ChiCTR2600125668 版本V1.0 版本创建时间2026/05/29 10:37:17 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：

 ChiCTR2600125668 

最近更新日期：

Date of Last Refreshed on：

 2026-05-29 10:37:06 

注册时间：

Date of Registration：

 2026-05-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经引流管注入布比卡因脂质体减轻乳腺癌根治术后疼痛的临床研究

Public title：

Clinical Study of Liposomal Bupivacaine via Drainage Tube for Postoperative Pain Relief after Radical Mastectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经引流管注入布比卡因脂质体减轻乳腺癌根治术后疼痛的临床研究

Scientific title：

Clinical Study of Liposomal Bupivacaine via Drainage Tube for Postoperative Pain Relief after Radical Mastectomy

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：

欧阳榕一 

研究负责人：

刘玉林 

Applicant：

Rongyi Ouyang 

Study leader：

Liu Yulin 

申请注册联系人电话：

Applicant telephone：

 +86 15283896821

研究负责人电话：

Study leader's
telephone：

+86 830 3165273

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：

 1694142361@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 2393284485@qq.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：

中国四川省泸州市江阳区太平街25号

研究负责人通讯地址：

中国四川省泸州市江阳区太平街25号

Applicant address：

25 Taiping Street, Jiangyang District, Luzhou, Sichuan, China

Study leader's address：

25 Taiping Street, Jiangyang District, Luzhou, Sichuan, 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：

西南医科大学附属医院

Applicant's institution：

Affiliated Hospital of Southwest Medical University

研究负责人所在单位：

西南医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Southwest 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：

 KY2026334

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：

西南医科大学附属医院临床试验伦理委员会

Name of the ethic committee：

The Clinical Research Ethics Committee Affiliated Hospital of Southwest Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-23 00:00:00

伦理委员会联系人：

张增瑞

Contact Name of the ethic committee：

Zhang Zengrui

伦理委员会联系地址：

中国四川省泸州市江阳区太平街25号

Contact Address of the ethic committee：

25 Taiping Street, Jiangyang District, Luzhou, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 830 3165273

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 274692738@qq.com

研究实施负责（组长）单位：

西南医科大学附属医院

Primary sponsor：

Affiliated Hospital of Southwest Medical University

研究实施负责（组长）单位地址：

中国四川省泸州市江阳区太平街25号

Primary sponsor's address：

25 Taiping Street, Jiangyang District, Luzhou, Sichuan, 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)：

四川

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

西南医科大学附属医院

具体地址：

中国四川省泸州市江阳区太平街25号

Institution
hospital：

Affiliated Hospital of Southwest Medical University

Address：

25 Taiping Street, Jiangyang District, Luzhou, Sichuan, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

研究疾病：

乳腺癌;术后急性疼痛  

Target disease：

breast cancer；Postoperative acute pain

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：

主要目的： 评估长效布比卡因脂质体经切口引流管单次给药用于乳腺癌根治术后镇痛的有效性，特别是延长镇痛持续时间、减少术后阿片类药物（吗啡）使用量方面的效果。 次要目的： 评估该镇痛方案的安全性（局麻药毒性反应、伤口愈合、引流管相关并发症等），及其对患者术后早期康复质量（首次下床活动时间、住院天数）的影响。  

Objectives of Study：

Main objective:To evaluate the efficacy of a single administration of long-acting bupivacaine liposomes through a surgical drainage tube for postoperative analgesia after breast cancer radical surgery, particularly in terms of prolonging the duration of analgesia and reducing the use of postoperative opioid drugs (morphine).Secondary objective:To assess the safety of this analgesic regimen (local anesthetic toxicity reactions, wound healing, drainage tube-related complications, etc.) and its impact on the quality of early postoperative rehabilitation (time to first ambulation, length of hospital stay) of patients.

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18-64岁，女性； 2.择期行单侧乳腺癌根治术（含改良根治术）； 3.ASA分级1-III级； 4.体重 ≥ 50 kg； 5.体质指数（BMI）＜ 30 kg/^2； 6.术前能够理解视觉模拟评分（VAS）使用方法，无语言、听力或认知障碍，能配合术后疼痛评估； 7.术后可成功留置切口引流管（用于给药及引流）； 8.同意使用患者自控静脉镇痛泵（PCIA）作为统一的补救镇痛措施； 9.自愿签署知情同意书；

Inclusion criteria

1.Age: 18-64 years old, female; 2.Elective unilateral radical mastectomy for breast cancer (including modified radical mastectomy); 3.ASA classification I-III; 4.Weight >= 50 kg; 5.Body mass index (BMI) < 30 kg/m^2; 6.Before the operation, the patient was able to understand the usage of the Visual Analogue Scale (VAS), had no language, hearing or cognitive impairments, and could cooperate with the postoperative pain assessment; 7.Postoperative incision drainage tubes can be successfully placed (for drug administration and drainage). 8.Agree to use patient-controlled intravenous analgesia pumps (PCIA) as a unified remedial analgesia measure; 9.Voluntarily sign the informed consent form;

