ChiCTR2600116783 版本V1.0 版本创建时间2026/01/14 18:01:47 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：

 ChiCTR2600116783 

最近更新日期：

Date of Last Refreshed on：

 2026-01-14 18:01:42 

注册时间：

Date of Registration：

 2026-01-14 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

布比卡因脂质体在超声引导下外周神经阻滞浸润浓度的探讨：一项序贯分配剂量研究

Public title：

Infiltration concentration of bupivacaine in liposome ultrasound-guided peripheral nerve block: a sequential dose-allocation study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

布比卡因脂质体在超声引导下外周神经阻滞浸润浓度的探讨：一项序贯分配剂量研究

Scientific title：

Infiltration concentration of bupivacaine in liposome ultrasound-guided peripheral nerve block: a sequential dose-allocation study

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：

林瑾 

研究负责人：

林瑾 

Applicant：

Jin Lin 

Study leader：

Jin Lin 

申请注册联系人电话：

Applicant telephone：

 +86 138 6016 4980

研究负责人电话：

Study leader's
telephone：

+86 138 6016 4980

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：

 116238174@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 116238174@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：

厦门市湖里区仙岳路3777号厦门弘爱医院

研究负责人通讯地址：

厦门市湖里区仙岳路3777号厦门弘爱医院

Applicant address：

No. 3777, Xianyue Road, Huli District, Xiamen City, Xiamen Humanity Hospital

Study leader's address：

No. 3777, Xianyue Road, Huli District, Xiamen City, Xiamen Humanity Hospital

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：

厦门弘爱医院

Applicant's institution：

Xiamen Humanity Hospital

研究负责人所在单位：

厦门弘爱医院

Affiliation of the Leader：

Xiamen Humanity Hospital

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：

 HAXM-MEC-20241212-075-01

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：

厦门弘爱医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Xiamen Humanity Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-12 00:00:00

伦理委员会联系人：

夏天

Contact Name of the ethic committee：

Tian Xia

伦理委员会联系地址：

厦门市湖里区仙岳路3777号厦门弘爱医院

Contact Address of the ethic committee：

No. 3777, Xianyue Road, Huli District, Xiamen City, Xiamen Humanity Hospital

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 592 526 1060

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：

厦门弘爱医院

Primary sponsor：

Xiamen Humanity Hospital

研究实施负责（组长）单位地址：

厦门市湖里区仙岳路3777号厦门弘爱医院

Primary sponsor's address：

No. 3777, Xianyue Road, Huli District, Xiamen City, Xiamen Humanity Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

厦门市

Country：

China

Province：

Fujian

City：

Xiamen

单位(医院)：

厦门弘爱医院

具体地址：

厦门市湖里区仙岳路3777号厦门弘爱医院

Institution
hospital：

Xiamen Humanity Hospital

Address：

No. 3777, Xianyue Road, Huli District, Xiamen City, Xiamen Humanity Hospital

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

研究疾病：

上肢骨折  

Target disease：

Upper limb fracture

研究疾病代码：

NC12.7

Target disease code：

NC12.7

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

布比卡因脂质体是一种新型的局部麻醉药，具有良好的渗透性和长效性，但在外周神经阻滞中应用布比卡因脂质体不同浓度的效果在临床上未有明确的指南推荐和可靠的证据，适宜的浸润浓度既能满足患者的术中镇痛需求，又可以减少患者术后疼痛，促进早期恢复，从而提高患者的满意度。 本研究旨在探讨探讨布比卡因脂质体应用于臂丛神经阻滞的不同浸润浓度对于患者术后恢复的影响，为围术期应用提供参考。  

Objectives of Study：

Bupivacaine liposome is a new type of local anesthetic with good permeability and long-acting properties, but there is no clear guideline recommendation and reliable evidence for the effect of different concentrations of bupivacaine liposome in peripheral nerve block. The appropriate infiltration concentration can not only meet the needs of patients for intraoperative analgesia, but also reduce postoperative pain and promote early recovery, thereby improving patient satisfaction. The purpose of this study was to investigate the effect of different infiltration concentrations of bupivacaine liposomes on postoperative recovery in patients with brachial plexus block, and to provide reference for perioperative application.

