简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
超声引导腹侧腹平面阻断联合静脉注射镇痛，用于老年胃切除患者术后疼痛控制：一种双盲随机对照试验方案
下载XML文档

注册号：

Registration number：

 ChiCTR2600124616 

最近更新日期：

Date of Last Refreshed on：

 2026-05-14 14:42:44 

注册时间：

Date of Registration：

 2026-05-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

超声引导腹侧腹平面阻断联合静脉注射镇痛，用于老年胃切除患者术后疼痛控制：一种双盲随机对照试验方案

Public title：

Ultrasound-Guided Transversus Abdominis Plane Block Combined With Intravenous Analgesia for Postoperative Pain Control in Elderly Patients Undergoing Gastrectomy: A Double-Blind Randomized Controlled Trial Protocol

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声引导腹侧腹平面阻断联合静脉注射镇痛，用于老年胃切除患者术后疼痛控制：一种双盲随机对照试验方案

Scientific title：

Ultrasound-Guided Transversus Abdominis Plane Block Combined With Intravenous Analgesia for Postoperative Pain Control in Elderly Patients Undergoing Gastrectomy: A Double-Blind Randomized Controlled Trial Protocol

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：

马智杰 

研究负责人：

马智杰 

Applicant：

Zhijie Ma 

Study leader：

Zhijie Ma 

申请注册联系人电话：

Applicant telephone：

 +86 139 1995 3272

研究负责人电话：

Study leader's
telephone：

+86 181 9313 9227

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：

 190805203@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 190805203@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：

中国甘肃省兰州市城关区翠英门82号

研究负责人通讯地址：

中国甘肃省兰州市城关区翠英门82号

Applicant address：

No. 82, Cu Yingmen, Chengguan District, Lanzhou, Gansu, China

Study leader's address：

No. 82, Cu Yingmen, Chengguan District, Lanzhou, Gansu, 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：

兰州大学第二医院

Applicant's institution：

The Second Hospital of Lanzhou University

研究负责人所在单位：

兰州大学第二医院

Affiliation of the Leader：

The Second Hospital of Lanzhou 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：

 2026A-609

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：

兰州大学第二医院（第二临床医学院）

Name of the ethic committee：

The Second Hospital of Lanzhou University (Second Clinical Medical College)

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-17 00:00:00

伦理委员会联系人：

闫学良

Contact Name of the ethic committee：

Xueliang Yan

伦理委员会联系地址：

中国甘肃省兰州市城关区翠英门82号

Contact Address of the ethic committee：

No. 82, Cu Yingmen, Chengguan District, Lanzhou, Gansu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 931 894 3370

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：

兰州大学第二医院

Primary sponsor：

The Second Hospital of Lanzhou University

研究实施负责（组长）单位地址：

中国甘肃省兰州市城关区翠英门82号

Primary sponsor's address：

No. 82, Cu Yingmen, Chengguan District, Lanzhou, Gansu, 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)：

甘肃

市(区县)：

Country：

China

Province：

Gansu

City：

单位(医院)：

兰州大学第二医院

具体地址：

中国甘肃省兰州市城关区翠英门82号

Institution
hospital：

The Second Hospital of Lanzhou University

Address：

No. 82, Cu Yingmen, Chengguan District, Lanzhou, Gansu, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

研究疾病：

无  

Target disease：

None

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：

该研究的核心目的是评估在择期行根治性胃切除术的老年患者中，将超声引导腹横肌平面阻滞（TAPB）联合标准化舒芬太尼静脉自控镇痛（PCIA），相比安慰剂阻滞联合相同舒芬太尼 PCIA 方案，在改善术后疼痛、减少阿片类药物使用、降低术后谵妄发生率等方面的有效性与安全性，同时探究该联合镇痛方案对患者临床恢复指标的影响，最终为老年胃切除术患者围手术期多模式镇痛策略的制定提供高质量的临床证据。  