排除标准：

1.对酰胺类局麻药或脂质体成分过敏者； 2.术前长期使用阿片类药物（≥3个月）或有药物滥用史； 3.合并严重心律失常、未控制的高血压、严重肝肾功能不全； 4.术前已有慢性疼痛综合征或神经精神疾病影响疼痛评估； 5.手术范围需扩大至胸壁大范围切除或皮瓣重建者； 6.妊娠或哺乳期女性； 7.同时参与其他干预性临床研究； 8.术前存在手术侧胸壁或引流管拟留置区域的皮肤感染、破损、蜂窝织炎或植入物感染风险； 9.在引流管放置禁忌（如广泛胸壁放射性皮炎、严重凝血功能障碍、拟穿刺部位解剖异常等）； 10.凝血功能障碍（血小板＜80×10^9/L，或INR＞1.5，或PTT延长＞正常上限1.5倍），或正在接受不能中断的抗凝/抗血小板治疗（如华法林、利伐沙班、氯吡格雷等，阿司匹林≤100mg/天除外）； 11.合并严重全身感染、脓毒症或术前体温＞38.5℃； 12.研究者判断存在任何可能增加局麻药毒性反应风险的情况（如严重低蛋白血症、未纠正的酸中毒、严重电解质紊乱）； 13.任何原因导致无法放置或无法保留引流管（如既往同侧胸壁手术致严重粘连、胸廓畸形等）； 14.有恶性高热个人史或家族史； 15.研究者认为不适宜参加本研究的其他情况（如依从性差、无法完成随访等）；

Exclusion criteria：

1.Those who are allergic to amide local anesthetics or liposome components; 2.Long-term preoperative use of opioid drugs (>=3 months) or a history of drug abuse; 3.Combined with severe arrhythmia, uncontrolled hypertension, and severe liver and kidney dysfunction; 4.There were already chronic pain syndromes or neuropsychiatric disorders affecting the pain assessment before the operation; 5.For cases where the surgical scope needs to be expanded to extensive chest wall resection or flap reconstruction; 6.Pregnant or lactating women; 7.At the same time, participate in other interventional clinical studies; 8.There is a risk of skin infection, damage, cellulitis or implant infection in the chest wall on the surgical side or the area where the drainage tube is intended to be indwelled before the operation; 9.Contraindications for the placement of drainage tubes (such as extensive radiation dermatitis of the chest wall, severe coagulation dysfunction, anatomical abnormalities at the intended puncture site, etc.); 10.Coagulation dysfunction (platelet count < 80×10^9/L, or INR > 1.5, or PTT prolonged > 1.5 times the upper limit of normal), or currently receiving uninterrupted anticoagulant/antiplatelet therapy (such as warfarin, rivaroxaban, clopidogrel, etc., except for aspirin ≤100mg/ day); 11.Combined with severe systemic infection, sepsis or preoperative body temperature > 38.5℃; 12.The researchers judged that there were any conditions that might increase the risk of toxic reactions to local anesthetics (such as severe hypoproteinemia, uncorrected acidosis, and severe electrolyte imbalance). 13.Any reason that prevents the placement or retention of the drainage tube (such as severe adhesions caused by previous ipsilateral chest wall surgery, thoracic deformity, etc.); 14.There is a personal or family history of malignant high fever; 15.Other circumstances that the researcher deems unsuitable for participation in this study (such as poor compliance, inability to complete follow-up, etc.);

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2027-03-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-02-20 00:00:00

干预措施：

Interventions：

组别：

空白对照组

样本量：

 33

Group：

Blank control group

Sample size：

干预措施：

0.9%生理盐水 20 ml 经切口引流管单次注射

干预措施代码：

Intervention：

A single injection of 20 ml of 0.9% normal saline through an incision drainage tube

Intervention code：

组别：

阳性对照组

样本量：

 33

Group：

Positive control group

Sample size：

干预措施：

0.5%罗哌卡因 20 ml 经切口引流管单次注射

干预措施代码：

Intervention：

A single injection of 20 ml of 0.5% ropivacaine through an incision drainage tube

Intervention code：

组别：

试验组

样本量：

 34

Group：

Experimental group

Sample size：

干预措施：

经引流管单次推注布比卡因脂质体（剂量133mg，加生理盐水至总体积20ml）

干预措施代码：

Intervention：

A single injection of bupivacaine liposome (133mg, added with normal saline to a total volume of 20ml) was administered through a drainage tube.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 西南医科大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Hospital of Southwest Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后0～72小时内吗啡累积消耗量（mg）

