ChiCTR2500110411 版本V1.0 版本创建时间2025/10/13 17:24:25 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：

 ChiCTR2500110411 

最近更新日期：

Date of Last Refreshed on：

 2025-10-13 17:24:21 

注册时间：

Date of Registration：

 2025-10-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经颅直流电刺激对术前睡眠障碍结、直肠患者术后疼痛的影响：前瞻性、随机、双盲、对照研究

Public title：

Effect of Transcranial Direct Current Stimulation on Postoperative Pain in Patients Undergoing Radical Resection for Colon Cancer and Rectal Cancer with Preoperative Sleep Disturbance: A Prospective, Randomized, Double-Blind, Controlled Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经颅直流电刺激对术前睡眠障碍结、直肠患者术后疼痛的影响：前瞻性、随机、双盲、对照研究

Scientific title：

Effect of Transcranial Direct Current Stimulation on Postoperative Pain in Patients Undergoing Radical Resection for Colon Cancer and Rectal Cancer with Preoperative Sleep Disturbance: A Prospective, Randomized, Double-Blind, Controlled 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：

朱贞燕 

研究负责人：

史静 

Applicant：

Zhu zhenyan 

Study leader：

Shi Jing 

申请注册联系人电话：

Applicant telephone：

 +86 136 2856 0952

研究负责人电话：

Study leader's
telephone：

+86 186 8503 4016

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：

 1054709360@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 315585290@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：

中国贵州省贵阳市云岩区贵医街28号

研究负责人通讯地址：

中国贵州省贵阳市云岩区贵医街28号

Applicant address：

No. 28, Guiyi Street, Yunyan District, Guiyang City, Guizhou Province, ChinaNo. 28, Guizhi Street, Yunyan District, Guiyang City, Guizhou Province, China

Study leader's address：

No. 28, Guiyi Street, Yunyan District, Guiyang City, Guizhou Province, ChinaNo. 28, Guizhi Street, Yunyan District, Guiyang City, Guizhou 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：

贵州医科大学附属医院

Applicant's institution：

Affiliated Hospital of Guizhou Medical University

研究负责人所在单位：

贵州医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guizhou 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：

 2025125K

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：

贵州医科大学附属医院研究者发起临床研究伦理委员会

Name of the ethic committee：

Ethics Committee for Researcher-Initiated Clinical Studies, Affiliated Hospital of Guizhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-26 00:00:00

伦理委员会联系人：

吴林丽

Contact Name of the ethic committee：

Wu Linli

伦理委员会联系地址：

中国贵州省贵阳市云岩区贵医街28号

Contact Address of the ethic committee：

No. 28, Guiyi Street, Yunyan District, Guiyang City, Guizhou Province, ChinaNo. 28, Guizhi Street, Yunyan District, Guiyang City, Guizhou Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 851 8675 2685

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：

贵州医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guizhou Medical University

研究实施负责（组长）单位地址：

中国贵州省贵阳市云岩区贵医街28号

Primary sponsor's address：

No. 28, Guiyi Street, Yunyan District, Guiyang City, Guizhou Province, ChinaNo. 28, Guizhi Street, Yunyan District, Guiyang City, Guizhou 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)：

贵州省

市(区县)：

贵阳市

Country：

China

Province：

guizhou

City：

guiyang

单位(医院)：

贵州医科大学附属医院

具体地址：

中国贵州省贵阳市云岩区贵医街28号

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Address：

No. 28, Guiyi Street, Yunyan District, Guiyang City, Guizhou Province, ChinaNo. 28, Guizhi Street, Yunyan District, Guiyang City, Guizhou Province, China

经费或物资来源：

贵州医科大学附属医院院内资助

Source(s) of funding：

Intra-hospital funding of the Affiliated Hospital of Guizhou Medical UniversityIntra-hospital funding of the Affiliated Hospital of Guizhou Medical University

研究疾病：

术后疼痛  

Target disease：

Postoperative 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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索围术期应用tDCS 能否改善患者睡眠及降低术后中、重度疼痛的发生率。  

Objectives of Study：

To explore whether the application of tDCS during the perioperative period can improve patients' sleep and reduce the incidence of moderate to severe postoperative pain.