Objectives of Study：

The core aim of the study was to evaluate the efficacy of ultrasound-guided transversus abdominis plane block (TAPB) combined with standardized sufentanil for patient-controlled intravenous analgesia (PCIA) in elderly patients undergoing elective radical gastrectomy, and to evaluate the efficacy of this method, the efficacy and safety of placebo blockade combined with the same sufentanil PCIA regimen in improving postoperative pain, reducing opioid use, and reducing the incidence of postoperative delirium compared with placebo blockade combined with the same sufentanil PCIA regimen, at the same time, the influence of the combined analgesia scheme on the clinical recovery indicators of patients is explored, and finally high-quality clinical evidence is provided for the formulation of perioperative multimodal analgesia strategies for elderly patients undergoing gastrectomy.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.存在凝血功能障碍或使用抗凝药物，为TAPB禁忌； 2.穿刺部位存在感染； 3.对局麻药或舒芬太尼过敏； 4.严重肝、肾功能不全； 5.术前存在慢性疼痛或长期使用阿片类药物； 6.术前存在认知功能障碍，无法完成CAM/CAM-ICU评估； 7.体重指数（BMI）> 35 kg/m^2； 8.术中转为开胸-开腹联合入路； 9.正在参与其他干预性临床试验。

Exclusion criteria：

1.Coagulopathy or anticoagulant use contraindicating TAPB 2.Infection at puncture site 3.Allergy to local anesthetics or sufentanil 4.Severe hepatic or renal dysfunction 5.Preexisting chronic pain or long-term opioid use 6.Cognitive impairment precluding CAM/CAM-ICU assessment 7.BMI >35 kg/m^2 (poor ultrasound visualization) 8.Conversion to open–thoracoabdominal approach intraoperatively 9.Participation in another interventional trial

研究实施时间：

Study execute time：

从 From 2026-05-19 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-20 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 83

Group：

Intervention group

Sample size：

干预措施：

全身麻醉诱导后、切皮前，在超声引导下于双侧腹横肌平面注射0.375%罗哌卡因各20 mL（共40 mL）。

干预措施代码：

Intervention：

After induction of general anesthesia and before skin incision, 0.375% ropivacaine 20 mL was injected into bilateral transversus abdominis muscle under ultrasound guidance (40 mL in total).

Intervention code：

组别：

对照组

样本量：

 83

Group：

Control group

Sample size：

干预措施：

采用相同的超声定位和针刺步骤，但不注射药物或仅注射≤1 mL生理盐水。

干预措施代码：

Intervention：

The same ultrasound localization and needling steps were used, but no drug was injected or only ≤1 mL saline was injected.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 甘肃 

市(区县)：

 兰州 

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

 兰州大学第二医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Hospital of Lanzhou University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后 48 小时静息视觉模拟评分（VAS）的曲线下面积（AUC）

指标类型：

主要指标

Outcome：

Area under the curve (AUC) of resting visual analogue scale (Vas) at 48 hours after surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后 48 小时活动状态视觉模拟评分（VAS）的曲线下面积（AUC）

指标类型：

主要指标

Outcome：

Area under the curve (AUC) of active state visual analogue scale (Vas) at 48 hours after surgery

Type：

Primary 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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 65 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）：

该研究采用计算机生成随机序列结合密封信封法的随机化方法，同时搭配固定区组随机化策略，实现了随机分组与分配隐藏，具体操作细节如下： 随机序列生成：由不参与患者临床诊疗的独立统计师完成，采用区组大小为 4 和 6 的随机置换方式生成计算机随机序列，避免分组规律被预判，保证组间样本量均衡。 分配隐藏：采用按顺序编号的不透明密封信封（SNOSE） 进行分配隐藏，将生成的随机分组结果置入信封并密封，从根本上防止分组信息提前泄露。 随机化执行：在患者全身麻醉诱导后，由不参与术后结局评估的麻醉医生打开密封信封，按照信封内的分组结果为患者实施对应的干预（TAPB 或假阻滞），进一步减少选择偏倚。 该随机方法确保了研究对象被 1:1 随机分配至干预组和对照组，且全程保证分配隐藏的完整性，符合随机对照试验的设计规范

