ChiCTR2600125201 版本V1.1 版本创建时间2026/05/22 17:50:31 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：

 ChiCTR2600125201 

最近更新日期：

Date of Last Refreshed on：

 2026-05-22 10:19:15 

注册时间：

Date of Registration：

 2026-05-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

布比卡因脂质体胸横肌平面阻滞对开胸心脏术后疼痛及快速康复的影响

Public title：

Effect of Liposomal Bupivacaine for Transversus Thoracis Plane Block on Postoperative Pain and Enhanced Recovery After Cardiac Thoracotomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

布比卡因脂质体胸横肌平面阻滞对开胸心脏术后疼痛及快速康复的影响

Scientific title：

Effect of Liposomal Bupivacaine for Transversus Thoracis Plane Block on Postoperative Pain and Enhanced Recovery After Cardiac Thoracotomy

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：

周晓辉 

研究负责人：

王莉 

Applicant：

Xiaohui Zhou 

Study leader：

Li Wang 

申请注册联系人电话：

Applicant telephone：

 +86 181 3260 5201

研究负责人电话：

Study leader's
telephone：

+86 159 3115 0195

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：

 450504930@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 515145392@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：

河北省石家庄市裕华区东岗路89号

研究负责人通讯地址：

河北省石家庄市裕华区东岗路89号

Applicant address：

No. 89 Donggang Road, Yuhua District, Shijiazhuang City, Hebei Province, China

Study leader's address：

No. 89 Donggang Road, Yuhua District, Shijiazhuang City, Hebei Province, 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：

河北医科大学第一医院

Applicant's institution：

The First Hospital of Hebei Medical University

研究负责人所在单位：

河北医科大学第一医院

Affiliation of the Leader：

The First Hospital of Hebei 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]研审第(Y046)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：

河北医科大学第一医院临床研究伦理审查委员会

Name of the ethic committee：

Clinical Research Ethics Committee of The First Hospital of Hebei Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-13 00:00:00

伦理委员会联系人：

赵玉琦

Contact Name of the ethic committee：

Zhao Yuqi

伦理委员会联系地址：

河北省石家庄市裕华区东岗路89号

Contact Address of the ethic committee：

No. 89 Donggang Road, Yuhua District, Shijiazhuang City, Hebei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 311 8715 6679

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：

河北医科大学第一医院

Primary sponsor：

The First Hospital of Hebei Medical University

研究实施负责（组长）单位地址：

河北省石家庄市裕华区东岗路89号

Primary sponsor's address：

No. 89 Donggang Road, Yuhua District, Shijiazhuang City, Hebei Province, 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)：

河北省

市(区县)：

石家庄市

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

河北医科大学第一医院

具体地址：

河北省石家庄市裕华区东岗路89号

Institution
hospital：

The First Hospital of Hebei Medical University

Address：

No. 89 Donggang Road, Yuhua District, Shijiazhuang City, Hebei Province, China

经费或物资来源：

自筹

Source(s) of funding：

Raise independently

研究疾病：

开胸心脏术后疼痛及快速康复  

Target disease：

Postoperative Pain and Enhanced Recovery After Cardiac Thoracotomy

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：

本研究在临床与层面探究布比卡因脂质体用于超声引导下胸横肌平面阻滞能否有效减轻开胸心脏手术围术期应激及术后疼痛的发生；并进一步明确是否通过减轻炎症反应抑制中枢敏化发挥作用.  

Objectives of Study：

The purpose of this study was to clinically explore whether the application of liposomal bupivacaine in ultrasound-guided transversus thoracis plane block can effectively reduce perioperative stress and the incidence of postoperative pain in patients undergoing cardiac thoracotomy. Additionally, this study further aimed to clarify whether these beneficial effects are exerted by alleviating the inflammatory response and thereby inhibiting central sensitization.

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.择期拟行正中开胸心脏手术患者； 2.性别不限； 3.年龄大于18岁； 4.美国麻醉医师协会（ASA）分级Ⅲ-Ⅳ级，NYHA心功能分级Ⅱ-Ⅲ级； 5.签署知情同意书。

Inclusion criteria

1. Patients scheduled for elective median sternotomy cardiac surgery; 2. No gender restriction; 3. Age > 18 years old; 4. American Society of Anesthesiologists (ASA) physical status classification Ⅲ-Ⅳ, and New York Heart Association (NYHA) functional classification Ⅱ-Ⅲ; 5. Signed informed consent form.