药物成份或治疗方案详述：

手术前一天上午，研究小组的一名成员从择期手术名单中确定了潜在 参与者，进行PSQI睡眠评分和焦虑、抑郁评分后签署知情同意书、静脉采血（后续生物组学测定），再按分组情况进行第1次tDCS刺激或假刺激：通过放置在盐水浸泡的海绵中的 2个电极进行。电极由弹性帽固定，阳极在左侧背外侧前额叶皮层 （DLPFC）上、阴极放置在右侧眶上额叶（根据国际10-20 EEG系统定位），然后将阴、阳两极同时连接到主机。试验组（tDCS 组）：患者接受 2 mA tDCS，持续 20 分钟，开始时电流的上升阶段为 30 秒，结束时为 30 秒的下降阶段。对照组（假tDCS组）: 患者在每次疗程开始时仅接受 30 秒的电流上升阶段和 30 秒的下降阶段，中间20分钟内没有 2 mA 的恒定电流持续刺激。 手术当天入手术室后采用利兹睡眠评估量表（LSEQ）行睡眠评估后，行第2次tDCS刺激或假刺激，待刺激结束后常规开展麻醉和手术；术后进入麻醉术后恢复室（PACU）立即行第3次tDCS刺激或假刺激，采静脉血（后续生物组学测定），每次行tDCS刺激时，详细记录患者有无不良反应并记录，3次刺激结束后，请患者猜测出自己所接受的是真刺激还是假刺激（以减少心里安慰效应所产生的偏倚）。 术后6h、12h、24h、48h、72h内在病房进行疼痛数字等级评定量表（numerical rating scale， NRS）评分，包括静息时、运动/咳嗽时最强疼痛评分（由0到10共11个数组组成，0表示无痛，10表示剧痛；当静息NRS评分≥4分时进行补救镇痛：曲马多100mg肌注和氟比洛芬酯50mg静脉滴注，根据患者情况可重复使用，并记录首次行补救镇痛的时间及24h、48h、72h小时内累计补救镇痛次数。 术后第1天采用利兹睡眠评估量表（LSEQ）行睡眠评估。 记录术后24h、48h、72h内恶心、呕吐的情况：采用VAS评分量化恶心严重程度：轻度1 – 4分，中度5 – 6分，重度7 – 10分）；呕吐以24h、48h、72h内累计次数计算。根据受试者恶心和呕吐的严重程度，可以提供止吐药并记录。 术后72h进行恢复质量评估（QoR-15恢复质量评估量表）及镇痛满意度调查。 出院时记录术后住院天数及该时间段患者是否出现发热，术后是存在新出现的肩部疼痛、下肢疼痛或麻木，若有记录其持续时间； 术后30天通过电话随访睡眠情况（失眠严重程度指数量表：Insomnia Severity Index, ISI）、疼痛评分（NRS）及全因死亡率； 术后第90天，通过电话随访患者疼痛评分（NRS）。 

Description for medicine or protocol of treatment in detail：

The morning before the surgery, one member of the research team selected potential participants from the list of scheduled surgeries, conducted PSQI sleep assessment and anxiety and depression scoring, signed the informed consent form, collected venous blood (for subsequent bioinformatics analysis), and then performed the first tDCS stimulation or sham stimulation according to the group allocation: using two electrodes placed in a saltwater-soaked sponge. The electrodes were fixed by an elastic cap, with the anode on the left dorsolateral prefrontal cortex (DLPFC) and the cathode on the right superior frontal gyrus (positioned according to the international 10-20 EEG system), and then the two electrodes were simultaneously connected to the host. Experimental group (tDCS group): patients received 2 mA tDCS for 20 minutes, with an initial current rise phase of 30 seconds and a final 30-second decline phase. Control group (sham tDCS group): patients only received a 30-second current rise phase and 30-second decline phase at the beginning of each treatment session, with no 2 mA constant current stimulation for the remaining 20 minutes. After entering the operating room on the day of the surgery, the sleep assessment was conducted using the Leeds Sleep Evaluation Questionnaire (LSEQ), followed by the second tDCS stimulation or sham stimulation. After the stimulation, routine anesthesia and surgery were performed; after the surgery, the patient was immediately transferred to the anesthesia postoperative recovery room (PACU) for the third tDCS stimulation or sham stimulation, and venous blood was collected (for subsequent bioinformatics analysis). During each tDCS stimulation, adverse reactions of the patient were recorded and noted, and after the three stimulations, the patient was asked to guess whether they received the real stimulation or the sham stimulation (to reduce the bias caused by psychological placebo effect). Pain numerical rating scale (NRS) scores were recorded in the ward at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the surgery, including the strongest pain score at rest and during movement/coughing (composed of 11 categories from 0 to 10, with 0 indicating no pain and 10 indicating severe pain; if the resting NRS score was >= 4, rescue analgesia was administered: 100 mg tramadol intramuscular injection and 50 mg flurbiprofen axetil intravenous drip, which could be repeated based on the patient's condition, and the time of the first rescue analgesia was recorded and the cumulative number of rescue analgesia within 24 hours, 48 hours, and 72 hours was calculated). On the first day after the surgery, the sleep assessment was conducted using the Leeds Sleep Evaluation Questionnaire (LSEQ). The occurrence of nausea and vomiting within 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours after the surgery was recorded: the severity of nausea was quantified using the VAS score: mild 1 - 4 points, moderate 5 - 6 points, severe 7 - 10 points); vomiting was calculated based on the cumulative number within 24 hours, 48 hours, and 72 hours. Based on the severity of nausea and vomiting of the subjects, antiemetic drugs could be provided and recorded. At 72 hours after the surgery, the recovery quality assessment (QoR-15 recovery quality assessment questionnaire) and analgesic satisfaction survey were conducted. At discharge, the number of postoperative hospital days and whether the patient had fever during this period were recorded. New shoulder pain, lower limb pain or numbness that occurred after the surgery were recorded and their duration was noted. At 30 days after the surgery, the sleep situation (Insomnia Severity Index, ISI), pain score (NRS), and all-cause mortality were followed up by telephone. At the 90th day after the surgery, the pain score (NRS) was followed up by telephone. 

