ChiCTR2600126246 版本V1.0 版本创建时间2026/06/05 11:48:13 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：

 ChiCTR2600126246 

最近更新日期：

Date of Last Refreshed on：

 2026-06-05 11:48:04 

注册时间：

Date of Registration：

 2026-06-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声引导下上后锯肌肋间平面阻滞与肌间沟阻滞用于肩关节镜手术术后镇痛的比较：一项随机对照、非劣效性研究

Public title：

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block versus Interscalene Block for Postoperative Analgesia after Arthroscopic Shoulder Surgery: A Randomized Controlled Noninferiority Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声引导下上后锯肌肋间平面阻滞与肌间沟阻滞用于肩关节镜手术术后镇痛的比较：一项随机对照、非劣效性研究

Scientific title：

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block versus Interscalene Block for Postoperative Analgesia after Arthroscopic Shoulder Surgery: A Randomized Controlled Noninferiority 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：

柳立伟 

研究负责人：

柳立伟 

Applicant：

Liwei Liu 

Study leader：

Liwei Liu 

申请注册联系人电话：

Applicant telephone：

 +86 185 1591 6310

研究负责人电话：

Study leader's
telephone：

+86 10 8083 6874

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：

 liuliwei0212@163.com

研究负责人电子邮件：

Study leader's E-mail：

 liuliwei0212@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：

北京市西城区永安路95号

研究负责人通讯地址：

北京市西城区永安路95号

Applicant address：

No. 95 Yong’an Road, Xicheng District, Beijing, China

Study leader's address：

No.95 Yongan Road,Xicheng District,Beijing,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：

首都医科大学附属北京友谊医院

Applicant's institution：

Beijing Friendship Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京友谊医院

Affiliation of the Leader：

Beijing Friendship Hospital ,Capital Medical University

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：

 2026-P2-175-01

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：

首都医科大学附属北京友谊医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of Beijing Friendship Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-21 00:00:00

伦理委员会联系人：

李悦

Contact Name of the ethic committee：

Li Yue

伦理委员会联系地址：

北京市西城区永安路95号

Contact Address of the ethic committee：

No.95 Yongan Road,Xicheng District,Beijing,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6313 9006

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 13661202501@163.com

研究实施负责（组长）单位：

首都医科大学附属北京友谊医院

Primary sponsor：

Beijing Friendship Hospital ,Capital Medical University

研究实施负责（组长）单位地址：

北京市西城区永安路95号

Primary sponsor's address：

No.95 Yongan Road,Xicheng District,Beijing,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)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京友谊医院

具体地址：

北京市西城区永安路95号

Institution
hospital：

Beijing Friendship Hospital ,Capital Medical University

Address：

No.95 Yongan Road,Xicheng District,Beijing,China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected research project (self-funded)

研究疾病：

肩关节疾病；肩关节损伤；肩袖损伤  

Target disease：

Shoulder disorders ; Shoulder injuries ; Rotator cuff injuries

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：

随机平行对照 

Study design：

Parallel 

研究目的：

评价超声引导下上后锯肌肋间平面阻滞在术后24小时的镇痛效果是否不劣于肌间沟阻滞  

Objectives of Study：

To evaluate whether the analgesic effect of ultrasound-guided serratus posterior superior intercostal plane block at 24 hours postoperatively is noninferior to that of interscalene block in patients undergoing arthroscopic shoulder surgery

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. 性别不限，年龄 18-80 岁，ASA I-III 级； 2. BMI 18-35 kg/m^2； 3. 择期行肩关节镜手术（如肩袖修复、盂唇切除、肩峰成形）； 4. 患者理解并签署知情同意书。

Inclusion criteria

1. Any gender, aged 18–80 years, ASA physical status I–III; 2. BMI 18–35 kg/m^2; 3. Scheduled for elective arthroscopic shoulder surgery (e.g., rotator cuff repair, labral debridement, acromioplasty); 4. The patient understands and signs the informed consent form.

