ChiCTR2600125958 版本V1.0 版本创建时间2026/06/01 18:12:41 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：

 ChiCTR2600125958 

最近更新日期：

Date of Last Refreshed on：

 2026-06-01 18:12:23 

注册时间：

Date of Registration：

 2026-06-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

氢吗啡酮静脉自控镇痛在肩关节镜肩袖修复术后的镇痛效果及安全性分析

Public title：

Analgesic Efficacy and Safety of Hydromorphone for Patient-Controlled Intravenous Analgesia after Arthroscopic Rotator Cuff Repair of the Shoulder

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氢吗啡酮静脉自控镇痛在肩关节镜肩袖修复术后的镇痛效果及安全性分析

Scientific title：

Analgesic Efficacy and Safety of Hydromorphone for Patient-Controlled Intravenous Analgesia after Arthroscopic Rotator Cuff Repair of the Shoulder

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：

赵雨薇 

研究负责人：

祁凤灵 

Applicant：

Zhao Yuwei 

Study leader：

Qi Fengling 

申请注册联系人电话：

Applicant telephone：

 +86 15548747785

研究负责人电话：

Study leader's
telephone：

+86 472 2178609

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：

 1442472869@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 18648600458@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：

内蒙古自治区包头市昆都仑区林荫路41号

研究负责人通讯地址：

内蒙古包头市昆都仑区钢铁大街林荫路41号

Applicant address：

No. 41 Linyin Road, Kundulun District, Baotou City, Inner Mongolia Autonomous Region

Study leader's address：

41 Linyin Road, Hondlon District Iron Street, Baotou, Inner Mongolia

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：

包头医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Baotou Medical College

研究负责人所在单位：

内蒙古科技大学包头医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

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伦理审查第（06-1）号

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：

内蒙古科技大学包头医学院第一附属医院医学伦理委员会科研项目审查分委会

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-22 00:00:00

伦理委员会联系人：

奇梦怀

Contact Name of the ethic committee：

Qi MengHuai

伦理委员会联系地址：

内蒙古包头市昆都仑区钢铁大街林荫路41号

Contact Address of the ethic committee：

41 Linyin Road, Hondlon District Iron Street, Baotou, Inner Mongolia

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 472 2178313

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 1204393794@qq.com

研究实施负责（组长）单位：

内蒙古科技大学包头医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

研究实施负责（组长）单位地址：

内蒙古包头市昆都仑区钢铁大街林荫路41号

Primary sponsor's address：

41 Linyin Road, Hondlon District Iron Street, Baotou, Inner Mongolia

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

内蒙古自治区

市(区县)：

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

单位(医院)：

内蒙古科技大学包头医学院第一附属医院

具体地址：

内蒙古包头市昆都仑区钢铁大街林荫路41号

Institution
hospital：

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

Address：

41 Linyin Road, Hondlon District Iron Street, Baotou, Inner Mongolia

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-funded

研究疾病：

肩袖损伤，肩关节镜肩袖修复术后急性疼痛  

Target disease：

Target diseaseRotator Cuff Injury, Acute Postoperative Pain After Arthroscopic Rotator Cuff Repair of Shoulder

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：

1. 主要目的：比较氢吗啡酮与舒芬太尼静脉自控镇痛（PCIA）用于肩关节 镜肩袖修复术后的镇痛效果。 2. 次要目的：评估两种方案的安全性（不良反应发生率）、对患者情绪状 态的影响，以及术后早期康复相关指标  

Objectives of Study：

1.Primary Objective：To compare the analgesic efficacy of intravenous patient-controlled analgesia (PCIA) with hydromorphone versus sufentanil in patients after arthroscopic shoulder rotator cuff repair.2.Secondary Objectives：To evaluate the safety of the two regimens (incidence of adverse reactions);To assess their impact on patients' emotional status;To analyze the postoperative early rehabilitation-related indicators.