排除标准：

1.穿刺部位感染； 2.胸部畸形； 3.凝血功能异常； 4.术前左室功能严重低下、射血分数<30%；术前血流动力学不稳定，需要主动脉内球囊反搏支持； 5.安装心脏起搏器；急诊或二次开胸； 6.搭桥手术同期需要在体外循环下行其它心脏手术，如瓣膜置换或成形、室壁瘤切除等；合并肿瘤、感染性、精神性疾病； 7.有慢性疼痛史； 8.有局部麻醉药过敏史； 9.长期服用阿片类或其它成瘾性药物的患者； 10.无法提供知情同意； 11.无法完成疼痛评分量表； 12.无法理解或操作患者自控镇痛（PCA）机； 13.以及 在过去 30 天内参与了另一项评估实验性药物的研究。

Exclusion criteria：

1. Infection at the puncture site;? 2. Thoracic deformity;? 3. Abnormal coagulation function;? 4. Severely impaired left ventricular function before surgery with an ejection fraction < 30%; unstable hemodynamics before surgery requiring intra-aortic balloon pump support;? 5. Having a cardiac pacemaker implanted; emergency surgery or re-thoracotomy;? 6. Other cardiac surgeries requiring cardiopulmonary bypass during coronary artery bypass grafting, such as valve replacement or plasty, ventricular aneurysm resection, etc.; complicated with tumors, infectious diseases, or mental diseases;? 7. History of chronic pain;? 8. History of allergy to local anesthetics;? 9. Patients taking opioids or other addictive drugs for a long time;? 10. Inability to provide informed consent;? 11. Inability to complete the pain rating scale;? 12. Inability to understand or operate the patient-controlled analgesia (PCA) pump;? 13. Participated in another study to evaluate experimental drugs in the past 30 days.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

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

干预措施：

Interventions：

组别：

全身麻醉+生理盐水+术后静脉自控镇痛泵组（S 组）

样本量：

 50

Group：

Group S: General Anesthesia + Normal Saline + Postoperative Intravenous PCA Pump

Sample size：

干预措施：

S 组：常规全身麻醉，术后常规静脉镇痛，手术结束后静脉连接电子镇痛泵进行自控镇痛，镇痛药液配方：舒芬太尼 2.5μg/kg+地佐辛0.5mg/kg+生理盐水至 100ml，速度为 2ml/h，无负荷剂量。

干预措施代码：

Intervention：

Patients in this group received routine general anesthesia and routine postoperative intravenous analgesia. At the end of the surgery, an electronic analgesia pump was intravenously connected for patient-controlled analgesia. The formula of the analgesic solution was as follows: sufentanil 2.5μg/kg + dezocine 0.5mg/kg + normal saline to 100ml, with an infusion rate of 2ml/h and no loading dose.

Intervention code：

组别：

全身麻醉+罗哌卡因胸横肌平面阻滞+术后静脉自控镇痛泵组（LP 组）

样本量：

 50

Group：

Group LP: General Anesthesia + Ropivacaine Transversus Thoracis Plane Block + Postoperative Intravenous PCA Pump

Sample size：

干预措施：

LP 组：麻醉诱导前在超声引导下行胸骨旁肋间平面阻滞，两侧分别给予 0.25%罗哌卡因 20ml，引流管周围皮下阻滞浸润10ml。

干预措施代码：

Intervention：

Patients in this group received ultrasound-guided parasternal intercostal plane block before anesthesia induction. Specifically, 20ml of 0.25% ropivacaine was administered on each side, and 10ml of the same drug was injected subcutaneously around the drainage tube for block infiltration. Postoperative analgesia was maintained with an intravenous patient-controlled analgesia pump, and the formula of the analgesic solution was consistent with that of Group S.

Intervention code：

组别：

全身麻醉+布比卡因脂质体胸横肌平面阻滞+术后静脉自控镇痛泵组（LB 组）

样本量：

 50

Group：

Group LB: General Anesthesia + Liposomal Bupivacaine Transversus Thoracis Plane Block + Postoperative Intravenous PCA Pump

Sample size：

干预措施：

LB 组：麻醉诱导前在超声引导下行胸骨旁肋间平面阻滞，两侧分别给予 0.53%布比卡因脂质体 20ml，引流管周围皮下阻滞浸润 10ml（布比卡因脂质体 266mg，20ml 加生理盐水稀释至 50ml）

干预措施代码：

Intervention：

Patients in this group received general anesthesia combined with liposomal bupivacaine for transversus thoracis plane block. Specifically, before anesthesia induction, parasternal intercostal plane block was performed under ultrasound guidance. 20ml of 0.53% liposomal bupivacaine was administered on each side (bilateral administration). Additionally, 10ml of liposomal bupivacaine was injected subcutaneously around the drainage tube for block infiltration, with the following preparation: 266mg liposomal bupivacaine (20ml) diluted with normal saline to a total volume of 50ml. Postoperative analgesia was maintained with an intravenous patient-controlled analgesia pump, and the formula of the analgesic solution was consistent with that of Group S.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