排除标准：

1.既往患有严重肺部疾病（如慢性阻塞性肺疾病、膈神经损伤、肺手术史）； 2.穿刺部位存在感染、畸形或既往手术史，或肢体存在神经功能障碍； 3.对局麻药过敏； 4.长期服用阿片类药物； 5.凝血功能障碍、肝肾功能衰竭、妊娠或哺乳期患者； 6.存在精神障碍等无法配合NRS评估者； 7.接受翻修、冲洗或清创手术者； 8.拒绝签署知情同意书者；

Exclusion criteria：

1.History of severe pulmonary disease (e.g., chronic obstructive pulmonary disease, phrenic nerve injury, history of lung surgery); 2.Infection, deformity, or previous surgical history at the puncture site, or pre-existing neurological dysfunction of the affected limb; 3.Allergy to local anesthetics; 4.Long-term opioid use; 5.Patients with coagulation disorders, hepatic or renal failure, or those who were pregnant or breastfeeding; 6.Patients with psychiatric disorders or other conditions that could interfere with cooperation with NRS assessment; 7.Patients undergoing revision, irrigation, or debridement surgery; 8.Patients who refused to sign the informed consent form;

研究实施时间：

Study execute time：

从 From 2026-06-15 00:00:00至 To 2028-06-14 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

ISB组

样本量：

 44

Group：

Group ISB

Sample size：

干预措施：

肌间沟阻滞

干预措施代码：

Intervention：

Interscalene Block

Intervention code：

组别：

SPSIPB组

样本量：

 44

Group：

Group SPSIPB

Sample size：

干预措施：

上后锯肌肋间平面阻滞

干预措施代码：

Intervention：

Serratus Posterior Superior Intercostal Plane Block

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属北京友谊医院 

单位级别：

 三级甲等 

Institution
hospital：

Beijing Friendship Hospital ,Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后24小时静息NRS疼痛评分

指标类型：

主要指标

Outcome：

Pain Numerical Rating Scale

Type：

Primary indicator

测量时间点：

术后24小时静息状态下

测量方法：

采用疼痛数字评分法（NRS，0-10分）对术后疼痛进行评估。0分为无痛，1-3分为轻度疼痛，4-6分为中度疼痛，7-10分为重度疼痛。

Measure time point of outcome：

at rest at 24 hours after surgery

Measure method：

Postoperative pain was assessed using the Numerical Rating Scale (NRS, 0–10). A score of 0 indicated no pain, 1–3 indicated mild pain, 4–6 indicated moderate pain, and 7–10 indicated severe pain.

指标中文名：

住院天数

指标类型：

次要指标

Outcome：

Length of hospital stay

Type：

Secondary indicator

测量时间点：

从手术日至出院日的时间间隔（天数）

测量方法：

住院天数定义为从手术日至出院日的时间间隔（天数）。

Measure time point of outcome：

The time interval (in days) from the day of surgery to the day of discharge.

Measure method：

Length of hospital stay was defined as the time interval (in days) from the date of surgery to the date of hospital discharge.

指标中文名：

神经阻滞相关功能恢复指标

指标类型：

次要指标

Outcome：

Nerve block–related functional recovery indicators

Type：

Secondary indicator

测量时间点：

术后48h内

测量方法：

神经阻滞相关功能恢复指标（感觉及运动阻滞时间）以阻滞完成为起点。感觉功能采用酒精棉签冷感4点数字量表评估，感觉阻滞时间定义为感觉恢复至对侧一致的时间；运动功能采用改良MRC肌力分级（0–5级）评估，以基线为对照，运动阻滞时间定义为肌力恢复至5级的时间。

Measure time point of outcome：

Within 48 hours after surgery

Measure method：

Block-related functional recovery outcomes (sensory and motor block durations) were calculated from the time of block completion. Sensory function was assessed using a 4-point cold sensation scale with alcohol swabs, and sensory block duration was defined as the time to recovery of sensation comparable to the contralateral side. Motor function was evaluated using the modified Medical Research Council (MRC) muscle strength grading scale (0–5), with baseline values as reference; motor block durati