药物成份或治疗方案详述：

第1例患者给予肌间沟神经阻滞0.67%布比卡因脂质体 20ml,根据患者的反应，如患者术后48h疼痛>=3分以及肌力恢复不良，则下一例患者升高一个剂量梯度，否则保持原诱导剂量，三个相同且连续的浓度对患者术后疼痛有效以及肌力恢复无影响，则下一个患者减少到下一个更低的剂量水平。剂量梯度为0.1%。 

Description for medicine or protocol of treatment in detail：

The first patient was given 0.67% bupivacaine liposome 20ml of intermuscular sulcus nerve block. According to the patient's response, if the patient has pain >= 3 minutes 48h after surgery and poor muscle recovery, the next patient will increase the dose by one layer, otherwise the original induction dose will be maintained. Three identical and consecutive concentrations are effective for the patient's postoperative pain and have no effect on muscle recovery. The next patient will be reduced to the next lower dose level. The dose layer is 0.1%. 

纳入标准：

年龄在 18 岁至 65 岁之间；经影像学检查确诊为上肢骨折，包括但不限于肱骨骨折、尺桡骨骨折等；拟接受手术治疗的上肢骨折患者；骨折后至入组时间在规定范围内（例如 72 小时内）；美国麻醉医师协会（ASA）身体状况分级为 I - III 级，表明患者整体健康状况相对稳定，能够耐受麻醉和手术；术前评估神经功能正常，无神经损伤病史；患者自愿参加本研究，并签署知情同意书；预计术后住院观察时间能够满足研究随访要求。

Inclusion criteria

The upper limb fractures were diagnosed by imaging examination, including but not limited to humeral fractures, ulnar-radial fractures, etc.Patients with upper limb fractures who intend to undergo surgical treatment; the time from post-fracture to enrollment is within the specified range (e.g. within 72 hours);The American Society of Anesthesiologists (ASA) physical condition is graded I-III, indicating that the patient's overall health is relatively stable and can tolerate anesthesia and surgery;Preoperative evaluation of normal nerve function, no history of nerve injury;Patients voluntarily participated in this study and signed informed consent forms.It is expected that the postoperative hospitalization observation time can meet the follow-up requirements of the study.

排除标准：

对布比卡因或脂质体成分过敏者；存在严重的肝肾功能障碍，可能影响药物代谢和排泄；患有凝血功能障碍或正在接受抗凝治疗，增加出血风险；有神经系统疾病史，如神经退行性疾病、癫痫等，可能影响对疼痛感知和反应的评估；近期（如1个月内）使用过其他可能影响神经功能或疼痛感知的药物；患有精神疾病或认知障碍，无法配合研究或准确表述疼痛感受；处于妊娠期或哺乳期的女性患者；存在全身性感染或局部感染未得到有效控制。

Exclusion criteria：

Allergic to bupivacaine or liposomal components;There is severe liver and kidney dysfunction, which may affect drug metabolism and excretion;Suffering from coagulation dysfunction or receiving anticoagulation therapy, increasing the risk of bleeding.A history of neurological disorders, such as neurodegenerative disorders and epilepsy, may affect the assessment of pain perception and response.Have recently used other medications that may affect nerve function or pain perception, such as within one month.Suffering from mental illness or cognitive impairment, unable to cooperate with research or accurately describe pain feelings.Women who are pregnant or breastfeeding.There are systemic infections or local infections that have not been effectively controlled.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-02 00:00:00 至 To 2025-11-18 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 50

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

 厦门市 

Country：

China

Province：

Fujian

City：

Xiamen

单位(医院)：

 厦门弘爱医院 

单位级别：

 三级 

Institution
hospital：

Xiamen Humanity Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

NRS评分

指标类型：

主要指标

Outcome：

NRS score

Type：

Primary indicator

测量时间点：

术后48H

测量方法：

问询

Measure time point of outcome：

48H after surgery

Measure method：

Inquiry

指标中文名：

肌力评分

指标类型：

主要指标

Outcome：

Muscle strength score

Type：

Primary indicator

测量时间点：

术后48H

测量方法：

问询

Measure time point of outcome：

48H after surgery

Measure method：

Inquiry

指标中文名：

不良反应

指标类型：

次要指标

Outcome：

Adverse reaction

Type：

Secondary indicator

测量时间点：

术后48H

测量方法：

问询

Measure time point of outcome：

48H after surgery

Measure method：

Inquiry

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

无

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

None

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：

无

Blinding：

None

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）：

国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)。

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

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/).