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

In this study, a randomization method combining computer-generated random sequence with sealed envelope method and fixed block randomization strategy is used to achieve random grouping and allocation concealment. The specific operation details are as follows: Random sequence generation: completed by an independent statistician who is not involved in the clinical diagnosis and treatment of patients. A random permutation method with block sizes of 4 and 6 is used to generate a computer random sequence to avoid the grouping rule being prejudged, to ensure a balanced sample size between groups. Allocation hiding: an opaque sealed envelope (SNOSE) with sequential numbering is used for allocation hiding, and the generated random grouping results are placed into the envelope and sealed to fundamentally prevent the premature leakage of grouping information. Randomization was performed: after the patient's induction of general anesthesia, a sealed envelope was opened by an anesthesiologist who was not involved in the postoperative outcome assessment, and the corresponding intervention (TAPB or sham block) was implemented for the patient according to the outcome within the envelope, further reducing selection bias. The randomized method ensures that the study subjects are randomly assigned to the intervention group and the control group 1:1, and the integrity of the allocation concealment is ensured throughout the process, which conforms to the design specifications of the randomized controlled trial

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：

该研究采用双盲设计（研究者、研究对象、结局评估者等关键人员均设盲），是随机对照试验中最高等级的盲法类型，为保证盲法的有效性，研究设计了标准化的操作流程、用药制备、人员分工等一系列严格的盲法实施措施，同时配套盲法完整性验证环节，具体设计和实施细节如下： 一、盲法覆盖人群 试验全程对患者、术后结局评估者、研究主研人员、护士、统计分析师设盲；仅负责制备药物 / 操作的独立人员、开启随机信封的麻醉医生知晓单次分组信息，且该类人员均不参与术后任何评估与数据分析，从人员层面杜绝盲法泄露。 二、核心盲法实施措施 1. 操作层面：两组操作流程完全一致，仅核心干预有差异 干预组（TAPB）和对照组（假阻滞）执行相同的皮肤准备、超声探头放置、针具定位操作；对照组仅做「无局麻药注射 /≤1mL 生理盐水注射 + 针具不穿透腹横肌平面」的假操作，模拟推注的压力感，让患者和操作执行者无法通过操作感受区分组别。 2. 用药层面：独立人员制备，统一耗材与外观 所有用于阻滞的注射器、药物均由不参与试验评估的独立药师 / 护士制备，保证两组耗材的外观、规格完全一致；局麻药 / 生理盐水的制备过程全程保密，避免其他人员通过用药环节获知分组。 3. 镇痛层面：PCIA 方案完全标准化，无组别差异 两组术后均使用参数完全相同的舒芬太尼 PCIA（背景输注 2mL/h、冲击剂量 2mL、锁定 10 分钟，且不允许调整基础速率），从术后镇痛方案上消除组别辨识度，避免因镇痛操作差异破盲。 三、盲法完整性的评估与验证 评估时间：分别在术后 48 小时（干预结束时） 和研究终点进行盲法完整性检查； 评估工具：采用经验证的盲法指数（如 James Blinding Index） +专用盲法调查问卷（参考同类经典试验方案设计），对参与评估的研究人员进行调查，判断其是否能推测出患者的实际分组； 结果应用：若盲法完整性评估显示存在破盲风险，会及时采取校正措施，若已发生破盲，相关病例会按试验方案进行处理（如纳入敏感性分析）。 四、盲法维持的配套细节 试验全程对研究人员进行盲法操作专项培训，明确破盲的禁忌与上报流程；所有试验记录中不标注患者具体组别，仅用随机编号代替；数据统计分析阶段采用盲态分析，直至试验结束、完成数据核查后才进行揭盲。 该双盲设计有效规避了执行偏倚（研究者操作的主观差异）和评估偏倚（结局判断的主观偏差），最大程度保证了试验结果的客观性和可靠性，也是该研究的重要设计优势之一。