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.符合肩袖损伤诊断标准，拟择期行肩关节镜下肩袖修补术的患者，年龄 18~75 岁，性别不限；
2.ASA分级Ⅰ~Ⅱ级，无严重心、肝、肾、肺等重要脏器功能障碍；
3.意识清晰，能正常沟通，可配合完成疼痛评分、自控镇痛泵操作及术后康复训练；
4.患者及家属知情同意，自愿参与本研究，并签署知情同意书；

Inclusion criteria

1.Patients diagnosed with rotator cuff injury and scheduled for elective arthroscopic rotator cuff repair, aged 18 to 75 years, with no gender restriction; 2.ASA physical status class Ⅰ to Ⅱ, with no severe dysfunction of the heart, liver, kidney, lung or other vital organs; 3.Clear consciousness, normal communication ability, and able to cooperate with pain assessment, patient-controlled analgesia pump operation and postoperative rehabilitation training; 4.Patients and their family members have given informed consent, voluntarily participated in this study, and signed the informed consent form.

排除标准：

1.对氢吗啡酮、阿片类药物或本研究中辅助用药过敏者；
2.有阿片类药物滥用史、长期镇痛药物服用史者；
3.合并凝血功能障碍、精神疾病、认知功能障碍者；
4.患有严重心肺功能不全、肝肾功能障碍者；
5.妊娠或哺乳期女性；
6.近3个月内参与其他临床研究者；

Exclusion criteria：

1.Patients with hypersensitivity to hydromorphone, opioids, or adjuvant medications used in this study; 2.Patients with a history of opioid abuse or long-term use of analgesics; 3.Patients complicated with coagulation disorders, mental illness or cognitive dysfunction; 4.Patients with severe cardiopulmonary insufficiency or hepatic and renal dysfunction; 5.Pregnant or lactating women; 6.Patients who have participated in other clinical studies within the past 3 months.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2028-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-07-01 00:00:00

干预措施：

Interventions：

组别：

对照组（舒芬太尼组）

样本量：

 60

Group：

Control Group（Sufentanil Group）

Sample size：

干预措施：

舒芬太尼静脉自控镇痛（PCIA）

干预措施代码：

Intervention：

Sufentanil Intravenous Patient-Controlled Analgesia (PCIA)

Intervention code：

组别：

试验组（氢吗啡酮组）

样本量：

 60

Group：

Experimental Group（Hydromorphone Group）

Sample size：

干预措施：

氢吗啡酮静脉自控镇痛（PCIA）

干预措施代码：

Intervention：

Hydromorphone Intravenous Patient-Controlled Analgesia (PCIA)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 内蒙古自治区 

市(区县)：

  

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

单位(医院)：

 内蒙古科技大学包头医学院第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术中舒芬太尼、瑞芬太尼用量

指标类型：

次要指标

Outcome：

Intraoperative Sufentanil and Remifentanil Dosage

Type：

Secondary indicator

测量时间点：

术中

测量方法：

由麻醉医师于术中记录舒芬太尼、瑞芬太尼的实际使用剂量，术后从麻醉记录单中提取并统计两组患者的术中用药用量。

Measure time point of outcome：

Intraoperatively

Measure method：

Metric/method of measurement* The actual intraoperative dosage of sufentanil and remifentanil was recorded by the anesthesiologist during surgery, and the consumption of the two drugs in both groups was extracted and counted from the anesthesia records postoperatively.

指标中文名：

患者入 组时的人口学基线资料（年龄、性别、身高、体重、BMI等）

指标类型：

次要指标

Outcome：

Demographic Baseline Characteristics at Enrollment (Age, Gender, Height, Weight, BMI, etc.)