指标类型：

主要指标

Outcome：

Cumulative consumption of morphine (mg) within 0 to 72 hours after the operation

Type：

Primary indicator

测量时间点：

于术后2小时、4小时、8小时、12小时、24小时、36小时、48小时、72小时共8个时间点，分别记录PCIA泵累积按压次数，并按单次按压剂量1mg计算至各时间点的吗啡累积消耗量（mg）

测量方法：

所有患者术后统一连接吗啡患者自控静脉镇痛泵（PCIA），设置为：背景剂量0.5 mg/h，单次按压剂量1 mg，锁定时间10分钟。术后2小时、4小时、8小时、12小时、24小时、36小时、48小时、72小时共8个时间点，由经过培训且不知分组的研究人员分别记录PCIA泵的累积按压次数，按单次按压剂量1 mg计算至各时间点的吗啡累积消耗量（mg），公式为：吗啡累积消耗量（mg）= 累积按压次数 × 1

Measure time point of outcome：

At 8 time points including 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72

Measure method：

All patients were uniformly connected to the patient-controlled intravenous analgesia pump (PCIA) of morphine after the operation, which was set as follows: background dose 0.5 mg/h, single compression dose 1 mg, and lock time 10 minutes. At a total of 8 time points including 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours after the operation, the cumulative number of compressions of the PCIA pump was recorded by trained researchers who were not grouped. The cumul

指标中文名：

静息时VAS评分

指标类型：

次要指标

Outcome：

VAS score at rest

Type：

Secondary indicator

测量时间点：

后2小时、4小时、8小时、12小时、24小时、36小时、48小时、72小时共8个时间点分别测量静息状态下的VAS评分。

测量方法：

采用标准视觉模拟评分法进行测量。

Measure time point of outcome：

The VAS scores at rest were measured at a total of 8 time points, namely 2 hours, 4 hours, 8 hours,

Measure method：

The measurement was conducted using the standard Visual Analogue Scale.

指标中文名：

不良事件（恶心、呕吐、瘙痒、局麻药毒性反应等）

指标类型：

次要指标

Outcome：

Adverse events (nausea, vomiting, pruritus, local anesthetic toxicity reactions, etc.

Type：

Secondary indicator

测量时间点：

术后0～72h连续观察，随时记录

测量方法：

采用主动询问与临床观察相结合的方法进行不良事件监测。

Measure time point of outcome：

Continuous observation was conducted from 0 to 72 hours after the operation, and records were made a

Measure method：

Adverse event monitoring was conducted by combining active inquiry with clinical observation.

指标中文名：

术后首次补救镇痛时间（小时）

指标类型：

主要指标

Outcome：

The time of the first postoperative remedial analgesia (hours)

Type：

Primary indicator

测量时间点：

从试验药物给药结束（引流管推注完毕）的时刻开始，连续监测至患者首次主动按压PCIA泵的时刻为止，记录两者之间的时间间隔

测量方法：

术后首次补救镇痛时间通过电子患者自控静脉镇痛泵（PCIA泵）内置的电子日志系统进行测量。以引流管内研究药物推注完毕的时刻作为时间起点（T0，由给药医师记录，精确至分钟），自该时刻起，PCIA泵自动记录患者每一次按压镇痛泵按钮的准确时间戳（精确至分钟）。患者术后首次主动按压PCIA泵的时刻定义为T1，两者之间的时间间隔即为首次补救镇痛时间，计算公式为：（T1－T0）÷ 60，单位为小时，保留一位小数

Measure time point of outcome：

Starting from the moment when the administration of the test drug is completed (the drainage tube in

Measure method：

The time of the first postoperative remedial analgesia was measured by the electronic log system built into the electronic patient-controlled intravenous analgesia pump (PCIA pump). Taking the moment when the drug injection in the drainage tube is completed as the time starting point (T0, recorded by the dosing physician, accurate to the minute), from this moment on, the PCIA pump automatically records the exact timestamp (accurate to the minute) of each time the patient presses the analgesic pu

指标中文名：

伤口愈合情况

指标类型：

次要指标

Outcome：

The healing condition of the wound

Type：

Secondary indicator

测量时间点：

术后每日评估直至出院

测量方法：

采用临床视诊与触诊相结合的方法进行评估。

Measure time point of outcome：

Daily assessment after surgery until discharge.

Measure method：

The assessment was conducted by combining clinical visual examination with palpation.

