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

注册号： Registration number：	ChiCTR2600121718
最近更新日期： Date of Last Refreshed on：	2026-04-02 08:24:27
注册时间： Date of Registration：	2026-04-02 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	面部整形术后镇痛单中心随机对照试验
Public title：	Single-center Randomized Controlled Trial of Postoperative Analgesia in Facial Plastic Surgery
注册题目简写：
English Acronym：
研究课题的正式科学名称：	面部整形术后镇痛单中心随机对照试验
Scientific title：	Single-center Randomized Controlled Trial of Postoperative Analgesia in Facial Plastic Surgery
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：	刘徽	研究负责人：	甘承
Applicant：	Hui Liu	Study leader：	Cheng Gan
申请注册联系人电话： Applicant telephone：	+86 159 1062 7718	研究负责人电话： Study leader's telephone：	+86 138 1000 2695
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：	ymauil@bjmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	gan_cheng2026@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：	中国北京市海淀区学院路38号	研究负责人通讯地址：	中国北京市石景山区八大处路33号
Applicant address：	No. 38, Xueyuan Road, Haidian District, Beijing, China	Study leader's address：	No. 33, Baogushui Road, Shijingshan District, Beijing, 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：	北京大学
Applicant's institution：	Peking University
研究负责人所在单位：	中国医学科学院整形外科医院
Affiliation of the Leader：	Plastic Surgery Hospital, Chinese Academy of Medical Sciences

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：	(2025)注册第(361)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：	中国医学科学院整形外科医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-17 00:00:00
伦理委员会联系人：	裴晔
Contact Name of the ethic committee：	Ye Pei
伦理委员会联系地址：	中国北京市石景山区八大处路33号
Contact Address of the ethic committee：	No. 33, Baogushui Road, Shijingshan District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 5396 8034	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：

中国医学科学院整形外科医院

Primary sponsor：

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

中国北京市石景山区八大处路33号

Primary sponsor's address：

No. 33, Baogushui Road, Shijingshan District, Beijing, 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)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国医学科学院整形外科医院	具体地址：	中国北京市石景山区八大处路33号
Institution hospital：	Plastic Surgery Hospital, Chinese Academy of Medical Sciences	Address：	No. 33, Baogushui Road, Shijingshan District, Beijing, China

经费或物资来源：

横向经费

Source(s) of funding：

Contractual Research Funding

研究疾病：

面部整形手术

Target disease：

Facial Plastic Surgery

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：

术后疼痛管理是影响整形美容手术患者恢复质量与满意度的关键因素。研究表明，术后仍有相当比例的患者经历中至重度疼痛，疼痛控制不佳不仅会诱发不良的生理应激反应，还可能增加术后并发症的风险并延长康复时间。本研究拟开展一项单中心、随机对照临床试验，比较右旋布洛芬联合切口局部麻醉药浸润（多模式镇痛组，MMA组）与单纯切口局麻浸润（对照组）在门诊面部整形手术患者中的镇痛效果、术后情绪状态（焦虑、抑郁）、睡眠质量以及局部恢复进程等方面的差异。旨在系统评估“局部麻醉联合NSAIDs”策略在门诊整形手术术后镇痛管理中的有效性与安全性，并探索其在改善整体恢复体验方面的潜在获益。研究结果有望为减少阿片类镇痛药物的使用、优化日间整形美容手术的镇痛路径提供循证依据。

Objectives of Study：

Postoperative pain management is a critical determinant of recovery quality and patient satisfaction in aesthetic plastic surgery. Studies have shown that a considerable proportion of patients still experience moderate to severe pain after surgery. Inadequate pain control not only induces adverse physiological stress responses but may also increase the risk of postoperative complications and prolong recovery time. This study proposes to conduct a single-center, randomized controlled clinical trial to compare the analgesic efficacy, postoperative emotional states (anxiety and depression), sleep quality, and local recovery progress between multimodal analgesia (MMA group) using dexibuprofen combined with incisional local anesthetic infiltration versus incisional local anesthetic infiltration alone (control group) in outpatient facial plastic surgery patients. The aim is to systematically evaluate the efficacy and safety of the "local anesthesia combined with NSAIDs" strategy in postoperative analgesia management for outpatient plastic surgery, and to explore its potential benefits in improving overall recovery experience. The findings are expected to provide evidence-based support for reducing opioid analgesic use and optimizing analgesic pathways for day-case aesthetic plastic surgery procedures.

药物成份或治疗方案详述：

对照组：术中采用切口局部麻醉药物浸润，术后给予常规镇痛护理，但不常规预先使用预防性镇痛药物； MMA组（多模式镇痛组）：在术中同样给予切口局部麻醉药物浸润的基础上，术后预防性口服右旋布洛芬作为系统性镇痛干预。

Description for medicine or protocol of treatment in detail：

Control Group: Intraoperative incisional local anesthetic infiltration was administered, followed by routine postoperative analgesic nursing care without routine prophylactic use of preemptive analgesic medications. MMA Group (Multimodal Analgesia Group): Based on the same intraoperative incisional local anesthetic infiltration, prophylactic oral dexibuprofen was administered postoperatively as a systemic analgesic intervention.