Type：

Secondary indicator

测量时间点：

术前1天

测量方法：

从医院电子病历系统调取，由经过培训的研究者记录

Measure time point of outcome：

1 day preoperatively

Measure method：

Extracted from the hospital electronic medical record system, verified and recorded by trained investigators at the time of enrollment

指标中文名：

术后首次下床时间、术后首次排气时间

指标类型：

次要指标

Outcome：

Time to First Ambulation and Time to First Flatus Postoperatively

Type：

Secondary indicator

测量时间点：

术后48小时内

测量方法：

术后48小时内，由责任护士记录患者术后首次自主下床活动的时间点，同时记录患者术后首次排气的时间点，统计并对比两组患者的上述指标。

Measure time point of outcome：

Within 48 hours postoperatively

Measure method：

Within 48 hours postoperatively, the time point of the patient's first independent ambulation and the time point of the first flatus after surgery were recorded by the responsible nurse, and the above indicators in both groups were counted and compared.

指标中文名：

血氧饱和度、心率、平均动脉压

指标类型：

主要指标

Outcome：

Blood oxygen saturation, heart rate, mean arterial pressure

Type：

Primary indicator

测量时间点：

术后2小时、6小时、12小时、24小时、48小时

测量方法：

采用床旁监护仪连续监测，记录各时间点的血氧饱和度、心率及平均动脉压数值

Measure time point of outcome：

2h, 6h, 12h, 24h, 48h postoperatively

Measure method：

Measured by bedside monitor, and the values of SpO?, HR and MAP at each time point were recorded

指标中文名：

术后住院天数

指标类型：

次要指标

Outcome：

Postoperative Hospital Length of Stay

Type：

Secondary indicator

测量时间点：

患者出院时

测量方法：

从医院住院信息系统中提取患者的手术日期与出院日期，计算并记录患者的术后住院天数，对比两组患者的该指标。

Measure time point of outcome：

At the time of patient discharge

Measure method：

The patient's operation date and discharge date were extracted from the hospital information system, the postoperative hospital length of stay was calculated and recorded, and the indicator was compared between the two groups.

指标中文名：

术后焦虑抑郁量表（HAD）

指标类型：

次要指标

Outcome：

Postoperative Hospital Anxiety and Depression Scale (HAD) Score

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

采用医院焦虑抑郁量表（HAD），由经过培训的研究人员于各测量时间点向患者发放量表，指导患者独立完成填写，分别统计焦虑分量表（HAD-A）、抑郁分量表（HAD-D）得分及总分，记录并对比两组患者的评分结果。

Measure time point of outcome：

24h postoperatively

Measure method：

The Hospital Anxiety and Depression Scale (HAD) was used. Trained researchers distributed the scale to patients at each measurement time point, and guided patients to complete it independently. The scores of the anxiety subscale (HAD-A), depression subscale (HAD-D) and total score were calculated, and the results of the two groups were recorded and compared.

指标中文名：

测术后 恢复质量量表（QoR-15）

指标类型：

次要指标

Outcome：

Postoperative Quality of Recovery-15 (QoR-15) Score

Type：

Secondary indicator

测量时间点：

术后24小时

测量方法：

采用15项恢复质量量表（QoR-15），由经过培训的研究人员于各测量时间点向患者发放量表，指导患者独立完成填写，统计量表总分，记录并对比两组患者的评分结果。

Measure time point of outcome：

24h postoperatively

Measure method：

The 15-item Quality of Recovery Scale (QoR-15) was used. Trained researchers distributed the scale to patients at each measurement time point, guided patients to complete it independently, calculated the total score of the scale, and recorded and compared the scores of the two groups.

指标中文名：

PCIA总按压次数、有效按压次数

指标类型：

次要指标

Outcome：

Total PCIA Presses and Effective PCIA Presses

Type：

Secondary indicator

测量时间点：

术后48小时

测量方法：

术后48小时镇痛结束时，从PCIA电子泵系统中直接提取并记录患者的总按压次数、有效按压次数，统计两组患者的上述指标。

Measure time point of outcome：

48 hours postoperatively

Measure method：

At the end of 48-hour postoperative analgesia, the total number of presses and effective presses of each patient were directly extracted and recorded from the PCIA electronic pump system, and the above indicators were counted in both groups.