指标中文名：

镇痛持续时间

指标类型：

次要指标

Outcome：

Duration of analgesia

Type：

Secondary indicator

测量时间点：

术后48h内

测量方法：

镇痛持续时间（即首次补救镇痛时间）定义为自神经阻滞完成至患者首次因手术部位疼痛需要补救镇痛，并首次按压患者自控镇痛泵（PCA）的时间间隔。由PCA设备历史记录中首次有效按压时间获取，并以神经阻滞完成时间作为起始时间进行计算。

Measure time point of outcome：

Within 48 hours after surgery

Measure method：

Duration of analgesia (i.e., time to first rescue analgesia) was defined as the time interval from completion of the nerve block to the first occurrence of postoperative surgical-site pain requiring rescue analgesia, corresponding to the patient’s first press of the patient-controlled analgesia (PCA) device. This outcome was determined using the PCA device history log to identify the time of the first effective demand, with the time of nerve block completion used as the starting point for calcul

指标中文名：

基线资料及术中变量

指标类型：

次要指标

Outcome：

Baseline characteristics and intraoperative variables

Type：

Secondary indicator

测量时间点：

术前和术中

测量方法：

术前获取基线人口学资料身高、体重、性别、年龄、ASA分级等；术中记录平均动脉压、平均心率、麻醉时间、手术时间、术中舒芬太尼和瑞芬太尼用量等。

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Baseline demographic data, including height, weight, sex, age, and American Society of Anesthesiologists (ASA) physical status classification, were collected preoperatively. Intraoperative data, including mean arterial pressure, mean heart rate, duration of anesthesia, surgical duration, and intraoperative consumption of sufentanil and remifentanil, were recorded during surgery.

指标中文名：

阻滞前、阻滞后30min、PACU（术后30min）的膈肌麻痹发生率及严重程度（完全/部分/无）

指标类型：

次要指标

Outcome：

Incidence and severity (complete/partial/none) of hemidiaphragmatic paralysis before block, 30 minutes after block, and in the post-anesthesia care unit (PACU, 30 minutes postoperatively).

Type：

Secondary indicator

测量时间点：

阻滞前、阻滞后30min、PACU

测量方法：

用超声测量阻滞侧膈肌移动度，深呼吸时测量膈肌运动3次，取平均值。完全性膈肌麻痹：膈肌运动减少>75%或出现矛盾性膈肌运动，部分性膈肌麻痹：膈肌运动减少25%~75%，无明显膈肌麻痹：膈肌运动减少<25%。

Measure time point of outcome：

Before block, 30 minutes after block, and in the PACU

Measure method：

Diaphragmatic excursion on the blocked side was measured using ultrasonography. Diaphragmatic movement during deep breathing was measured three times, and the mean value was recorded. Complete hemidiaphragmatic paralysis was defined as a reduction in diaphragmatic excursion of >75% or the presence of paradoxical diaphragmatic movement. Partial hemidiaphragmatic paralysis was defined as a reduction in diaphragmatic excursion of 25%–75%, while no apparent hemidiaphragmatic paralysis was defined as

指标中文名：

术后镇痛药物

指标类型：

次要指标

Outcome：

Postoperative analgesic medications

Type：

Secondary indicator

测量时间点：

术后24、48h

测量方法：

统计术后24、48h阿片类药物用量（以静脉吗啡当量计算）和非阿片类药物用量（术后常规镇痛药氟比洛芬酯和补救镇痛药曲马多等）。

Measure time point of outcome：

24 and 48 hours postoperatively

Measure method：

Total opioid consumption within 24 and 48 h postoperatively was recorded and standardized as intravenous morphine equivalents (IMEs). Non-opioid analgesic consumption, including routinely administered postoperative analgesics (e.g., flurbiprofen axetil) and rescue analgesics (e.g., tramadol), was also documented.