 石家庄市 

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

 河北医科大学第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Hospital of Hebei Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

开胸心脏手术患者术后48h静息和活动状态下的疼痛视觉模拟评分（VAS 评分）（若患者处于插管/镇静状态，采用成人非言语疼痛量表 NVPS-R 评估）

指标类型：

主要指标

Outcome：

Visual Analog Scale (VAS) scores were used to evaluate the pain of patients undergoing cardiac thoracotomy at rest and during activity within 48 hours after surgery. If the patients were in intubation or sedation status, the Revised Non-Verbal Pain Scale (NVPS-R) for adults was adopted for pain assessment.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血流动力学指标：切皮前后、锯胸骨前后、闭合胸骨前后的血压、心率变化

指标类型：

次要指标

Outcome：

Hemodynamic Indicators:The changes of blood pressure and heart rate were monitored and recorded at the following time points: before and after skin incision, before and after sternotomy, and before and after sternal closure. These hemodynamic indicators were continuously tracked throughout the surgical process to evaluate the impact of anesthesia and block intervention on the patient's circulatory function.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血气及代谢指标：入室镇静后、术中、术后 6h/12h/24h 动脉血乳酸和血糖值

指标类型：

次要指标

Outcome：

Blood Gas and Metabolic Indicators: Arterial blood lactic acid and blood glucose levels were measured and recorded at the following time points: after induction of sedation on admission, during surgery, and at 6h, 12h, and 24h postoperatively. These indicators were used to evaluate the patient's metabolic status and stress response during the perioperative period, providing objective data support for the effectiveness of analgesic intervention.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

应激与炎症指标：血清中 IL-1β、C - 反应蛋白、HMGB-1（炎症），皮质醇、肾上腺素、去甲肾上腺素（应激）浓度

指标类型：

次要指标

Outcome：

Stress and inflammatory indicators: Concentrations of serum interleukin-1β (IL-1β), C-reactive protein (CRP), high-mobility group box 1 protein (HMGB-1) (inflammatory markers), cortisol, epinephrine, and norepinephrine (stress markers)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药物使用指标：术中及术后 48h 阿片类药物、血管活性药物使用量；

指标类型：

次要指标

Outcome：

Medication use indicators: Consumption of opioids and vasoactive drugs during surgery and within 48 hours postoperatively.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后康复指标：气管导管拔除时间、引流管留置时间、排气排便时间、下床活动时间、ICU 停留时间、总住院时间

指标类型：

次要指标

Outcome：

Postoperative recovery indicators: Time to tracheal extubation, duration of drainage tube indwelling, time to first flatus and defecation, time to ambulation, length of ICU stay, and total length of hospital stay.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应指标：术后谵妄、恶心呕吐、寒战、心律失常、呼吸抑制、术区感染、肺部并发症等围术期不良事件发生情况

指标类型：

次要指标

Outcome：

Adverse reaction indicators: The incidence of perioperative adverse events, including postoperative delirium, nausea and vomiting, shivering, arrhythmia, respiratory depression, surgical site infection, pulmonary complications, etc.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

远期恢复质量指标：术后 3 个月患者的恢复质量 Q15 量表评分

指标类型：

次要指标

Outcome：

Long-term recovery quality indicators: Quality of Recovery Score Q15 (QoR?15) at 3 months postoperatively.

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：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 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）：

由河北医科大学第一医院该项目非临床研究人员利用 SPSS 26.0 统计软件产生随机数字表，根据受试者入组顺序，按 1:1:1 的比例随机分配至 S 组、LP 组或 LB 组。随机序列及分配方案由专人密封保管，执行人员盲法领取。

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

Non-clinical researchers assigned to this project at the First Hospital of Hebei Medical University generated a random number table using SPSS 26.0 software. Participants were randomly assigned to Group S, Group LP, or Group LB at a 1:1:1 ratio according to their enrollment order. The random sequence and allocation plan were kept in sealed envelopes by dedicated personnel, and investigators obtained assignments in a blinded fashion

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：

盲法维持：术后评估者（疼痛评分、不良反应记录）与给药医师、手术医师严格分离；

Blinding：

Blinding was maintained by strict separation of postoperative assessors (responsible for pain scores and adverse reaction recording) from the administering physician and surgeons.

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）：

试验完成后6个月内，网络平台名称：临床试验原始数据（IPD）共享平台:ResMan, 网址：www.medresman.org.cn

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

Time to open to the public: within 6 months after the trial is completed. ResMan research manager, website: www.medresman.org.cn

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：

原始记录采用Excel数据库，病历记录表采用office word软件保存和管理，纸质文件由研究负责人保存。

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

The original data are summerized by excel software. The case record form are reposited and managed by office word software, whose version materials is preserved by study applicant.

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：

  2026-05-22 10:15:51