纳入标准：

入组受试者必须满足以下全部条件： ①拟全身麻醉下择期行“腹腔镜下结肠癌或直肠癌根治术”患者； ②年龄≥18岁； ③ASA分级I-III级； ④意识清楚、具备行为能力。 ⑤术前存在睡眠障碍：匹兹堡睡眠质量指数（PSQI）评分≥7分

Inclusion criteria

The enrolled subjects must meet all of the following conditions: 1 Patients scheduled for elective "laparoscopic radical resection of colon or rectal cancer" under general anesthesia; 2 Age >= 18 years; 3 ASA classification I-III; 4 Clear consciousness and ability to act; 5 Preoperative sleep disorder: Pittsburgh Sleep Quality Index (PSQI) score >= 7 points

排除标准：

① 听力障碍，不能配合完成测试； ② 中枢神经系统疾病史遗留语言或智力障碍者； ③ 存在tDCS禁忌症（如颅骨缺损或皮肤损伤等）； ④ 颅内及附近部位有金属或电子植入器件的患者：如脑起搏器、脑部血管夹、心脏起搏器等； ⑤ 癫痫病史、皮肤破损，患有严重心肺、肾脏、肝脏疾病、怀孕或有药物滥用史（包括饮酒）者； ⑥ 慢性疼痛综合征、长期使用阿片类药物或镇静剂（>3个月）； ⑦ 严重精神疾病（如抑郁症、精神分裂症）； ⑧ 无法理解睡眠及疼痛评分不能配合研究； ⑨ BMI<15kg/m2或BMI>35kg/m2； ⑩ 对阿片类药物、非甾体抗炎药 （NSAID） 或止吐药过敏或禁忌。

Exclusion criteria：

1 Hearing impairment, unable to complete the test as required; 2 Individuals with a history of central nervous system diseases who have developed language or intellectual impairments; 3 Those with contraindications for tDCS (such as skull defects or skin injuries); 4 Patients with metal or electronic implants in the brain or nearby areas: such as brain pacemakers, cerebral vascular clips, cardiac pacemakers, etc.; 5 History of epilepsy, skin damage, severe heart, lung, kidney, or liver diseases, pregnancy, or history of drug abuse (including alcohol use); 6 Chronic pain syndromes, long-term use of opioid drugs or sedatives (>3 months); 7 Severe mental disorders (such as depression, schizophrenia); 8 Unable to understand sleep and pain scores and unable to cooperate with the research; 9 BMI < 15 kg/m2 or BMI > 35 kg/m2; 10 Allergic or contraindicated to opioid drugs, non-steroidal anti-inflammatory drugs (NSAIDs), or antiemetic drugs.

研究实施时间：

Study execute time：

从 From 2025-09-26 00:00:00至 To 2026-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-13 00:00:00 至 To 2026-06-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 158

Group：

Intervention group (tDCS group)

Sample size：

干预措施：

患者接受 2 mA tDCS，持续 20 分钟，开始时电流的上升阶段为 30 秒，结束时为 30 秒的下降阶段。

干预措施代码：

Intervention：

Patients received 2 mA tDCS for 20 minutes. The current rose for 30 seconds at the beginning and then dropped for 30 seconds at the end.