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：

数据记录:录入CRF的数据必须与原始文件进行核对。任何研究相关文件必须存档，包括参与研究的受试者身份识别信息明细表。这份明细表和所签署的知情同意书是文档中的重要文件，由研究者保存。文件存档和保密原则:受试者(医院)相关文件按照中国相关法律存档。全部研究相关文件必须在研究结束后保存至少5年。全部受试者相关数据，包括身份识别信息和全部个人医学资料应视作保密文件， 按保密文件处理。数据核对程序应按最严格保密方式进行。在获得知情同意书之前，应向每位受试者说明个人资料、原始数据核对、稽查、电子数据处理和文件移交程序的机密性。研究工作组成员应对研究中的任何相关信息和结果保密，除非事先认可，严禁将这些向参加研究以外的任何人员泄露。 监察:由申办者及申办单位(厦门弘爱医院)临床研究负责人对本研究进行定期监查。监查程序包括研究开始前一次或多次现场监查，以及定期进行中期现场监查。现场监查期间，将检查 CRF 录入完成情况，研究方案的依从性和其他质量管理规范情况，将 CRF 录入数据与原始数据对比等。 数据录入与锁定:数据录入与管理采用 EpiDdata3.1 管理。为保证数据准确性，应由两位数据管理员独 立进行双份录入并校对、核查并进行修改，直至两份数据库完全一致。由数据管理员和统计人员及主要研究者共同完成数据的盲态审核，发现问题进行修改，确认无误后，由数据管理员和统计人员及主要研究者共同进行确认，并进行各分析集的人群划分，然后进行数据锁定。锁定后的数据或文件不再做改动。数据锁定之后发现的问题，经确认后在统计分析程序中进行修正。保存质量控制的有关文件，如数据一 致性检查、数值范围和逻辑检查的原始记录、盲态审核时的原始记录、研究者与监查员间交流的疑问记录等。

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

Data Records: Data entered into the CRF must be checked with the original documents. Any research-related documents must be archived, including a list of identifying information of the subjects participating in the study. This list and the signed informed consent form are important documents in the document and are kept by the researcher. Documentation Archiving and Confidentiality Principles: Subjects (hospital) related documents must be archived in accordance with relevant Chinese laws. All research-related documents must be kept for at least 5 years after the end of the study. All subjects-related data, including identifying information and all personal medical information, should be treated as confidential documents and treated as such. Data verification procedures should be carried out in the strictest confidentiality. Before obtaining informed consent, each participant should be informed of the confidentiality of personal data, original data source verification, audit, electronic data processing and document transfer procedures. Members of the research working group should keep any relevant information and results in the study confidential, unless approved in advance, it is strictly prohibited to disclose these to anyone other than the participants in the study. Monitoring: Periodic monitoring of this study by the sponsor and the clinical research leader of the sponsor (Xiamen Hong'ai Hospital). Monitoring procedures include one or more on-site inspections before the start of the study, and regular mid-term on-site inspections. During the on-site inspection, the completion of the CRF entry, the compliance of the research plan and other quality management norms will be checked, and the CRF entry data will be compared with the original data source. Data entry and locking: Data entry and management are managed by EpiDdata 3.1. In order to ensure the accuracy of the data, two data administrators should independently enter and proofread, verify and modify the data until the two databases are completely consistent. The data administrator, statisticians and key researchers jointly complete the blind review of the data, find problems and modify them. After confirming that they are correct, the data administrator, statisticians and key researchers jointly confirm, and divide the population of each analysis set, and then perform data locking. The locked data or files will not be changed. Problems found after data locking will be corrected in the statistical analysis program after confirmation. Maintain relevant quality control documents, such as original records of data consistency checks, numerical range and logic checks, original records of blind audits, and records of questions exchanged between researchers and inspectors.

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：

  2026-01-14 18:01:42