

All patients included in this study were managed by a senior attending physician. All patients were asked to routinely abstain from eating and drinking and to prohibit drugs unrelated to treatment. The patients first opened the venous access of the upper limbs in the anaesthesia preparation room and the corresponding experimental measures were carried out 1 hour before the operation: (1) the patients in the experimental group: the two acupuncture points of the knee and popliteal fossa were respectively positioned and the needles were left for 30 minutes; (2) Pseudo-acupuncture is used to penetrate the skin of non-specific acupuncture points that is plastic catheters can be retracted with false needles to open 0.5-5cm next to traditional acupuncture points to maintain the consistency of operation. Before and after the intervention the NRS pain score and knee range of motion of patients were standardised to evaluate the effect of buccal acupuncture intervention and the NRS pain score of patients was reduced by 50% and the increase of ROM score was regarded as the effect of buccal acupuncture intervention. Before and after treatment the required information should be collected according to the CRF form. Subsequently ultrasound-guided femoral nerve block catheterisation was performed and 20mL of ropivacaine hydrochloride at a concentration of 0.375% was injected after successful catheterisation. All patients were anaesthetised with L2-L3 or L3-L4 space puncture with isobarometric spinal anaesthesia (0.5% bupivacaine + 0.05mg fentanyl a total of 3ml). All of the above procedures are performed by experienced anaesthetists. Postoperatively 0.2% ropivacaine (300 mg ropivacaine + 150 ml of normal saline) was infused at a rate of 5 ml/h. An analgesic pump is connected when you leave the operating room at the end of the operation.

纳入标准：

1)年龄40-70岁，性别不限；2)美国麻醉医师学会（ASA）分级为Ⅰ~Ⅲ级；3)诊断为骨性关节炎，拟在腰麻下行初次选择性单侧全膝关节置换术（TKA）4)无颊针、股神经、腰麻禁忌症；5)无局麻药过敏；6)能配合理解；7)获得知情同意。

Inclusion criteria

1) Age 40-70 years old gender is not limited; 2) American College of Anesthesiologists (ASA) classification I.~III.; 3) Diagnosed with osteoarthritis it is planned to undergo primary selective unilateral total knee arthroplasty (TKA) under spinal anaesthesia; 4) There are no contraindications to buccal needle femoral nerve and spinal anaesthesia; 5) No local anaesthetic allergy; 6) Able to cooperate and understand; 7) Obtain informed consent.

排除标准：

1）身体质量指数（BMI）<18或>40；2）患有外周神经病；3）严重肾功能损害（需行肾脏替代治疗）；4）严重肝功能损害（Child-Pugh分级C级）；5）严重心血管疾病史（NYHA>2级）；6）主治医生或研究者认为存在其他不宜参加本研究的情况; 2.1.1.3剔除标准1)未能配合完成本研究方案所制定的治疗措施者；2)未完成临床试验全程随访者； 3)出现严重的并发症或不良反应，经研究者判定需中止实验者。

Exclusion criteria：

1) Body mass index (BMI) < 18 or >40; 2) Peripheral neuropathy; 3) severe renal impairment (requiring renal replacement therapy); 4) severe hepatic impairment (Child-Pugh grade C); 5) History of severe cardiovascular disease (NYHA > grade 2); 6) Other circumstances that the attending physician or investigator considers unsuitable to participate in this study; 2.1.1.3 Exclusion criteria: 1) Those who fail to cooperate with the completion of the treatment measures formulated in this study protocol; 2) Those who have not completed the full follow-up of clinical trials; 3) Those who have serious complications or adverse reactions and need to discontinue the experiment as determined by the investigator.