指标中文名：

布鲁格曼舒适量表（BCS）

指标类型：

主要指标

Outcome：

Bruggrmann Comfort Scale (BCS) Score

Type：

Primary indicator

测量时间点：

术后2小时、6小时、12小时、24小时、48小时

测量方法：

采用布鲁格曼舒适量表（BCS），由经过培训的研究人员，于各测量时间点对患者的舒适状态进行评估： 0分=持续疼痛；1分=安静时无痛，深呼吸或咳嗽时出现严重疼痛；2分=安静时无痛，深呼吸或咳嗽时出现轻微疼痛；3分=深呼吸时无痛；4分=咳嗽时也无痛。 根据患者实际状态判定对应评分并记录。

Measure time point of outcome：

2h, 6h, 12h, 24h, 48h postoperatively

Measure method：

The Bruggrmann Comfort Scale (BCS) was used to assess the patient's comfort status by trained researchers at each measurement time point: Score 0 = Persistent pain; Score 1 = No pain at rest, but severe pain during deep breathing or coughing; Score 2 = No pain at rest, but mild pain during deep breathing or coughing; Score 3 = No pain during deep breathing; Score 4 = No pain even during coughing. The corresponding score was determined and recorded according to the patient's actual status.

指标中文名：

静息状态下视觉模拟量表（VAS）评分

指标类型：

主要指标

Outcome：

Visual Analogue Scale (VAS) Pain Score at Rest

Type：

Primary indicator

测量时间点：

术后2小时、6小时、12小时、24小时、48小时

测量方法：

采用视觉模拟评分法（VAS），使用标准化VAS评分尺（0分端代表无痛，10分端代表可想象的最剧烈疼痛），由经过培训的研究人员，于各测量时间点向患者展示评分尺，让患者根据自身静息状态下的疼痛感受，自主选择对应评分数值并记录。

Measure time point of outcome：

2h, 6h, 12h, 24h, 48h postoperatively

Measure method：

The Visual Analogue Scale (VAS) was adopted. A standardized VAS scale (0 = no pain, 10 = the worst imaginable pain) was used. At each measurement time point, trained researchers presented the scale to patients, and patients independently selected the corresponding score according to their pain perception at rest, which was then recorded.

指标中文名：

第一次补救镇痛时间、 48 小时内补救镇痛次数

指标类型：

次要指标

Outcome：

Time to First Rescue Analgesia and Number of Rescue Analgesic Episodes within 48 Hours Postoperatively

Type：

Secondary indicator

测量时间点：

术后48小时内

测量方法：

术后48小时内，记录患者首次使用补救镇痛药物的时间点，同时统计该时间段内患者的补救镇痛总次数，记录并对比两组患者的上述指标。

Measure time point of outcome：

Within 48 hours postoperatively

Measure method：

Within 48 hours postoperatively, the time point of the patient's first use of rescue analgesics was recorded, and the total number of rescue analgesic episodes in this period was counted. The above indicators in both groups were recorded and compared.

指标中文名：

不良反应发生率（恶心呕吐、头晕嗜睡、皮肤瘙痒、幻觉瞻望、呼吸抑制 SpO?<90%等）

指标类型：

次要指标

Outcome：

Incidence of Adverse Reactions (Nausea and Vomiting, Dizziness and Drowsiness, Pruritus, Hallucinations and Delirium, Respiratory Depression with SpO?<90%)

Type：

Secondary indicator

测量时间点：

术后48小时内

测量方法：

术后48小时内，由经过培训的研究人员观察并记录患者出现的恶心呕吐、头晕嗜睡、皮肤瘙痒、幻觉瞻望、呼吸抑制（SpO?<90%）等不良反应事件，统计两组患者的各类不良反应发生率并进行对比。

Measure time point of outcome：

Within 48 hours postoperatively

Measure method：

Within 48 hours postoperatively, trained researchers observed and recorded adverse events including nausea and vomiting, dizziness and drowsiness, pruritus, hallucinations and delirium, and respiratory depression (SpO?<90%) in patients. The incidence of each type of adverse reaction in both groups was calculated and compared.