Intervention code：

组别：

对照组（sham tDCS group）

样本量：

 158

Group：

Control group (sham tDCS group):

Sample size：

干预措施：

患者在每次疗程开始时仅接受 30 秒的电流上升阶段和 30 秒的下降阶段，中间20分钟内没有 2 mA 的恒定电流持续刺激。

干预措施代码：

Intervention：

At the start of each treatment session, patients only received a 30-second current rise and a 30-second current drop, with no constant 2 mA stimulation for the remaining 20 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州省 

市(区县)：

 贵阳市 

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

 贵州医科大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后24h内患者中、重度疼痛的发生率（定义为数字评定量表 NRS ≥ 4分）

指标类型：

主要指标

Outcome：

The incidence of moderate to severe pain in patients within 24 hours after the operation (defined as a Numerical Rating Scale NRS score of 4 or higher).

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次补救镇痛距离手术结束的时间

指标类型：

次要指标

Outcome：

The first postoperative analgesic administration was administered at a time immediately following the completion of the surgery.

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24h、48h、72h内累计使用补救镇痛的次数；

指标类型：

次要指标

Outcome：

The cumulative number of times of remedial analgesia used within 24 hours, 48 hours and 72 hours after the operation.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术前1晚及术后第1晚睡眠质量

指标类型：

次要指标

Outcome：

Sleep quality the night before the surgery and the first night after the surgery

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24h、48h、72h内恶心、呕吐的情况（轻、中、重度）

指标类型：

次要指标

Outcome：

The occurrence of nausea and vomiting within 24 hours, 48 hours, and 72 hours after the operation (mild, moderate, severe)

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72h恢复质量及镇痛满意度；

指标类型：

次要指标

Outcome：

Postoperative 72-hour recovery quality and satisfaction with pain relief

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后住院天数、发热患者的比例

指标类型：

次要指标

Outcome：

The number of days spent in hospital after the surgery and the proportion of patients with fever

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后新出现的肩部疼痛、下肢疼痛或麻木的发生率及其持续时间

指标类型：

次要指标

Outcome：

The incidence and duration of new shoulder pain, lower limb pain or numbness that occurred after the surgery

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30天亚急性疼痛的发生率、睡眠质量及全因死亡率

指标类型：

次要指标

Outcome：

The incidence of subacute pain, sleep quality and all-cause mortality 30 days after the surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后第90天慢性疼痛的发生率

指标类型：

次要指标

Outcome：

The incidence of chronic pain on the 90th day after the surgery

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48h、72h内患者中、重度疼痛的发生率

指标类型：

次要指标

Outcome：

The incidence rates of moderate to severe pain in patients within 48 hours and 72 hours after the operation

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：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

Destruction after use

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 90 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）：

采用计算机生成的随机数字表，将每组受试者以1：1的比例集中随机分配至tDCS组或假tDCS组。

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

Using a computer-generated random number table, each group of subjects was randomly assigned to the tDCS group or the sham tDCS group in a 1:1 ratio.

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：

受试者、外科医生、数据收集者、评估者及数据统计分析人员处于盲态，确保整个研究过程不受主观因素干扰。

Blinding：

The subjects, surgeons, data collectors, evaluators and data statisticians were all kept in a blinded state to ensure that the entire research process was not influenced by subjective factors

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）：

不公开原始数据

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

Not disclosing the original data

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：

1．病例报告表的记录要求 全部病例，无论是符合研究方案的病例还是脱落病例，均应按本方案规定，在完整准确书写原始记录的基础上，认真填写病例报告表。负责人对本中心研究数据的真实性负责。 病例报告表中记录的实验室检查数据或描述，要与原始记录中的原始检验报告核对无误，监察员应对此负责。有关填表说明，见原始记录、病例报告表。 2．数据库的建立 数据录入采用电子和纸质CRF双份录入；临床研究过程中数据管理员与电子CRF进行独立核查，对录入不一致的结果，对照电子病例系统逐项核查、更正。项目负责人随机抽取若干份病例报告表和数据库中的数据进行人工比较，以确保数据库中的数据与原始CRF表中的结果一致。

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

1. Record Requirements for Case Report Forms For all cases, whether they are in accordance with the research protocol or dropped-out cases, they should be filled out on the case report form based on the complete and accurate original records as stipulated in this protocol. The person in charge is responsible for the authenticity of the research data of this center. The laboratory test data or descriptions recorded in the case report form should be verified to be consistent with the original test reports in the original records. The monitor is responsible for this. For the filling instructions, see the original records and case report forms. 2. Database Establishment Data entry is conducted using both electronic and paper CRFs. During the clinical research process, the data manager independently checks the data with the electronic CRF. For inconsistent results, the data should be verified item by item against the electronic case system and corrected. The project leader randomly selects several case report forms and data from the database for manual comparison to ensure that the data in the database is consistent with the results in the original CRF forms.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-13 17:24:21