纳入标准：

Inclusion criteria

1.Female, aged 18–65 years;
2.Scheduled for elective facial aesthetic plastic surgery, including but not limited to rhinoplasty, facial rhytidectomy and lifting, double eyelid surgery, chin augmentation, etc. (The formal trial will only include surgical procedures with a mean peak postoperative VAS score >=4 at 6 hours as identified in the pilot study);
3.American Society of Anesthesiologists (ASA) Physical Status Classification of Class I or II;
4.Estimated operative time within 2 hours, with planned intraoperative local anesthetic infiltration (may be supplemented with intravenous sedation or general anesthesia);
5. Willingness to take oral analgesic medications for postoperative pain control as needed, and ability to understand and comply with the analgesic protocol of this study;
6.Capacity to understand and cooperate with the pain assessment process, and ability to accurately express pain intensity using the Visual Analogue Scale (VAS);
7.Voluntary participation in this study, with signed written informed consent after full understanding of the study content, risks, and rights.

排除标准：

符合以下任一情况者不得纳入本研究： 1.已知对非甾体抗炎药（NSAIDs）如布洛芬，或对阿片类镇痛药物存在过敏或严重不良反应史者； 2.存在NSAIDs使用禁忌者，包括但不限于：活动性消化性溃疡或胃肠道出血病史；严重肝功能不全（如Child-Pugh C级）；严重肾功能不全（eGFR < 30 ml/min）；阿司匹林哮喘（三联症）； 3.有既往哮喘史，并曾因使用NSAIDs诱发支气管痉挛； 4.合并严重精神疾病或神经系统疾病，可能影响对疼痛的主观评估（如重度抑郁、认知功能障碍等）； 5.妊娠期或哺乳期女性（术前应排除妊娠）；或术后有妊娠计划但拒绝采取有效避孕措施者； 6.参与本研究前4周内接受过其他干预性临床试验者； 7.经研究者判断存在其他不适合参与本研究的医学或心理学因素者。

Exclusion criteria：

1.Known allergy or history of severe adverse reactions to non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or to opioid analgesics; 2.Presence of contraindications to NSAID use, including but not limited to: Active peptic ulcer disease or history of gastrointestinal bleeding; Severe hepatic impairment (e.g., Child-Pugh Class C); Severe renal impairment (eGFR < 30 ml/min); Aspirin-exacerbated respiratory disease (triad syndrome); 3.History of asthma with documented NSAID-induced bronchospasm; 4.Comorbid severe psychiatric or neurological disorders that may interfere with subjective pain assessment (e.g., major depression, cognitive dysfunction); 5.Pregnant or lactating women (pregnancy must be excluded preoperatively); or women with postoperative pregnancy plans who refuse to adopt effective contraceptive measures; 6.Participation in other interventional clinical trials within 4 weeks prior to enrollment in this study; 7.Other medical or psychological factors deemed by the investigator as unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-04-06 00:00:00至 To 2027-04-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-06 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	MMA组	样本量：	45
Group：	MMA Group	Sample size：	45
干预措施：	受试者在术中接受标准化切口局部麻醉药物浸润（如0.5%利多卡因或罗哌卡因联合肾上腺素）作为基础镇痛。术毕清醒后尽早（术后0–2小时内），由主治医生发放首剂口服右旋布洛芬300 mg（150 mg × 2片）。术后48小时内，建议每6小时口服150 mg（1片）右旋布洛芬，如6小时内疼痛超过预期患者可根据疼痛情况按需追加150 mg（1片）右旋布洛芬，每次服药间隔不小于4小时，24小时内总剂量不超过1200 mg(8片)。	干预措施代码：
Intervention：	Subjects in this group will receive standardized intraoperative incisional local anesthetic infiltration (e.g., 0.5% lidocaine or ropivacaine combined with epinephrine) as baseline analgesia. Upon regaining consciousness after surgery, the first dose of oral dexibuprofen 300 mg (150 mg × 2 tablets) will be administered by the attending physician as early as possible (within 0–2 hours postoperatively). During the 48-hour postoperative period, a maintenance dose of 150 mg (1 tablet) every 6 hours is recommended. If pain exceeds the expected level within any 6-hour interval, subjects may take an additional 150 mg (1 tablet) as needed based on their pain condition, with a minimum interval of 4 hours between each dose and a maximum daily dose not exceeding 1200 mg (8 tablets) within 24 hours. All medication administration (timing, dosage), VAS scores, and subjective relief assessments will be collected and recorded in real-time by the investigator through the WeChat-based Wenjuanxing survey system.	Intervention code：