指标中文名：

术前1天，PACU（术后30min），术后2、6、12、24h、48h静息和动态NRS评分

指标类型：

次要指标

Outcome：

Preoperative day 1, in the post-anesthesia care unit (PACU, 30 minutes postoperatively), and at 2, 6, 12, 24, and 48 hours postoperatively, including both resting and dynamic NRS scores

Type：

Secondary indicator

测量时间点：

术前1天，PACU（术后30min），术后2、6、12、24h、48h

测量方法：

采用疼痛数字评分法（NRS，0-10分）对术后疼痛进行评估。0分为无痛，1-3分为轻度疼痛，4-6分为中度疼痛，7-10分为重度疼痛。

Measure time point of outcome：

Preoperative day 1, PACU, and 2, 6, 12, 24, and 48 hours postoperatively

Measure method：

Postoperative pain was assessed using the Numerical Rating Scale (NRS, 0–10). A score of 0 indicated no pain, 1–3 indicated mild pain, 4–6 indicated moderate pain, and 7–10 indicated severe pain.

指标中文名：

患肢MRC肌力评分

指标类型：

次要指标

Outcome：

MRC muscle strength score of the affected limb

Type：

Secondary indicator

测量时间点：

术前、术后6、24、48h

测量方法：

测量术前、术后6、24、48h患肢MRC肌力评分。MRC肌力分级（0-5级）（0分=无肌肉收缩；1分=轻微收缩无关节运动；2分=可运动关节但不能克服重力；3分=可克服重力但不能抵抗阻力；4分=可克服一定阻力但略弱于正常；5分=正常肌力）。

Measure time point of outcome：

Preoperatively, and at 6, 24, and 48 hours postoperatively

Measure method：

Muscle strength of the affected limb was assessed preoperatively and at 6, 24, and 48 hours postoperatively using the Medical Research Council (MRC) grading scale. The MRC scale ranges from 0 to 5: 0 = no muscle contraction; 1 = flicker or trace contraction without joint movement; 2 = movement with elimination of gravity; 3 = movement against gravity but not against resistance; 4 = movement against resistance but weaker than normal; and 5 = normal muscle strength.

指标中文名：

恢复质量量表（QoR-15）

指标类型：

次要指标

Outcome：

Quality of Recovery-15 (QoR-15) scale

Type：

Secondary indicator

测量时间点：

术后24、48h

测量方法：

在术后24h和48h采用恢复质量量表（QoR-15）进行评估，总分0–150分，分值越高表示恢复质量越好。

Measure time point of outcome：

At 24 and 48 hours postoperatively

Measure method：

The Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery at 24 and 48 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.

指标中文名：

术后并发症

指标类型：

次要指标

Outcome：

Postoperative complications

Type：

Secondary indicator

测量时间点：

术后48h内

测量方法：

记录术后48 h内的并发症，包括全身麻醉相关并发症（如术后恶心呕吐、呼吸抑制、皮肤瘙痒、心律失常、肺部感染等）以及神经阻滞相关并发症（如气胸、血肿、感染、局部麻醉药中毒等）。

Measure time point of outcome：

Within 48 hours after surgery

Measure method：

Postoperative complications within 48 hours were recorded, including general anesthesia-related complications (such as postoperative nausea and vomiting, respiratory depression, pruritus, arrhythmia, and pulmonary infection) and nerve block-related complications (such as pneumothorax, hematoma, infection, and local anesthetic systemic toxicity).

指标中文名：

同侧完全或部分膈肌麻痹发生率

指标类型：

次要指标

Outcome：

Incidence of ipsilateral complete or partial diaphragmatic paralysis

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：

NA

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 18 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）：

由独立人员通过计算机生成随机数字。

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

Random numbers were generated by independent personnel using a computer.

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：

单盲，对评估者隐藏分组

Blinding：

Single blind study with blinded-evaluators

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）：

2028.12（研究结束后半年内），向研究者索取

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

December 2028 (within six months after study completion), upon request from the investigators.

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：

采用CRF表和EXCEL表格收集和管理数据

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

Data collection and Management by using CRF and EXCEL

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-05 11:48:04