研究实施时间：

Study execute time：

从From 2025-04-01

至To      2025-09-30

征募观察对象时间：

Recruiting time：

从From 2025-04-01

至To      2025-09-15

干预措施：

Interventions：

组别：

试验组患者

样本量：

47

Group：

Patients in the experimental group

Sample size：

干预措施：

分别于膝穴、腘窝穴两个穴位处进行定位治疗，留针30分钟

干预措施代码：

Intervention：

Positioning treatment was carried out at the knee acupoint and popliteal fossa acupoint and the needle was left for 30 minutes

Intervention code：

组别：

对照组患者

样本量：

47

Group：

Patients in the control group

Sample size：

干预措施：

采用非特异性穴位皮肤穿透假针灸即塑料导管可伸缩假针于传统穴位旁开0.5-5cm进行操作，保持操作一致性

干预措施代码：

Intervention：

Non-specific acupuncture points are used to penetrate the skin through pseudo-acupuncture, that is, plastic catheters can be retracted with false needles to open 0.5-5cm next to traditional acupuncture points to maintain the consistency of operation

Intervention code：

样本总量 Total sample size ： 94

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

宁夏回族自治区

市(区县)：

银川

Country：

China

Province：

Ningxia

City：

Yinchuan

单位(医院)：

宁夏回族自治区人民医院

单位级别：

三甲医院

Institution/hospital：

Ningxia Hui Autonomous Region People's Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

TKA术后全膝关节静息、活动时NRS疼痛评分

指标类型：

主要指标

Outcome：

NRS pain score at rest and during activity of total knee after TKA

Type：

Primary indicator

测量时间点：

术后0、6、12、24、48小时

测量方法：

NRS疼痛评估法

Measure time point of outcome：

0 6 12 24 48 hours after surgery

Measure method：

NRS pain assessment

指标中文名：

颊针干预前后患者膝关活动度

指标类型：

次要指标

Outcome：

Knee range of motion of patients before and after buccal acupuncture intervention

Type：

Secondary indicator

测量时间点：

颊针干预前后

测量方法：

量角器测量

Measure time point of outcome：

Before and after buccal acupuncture intervention

Measure method：

Protractor measurements

指标中文名：

颊针干预前后患者NRS疼痛评分

指标类型：

次要指标

Outcome：

NRS pain scores of patients before and after buccal acupuncture intervention

Type：

Secondary indicator

测量时间点：

颊针干预前后

测量方法：

NRS疼痛评估法

Measure time point of outcome：

Before and after buccal acupuncture intervention

Measure method：

NRS pain assessment

指标中文名：

TKA术后膝关节后方静息、活动时NRS疼痛评分

指标类型：

主要指标

Outcome：

NRS pain score at rest and during activity at the back of the knee after TKA

Type：

Primary indicator

测量时间点：

术后0、6、12、24、48小时

测量方法：

NRS疼痛评估法

Measure time point of outcome：

0 6 12 24 48 hours after surgery

Measure method：

NRS pain assessment

指标中文名：

膝关节滑膜内源性大麻素受体(CB1R、CB2R和GPR55)的检测

指标类型：

次要指标

Outcome：

Detection of endocannabinoid receptors (CB1R, CB2R, and GPR55) in the synovial membrane of the knee

Type：

Secondary indicator

测量时间点：

术中取样，术后统一保存测量

测量方法：

蛋白印迹法

Measure time point of outcome：

Intraoperative sampling was taken, and measurements were stored uniformly after surgery.

Measure method：

Western blotting

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

膝关节滑膜

组织：

膝关节

Sample Name：

Synovium of the knee

Tissue：

knee

人体标本去向

使用后销毁

说明

3年

Fate of sample 

Destruction after use

Note：

three years

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 40 岁
Min age years
最大 70 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由宁夏人民医院住院医师马晨辉使用随机化软件产生随机序列，自2025年4月1日开始招募

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

The random sequence was generated by Ma Chenhui a resident physician at Ningxia People's Hospital using randomization software. Recruitment began on April 1 2025.

盲法：

只有颊针操作人员知道分组，患者、骨科医生、麻醉医师及护士不知道分组，术后评价由对分组不知情的研究员进行。

Blinding：

Only the buccal needle operator is aware of the grouping the patient the orthopedic surgeon the anesthesiologist and the nurse are not aware of the grouping and the postoperative evaluation is performed by a researcher who is blinded to the group.

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）：

http://www.medresman.org.cn/uc/index.aspx

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

http://www.medresman.org.cn/uc/index.aspx

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：

CRF表格

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

Clinical Record Form

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

暂未确定

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

Not yet

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