组别：	对照组	样本量：	45
Group：	Control Group	Sample size：	45
干预措施：	术中同样给予局部麻醉药物浸润作为基础镇痛措施，但术后不常规给予预防性镇痛药物。对照组患者术后同样配发右旋布洛芬，但由其根据自身疼痛体验自主决定是否服药，研究人员不进行干预。患者被告知：当VAS评分≥4或出现明显不适时，可按需服用150 mg右旋布洛芬，每次间隔≥4小时。如疼痛剧烈（VAS≥8）或右旋布洛芬效果不佳，可酌情给予其他常规救援镇痛药物。	干预措施代码：
Intervention：	The control group will likewise receive local anesthetic infiltration intraoperatively as the baseline analgesic measure, but no routine prophylactic postoperative analgesic medication will be administered. After surgery, patients in the control group will also be provided with dexibuprofen, but they may decide independently whether to take the medication according to their own pain experience, without intervention from the research staff. Patients will be instructed that when the VAS score is ≥4 or when obvious discomfort occurs, 150 mg dexibuprofen may be taken as needed, with a minimum dosing interval of 4 hours. If the pain becomes severe (VAS ≥8) or if dexibuprofen provides insufficient relief, other standard rescue analgesic medications may be administered at the investigator’s discretion.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国医学科学院整形外科医院	单位级别：	三甲
Institution hospital：	Plastic Surgery Hospital, Chinese Academy of Medical Sciences	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	术后6小时疼痛强度峰值	指标类型：	主要指标
Outcome：	Peak postoperative pain intensity at 6 hours	Type：	Primary indicator
测量时间点：	术后6h	测量方法：	VAS评分
Measure time point of outcome：	6h postoperatively	Measure method：	VAS

指标中文名：	术后0–48小时疼痛暴露程度	指标类型：	次要指标
Outcome：	Cumulative pain exposure within 0–48 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0–48小时镇痛药物总用量	指标类型：	附加指标
Outcome：	Cumulative analgesic dosage within 0–48 hours after surgery	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件发生率	指标类型：	副作用指标
Outcome：	Incidence of adverse events	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总负性情绪评分	指标类型：	附加指标
Outcome：	Total negative affect score	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	睡眠质量评分	指标类型：	附加指标
Outcome：	Sleep quality score	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术区局部恢复	指标类型：	附加指标
Outcome：	Local surgical site recovery score	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后满意度评分	指标类型：	附加指标
Outcome：	Postoperative satisfaction score	Type：	Additional 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	18	岁 years
最大 Max age	65	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）：

本研究采用分层区组随机化方法进行分组。为控制年龄对术后疼痛感知及恢复反应的潜在混杂效应，以年龄（18–35岁、36–65岁）和手术性质（首次手术、修复手术）作为分层因素，将受试者划分为4个层次。各层内采用固定区组大小（区组含4例）进行区组随机化，以确保组间样本量的均衡性。随机序列由独立统计人员通过计算机程序预先生成，并针对各分层单独设定区组序列。待受试者完成知情同意签署并确认符合纳入标准后，研究者通过临床研究中心的电子随机分配系统获取分组信息。随机化按1:1比例分配至MMA组与对照组。

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

This study employed a stratified block randomization method for group allocation. To control for the potential confounding effect of age on postoperative pain perception and recovery response, age (18–35 years and 36–65 years) and surgery type (primary surgery and revision surgery) were used as stratification factors, dividing participants into four strata. Within each stratum, a fixed block size (4 participants per block) was applied to ensure balanced sample sizes between groups. The randomization sequence was pre-generated by an independent statistician using a computer program, with block sequences specified separately for each stratum. After participants provided informed consent and were confirmed eligible, investigators obtained individual group assignments through the electronic randomization system established at the clinical center. Randomization was conducted in a 1:1 ratio (MMA group : control group).

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：	无
Blinding：	None

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：	本研究的数据采集与管理采用 CRF + EDC 双轨模式。其中，病例报告表（CRF）用于规范记录基线资料、手术信息、不良事件及各访视医学观察数据，由CRC统一录入电子病例报告表（eCRF）。电子数据采集系统（EDC）则基于互联网平台实现，包括微信端问卷星小程序（类似ResMan模式）和eCRF系统：患者通过微信每日填写疼痛评分、服药记录、睡眠及满意度等信息，系统自动生成时间戳和唯一识别码（手机号绑定）；研究人员同步录入医学数据。系统具备字段校验、逻辑核查、缺失提醒、审计追踪、权限控制和自动备份功能，确保数据完整、可追溯与安全存储。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The study adopts a dual-track data collection and management model combining CRF and EDC. The Case Report Form (CRF) is used to standardize the recording of baseline data, surgical information, adverse events, and medical observations at each study visit, with all data uniformly entered into the electronic Case Report Form (eCRF) by the Clinical Research Coordinator (CRC). The Electronic Data Capture (EDC) system is implemented through an internet-based platform, including the WeChat-based Wenjuanxing mini-program (similar to the ResMan model) and the eCRF system. Patients complete daily entries via WeChat, including pain scores, medication use, sleep quality, and satisfaction data. The system automatically generates timestamps and a unique subject identifier linked to the participant’s mobile phone number, while investigators simultaneously enter medical data. The system is equipped with field validation, logical checks, missing-data alerts, audit trails, access control, and automatic backup functions, thereby ensuring data integrity, traceability, and secure storage.
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：	2026-04-02 08:24:22