指标中文名：

住院天数

指标类型：

次要指标

Outcome：

length of stay

Type：

Secondary indicator

测量时间点：

出院时记录

测量方法：

从医院病历首页及医院信息系统（HIS） 中直接摘录患者的手术日期和出院日期，按日历天数计算住院天数。

Measure time point of outcome：

Discharge Record

Measure method：

The surgery date and discharge date of the patient are directly extracted from the hospital's index page and the hospital information system (HIS), and the length of hospital stay is calculated based on the number of calendar days.

指标中文名：

活动时VAS评分

指标类型：

次要指标

Outcome：

VAS score during the activity

Type：

Secondary indicator

测量时间点：

术后2h、4h、8h、12h、24h、36h、48h、72h

测量方法：

采用标准视觉模拟评分法测量患者在标准化活动状态下的疼痛程度。

Measure time point of outcome：

2h、4h、8h、12h、24h、36h、48h、72h

Measure method：

The standard Visual Analogue Scale was used to measure the degree of pain of patients under standardized activity conditions.

指标中文名：

引流管相关并发症

指标类型：

次要指标

Outcome：

Complications related to the drainage tube

Type：

Secondary indicator

测量时间点：

术后每日评估直至拔管

测量方法：

采用每日临床观察与引流管护理记录相结合的方法进行评估。

Measure time point of outcome：

Postoperative daily assessment until extubation

Measure method：

The assessment was conducted by combining daily clinical observations with the nursing records of the drainage tubes.

指标中文名：

首次下床活动时间

指标类型：

次要指标

Outcome：

The first time to get out of bed for activities

Type：

Secondary indicator

测量时间点：

记录具体时间（小时）

测量方法：

采用临床观察与护理记录相结合的方法进行测量。

Measure time point of outcome：

Record the specific time (in hours)

Measure method：

The measurement was conducted by combining clinical observation with nursing records.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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 64 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由不参与临床分组、治疗及评估的独立统计人员（或主要研究者授权的第三方人员）采用随机数字表法或计算机统计软件（如SPSS、SAS或R软件）生成随机数列。

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

Random sequences are generated by independent statisticians who do not participate in clinical grouping, treatment and evaluation (or third-party personnel authorized by the principal investigator) using the random number table method or computer statistical software (such as SPSS, SAS or R software).

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：

双盲

Blinding：

Double blind

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）：

无

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

None

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：

本试验的数据采集与管理工作将严格遵循标准化、规范化及保密性原则。所有研究数据（包括人口学资料、病史、ASA分级、生命体征、VAS评分、PCIA泵记录、不良事件、伤口愈合及引流管情况、下床活动时间、住院天数等）均由经过统一培训且不知分组的研究护士或医师，依据原始病历、护理记录及专用评估量表直接摘录或记录至纸质版病例报告表，确保数据来源可溯。术后随访期内，PCIA泵记录的吗啡消耗量及首次按压时间通过电子日志导出并与护理记录双重复核；VAS评分由患者独立标记后即时记录；不良事件及伤口愈合情况每日评估后实时录入。所有纸质CRF表在完成后交由数据管理员进行双人独立录入与逻辑核查，录入至电子数据库（如EpiData或SPSS），发现异常或缺失数据时通过查询原始记录予以澄清。数据库设置访问密码及操作日志，仅限主要研究者和授权数据管理员登录。研究完成后，纸质资料存档于医院研究档案室，电子数据备份于医院内网专用服务器，保存期限为研究结束后10年，期间仅允许伦理委员会、申办者及监管部门依规查阅。

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

The data collection and management for this trial will strictly adhere to the principles of standardization, normalization and confidentiality. All research data (including demographic information, medical history, ASA classification, vital signs, VAS scores, PCIA pump records, adverse events, wound healing and drainage tube conditions, time of getting out of bed, length of hospital stay, etc.) are directly extracted or recorded by trained research nurses or physicians who are unaware of the groups, based on the original medical records, nursing records and specific assessment scales, onto paper-based case report forms, ensuring the traceability of the data sources. During the postoperative follow-up period, the morphine consumption and the first press time recorded by the PCIA pump are exported through electronic logs and double-checked with the nursing records; the VAS scores are marked independently by the patients and recorded immediately; adverse events and wound healing conditions are evaluated daily and entered in real time. All paper CRF forms are submitted to the data administrator for double-entry by two independent individuals and logical verification after completion. They are then entered into the electronic database (such as EpiData or SPSS). When abnormal or missing data are found, they are clarified by querying the original records. The database is set with access passwords and operation logs, and only the principal investigator and authorized data administrators are allowed to log in. After the completion of the study, the paper materials are archived in the hospital's research archive room, and the electronic data are backed up on a dedicated server within the hospital's intranet, with a retention period of 10 years after the study ends. During this period, only the ethics committee, the sponsor and the regulatory authorities are allowed to consult according to regulations.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-29 10:37:06