Blinding：

The study was conducted in a double-blind design (researchers, study subjects, outcome assessors, and other key personnel were blinded) and was the highest level of blinding type in a randomized controlled trial, a series of strict blind implementation measures were designed, such as standardized operation process, drug preparation, division of labor, and supporting blind integrity verification. The specific design and implementation details are as follows: I. Blind coverage of the population The trial was blinded to patients, post-operative outcome assessors, researchers, nurses, and statistical analysts Only the independent personnel responsible for the preparation of the drug/procedure, the anesthesiologist who opened the random envelope, were aware of the single-session grouping information, and none of these personnel were involved in any post-operative evaluation or data analysis, preventing blind leaks at the personnel level. II. Core measures for implementing blind law 1. Operational level: the operational procedures of the two groups were identical except for the core intervention The intervention group (TAPB) and the control group (Sham Block) performed the same skin preparation, ultrasound probe placement, and needle positioning procedures; The control group only performed a sham operation of"No local anesthetic injection/≤1 ml normal saline injection + the needle did not penetrate the transverse abdominal muscle plane" to simulate the pressure feeling of injection, the patient and the operator were unable to distinguish between the groups by the sensation of the manipulation. 2. Level of medication: independent preparation, uniform consumables and presentation All the syringes and drugs used for block were prepared by independent pharmacists/nurses who were not involved in the evaluation of the trial. The appearance and specifications of the two groups of consumables were completely consistent. The preparation process of local anesthetics/saline was kept confidential, to avoid other staff through the use of drugs to know the group. 3. Analgesia dimensions: the PCIA regimen was fully standardized with no group differences Both groups were treated postoperatively with Sufentanil PCIA (background infusion 2 ml/h, shock dose 2 ml, locked for 10 min, and no adjustment of basal rate allowed) with identical parameters, eliminating group discrimination from the postoperative analgesia protocol, and the use of Sufentanil PCIA (2 ml/h background infusion, 2 ml shock dose, locked for 10 min, and no adjustment of basal rate allowed) , to avoid blinding due to differences in analgesia procedures. III. Assessment and verification of blinding Assessment time: Blinded Integrity Monitoring was performed at 48 hours postoperatively (end of intervention) and at study end points, respectively; Assessment Tools: A validated Blinding Index (e.g. James Blinding Index) + a dedicated Blinding questionnaire (designed with reference to similar classical trial protocols) were used to survey the researchers involved in the assessment, to determine whether they could infer the actual grouping of patients; Results application: if Blinding Integrity Assessment showed that there was a risk of blinding, corrective measures would be taken in time. If blinding had occurred, related cases would be treated according to the trial protocol (such as included in sensitivity analysis) . Iv. Supporting details of blinding maintenance During the whole trial, special training was given to the researchers on blind operation, and the contraindications and reporting procedures for breaking blindness were clarified In the stage of statistical analysis, blind analysis was used until the end of the experiment and the completion of data verification. This double-blind design effectively avoided execution bias (subjective differences in investigator operations) and assessment bias (subjective bias in outcome judgment) , and ensured the objectivity and reliability of the trial results to the greatest extent, is also one of the important design strengths of the study.

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

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：

即时记录与补录要求 双重核查：独立人员交叉核对 常态化数据质控与疑问解决 严格的隐私保护与数据分离存储 数据留存与归档：满足法规要求 盲态数据管理：直至试验结束揭盲

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

Real-time record and addendum requirement Double checking: cross-checking by an independent person Normalization of data quality control and problem solving Strict privacy protection and separate data storage Data retention and archiving: meeting regulatory requirements Blind data management: Unblinding until trial completion

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：

  2026-05-14 14:42:37
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统