指标中文名：

Ramsay镇静评分

指标类型：

主要指标

Outcome：

Ramsay Sedation Scale Score

Type：

Primary indicator

测量时间点：

术后2小时、6小时、12小时、24小时、48小时

测量方法：

采用Ramsay镇静评分量表，由经过培训的研究人员，于各测量时间点对患者的镇静状态进行评估： 1分=烦躁不安；2分=安静合作、定向力正常；3分=嗜睡、对指令反应敏捷；4分=睡眠状态、可迅速唤醒；5分=睡眠状态、对呼叫反应迟钝；6分=深睡状态、呼唤无反应。 根据患者实际状态判定对应评分并记录。

Measure time point of outcome：

2h, 6h, 12h, 24h, 48h postoperatively

Measure method：

The Ramsay Sedation Scale was used to assess the patient's sedation status by trained researchers at each measurement time point: Score 1 = Anxious and agitated; Score 2 = Cooperative, oriented and calm; Score 3 = Drowsy with quick response to commands; Score 4 = Asleep, easily aroused; Score 5 = Asleep, sluggish response to verbal calls; Score 6 = Deep sleep, no response to stimulation. The corresponding score was determined and recorded according to the patient's actual status.

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 75 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）：

由不参与受试者筛选、干预实施及 结局评价的第三方统计人员，采用SPSS 26.0软件生成随机数字序列，按 1:1 的比例将受试者分为试验组（氢吗啡酮PCIA组：60例）与对照组（舒 芬太尼PCIA组：60例）

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

Randomization will be performed by an independent statistician who is not involved in subject screening, intervention administration or outcome assessment. A random number sequence will be generated using SPSS 26.0 software, and subjects will be assigned to the experimental group (hydromorphone PCIA group, 60 cases) and the control group (sufentanil PCIA group, 60 cases) at a 1:1 ratio.

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：

对研究参与者、研究者设盲

Blinding：

Blinding research participants and researchers

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）：

本研究不进行原始数据共享

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

This study does not share individual participant 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：

1. 数据采集与记录：所有受试者的基线资料、手术信息、术后镇痛评分、生命体征及不良反应，均由经过培训的研究者按方案规定时间点，如实记录，如需修改，需在修改处签名并注明日期。 2. 数据审核与质控：由专人对纸质记录和手动录入的Excel电子数据进行100%核对，发现疑问及时反馈研究者核实更正，确保数据真实、完整、一致。 3. 数据保存与隐私保护：电子数据采用加密文件存储并定期备份；纸质记录表由项目负责人统一归档保存，保存期限不少于研究结束后5年。在所有数据收集后均进行匿名化处理，所有数据仅授权研究团队人员访问，严 格保护受试者隐私。

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

1. Data Collection and Recording: All subjects' baseline information, surgical details, postoperative analgesia scores, vital signs, and adverse reactions will be truthfully recorded by trained investigators strictly in accordance with the time points specified in the study protocol. Any modification to the recorded content must be signed and dated by the modifier to ensure traceability of all records.2. Data Review and Quality Control: A dedicated quality control officer will conduct 100% verification of both paper-based original records and manually entered Excel electronic data. Any identified discrepancies will be promptly fed back to the investigators for verification and correction to ensure the authenticity, completeness, and consistency of the data.3. Data Storage and Privacy Protection: Electronic data will be stored in encrypted files with regular backups; paper-based record forms will be archived and stored uniformly by the project principal investigator for a period of no less than 5 years after the completion of the study. All data will be anonymized after collection, and access to the data is restricted exclusively to authorized members of the research team to strictly protect the privacy of the subjects.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-01 18:12:23