Effect of Buccal Acupuncture on catheter-related bladder irritation after Ureteroscopic lithotripsy

注册号:

Registration number:

ITMCTR2024000302

最近更新日期:

Date of Last Refreshed on:

2024-08-26

注册时间:

Date of Registration:

2024-08-26

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

颊针对输尿管镜碎石术术后导尿管相关膀胱刺激征的影响

Public title:

Effect of Buccal Acupuncture on catheter-related bladder irritation after Ureteroscopic lithotripsy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

颊针对输尿管镜碎石术术后导尿管相关膀胱刺激征的影响

Scientific title:

Effect of Buccal Acupuncture on catheter-related bladder irritation after Ureteroscopic lithotripsy

研究课题的正式科学名称简写:

Scientific title acronym:

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:

吴惠珍

研究负责人:

王东

Applicant:

Wu Huizhen

Study leader:

Wang Dong

申请注册联系人电话:

Applicant telephone:

+86 187 1916 5274

研究负责人电话:

Study leader's telephone:

+86 181 7737 9009

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:

1031699725@qq.com

研究负责人电子邮件:

Study leader's E-mail:

376553370@qq.com

申请单位网址(自愿提供):

Study leader's 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:

中国广西壮族自治区桂林市象山区新桥园路1号

研究负责人通讯地址:

中国广西壮族自治区桂林市象山区新桥园路1号

Applicant address:

No. 1 Xinqiao Yuan Road, Xiangshan District, Guilin City, Guangxi Zhuang Autonomous

Study leader's address:

No. 1 Xinqiao Yuan Road, Xiangshan District, Guilin City, Guangxi Zhuang Autonomous

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:

中国人民解放军联勤保障部队第九二四医院

Applicant's institution:

The 924th Hospital of the PLA Joint Logistics Support Force

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

桂医[2024]77号

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

中国人民解放军联勤保障部队第九二四医院伦理委员会

Name of the ethic committee:

Ethics Committee of the 924th Hospital of the PLA Joint Logistics Support Force

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/1 0:00:00

伦理委员会联系人:

罗兴

Contact Name of the ethic committee:

Luo Xing

伦理委员会联系地址:

中国广西壮族自治区桂林市象山区新桥园路1号

Contact Address of the ethic committee:

No. 1 Xinqiao Yuan Road, Xiangshan District, Guilin City, Guangxi Zhuang Autonomous Region, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 773 208 0702

伦理委员会联系人邮箱:

Contact email of the ethic committee:

kxb181@163.com

研究实施负责(组长)单位:

中国人民解放军联勤保障部队第九二四医院麻醉科

Primary sponsor:

Department of Anesthesiology,the 924th Hospital of the PLA Joint Logistics Support Force

研究实施负责(组长)单位地址:

中国广西壮族自治区桂林市象山区新桥园路1号

Primary sponsor's address:

No. 1 Xinqiao Yuan Road, Xiangshan District, Guilin City, Guangxi Zhuang Autonomous Region, 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):

广西壮族自治区

市(区县):

桂林

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

Guilin

单位(医院):

中国人民解放军联勤保障部队第九二四医院

具体地址:

中国广西壮族自治区桂林市象山区新桥园路1号

Institution
hospital:

The 924th Hospital of the PLA Joint Logistics Support Force

Address:

No. 1 Xinqiao Yuan Road, Xiangshan District, Guilin City, Guangxi Zhuang Autonomous Region, China

经费或物资来源:

自筹经费

Source(s) of funding:

Self-raising funding

研究疾病:

导尿管相关膀胱刺激征

研究疾病代码:

Target disease:

catheter-related bladder irritation

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

本研究的主要目的是通过观察择期行输尿管镜碎石患者术后导尿管相关膀胱刺激征(CRBD)的发生情况,验证围术期应用颊针疗法用于缓解CRBD的安全性及优越性。同时探讨麻醉复苏期颊针对输尿管镜碎石患者术后恶心呕吐、胃肠功能、疼痛、睡眠质量等术后恢复质量的影响。

Objectives of Study:

The primary objective of this study is to observe the incidence of catheter-related bladder discomfort (CRBD) in patients undergoing elective ureteroscopic lithotripsy and to assess the safety and efficacy of using buccal acupuncture to alleviate CRBD during the perioperative period. Additionally, the study aims to explore the impact of buccal acupuncture during the anesthetic recovery period on postoperative recovery quality, including nausea and vomiting, gastrointestinal function, pain, and sleep quality in patients undergoing ureteroscopic lithotripsy.

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患者自愿参加,且签署知情同意书;②年龄大于18岁;③拟行择期输尿管镜碎石术;④ ASAⅠ-Ⅲ级;⑤需要留置导尿管。

Inclusion criteria

① Patients voluntarily participate and sign the informed consent form; ② Age greater than 18 years; ③ Scheduled for elective ureteroscopic lithotripsy; ④ ASA I-III classification; ⑤ Requires indwelling catheter.

排除标准:

①PACU苏醒后无法沟通,合并认知功能障碍及PACU苏醒后发生谵妄;②穴位皮肤破损、有瘢痕者,腮腺炎患者;③术前合并神经源性膀胱;④ASA分级≥IV级,存在严重肝肾功能障碍;⑤术后计划进入ICU及非计划转入ICU;⑥对常规全身麻醉药物过敏,无法完成手术麻醉;⑦同期参与其他临床研究;⑧神经、精神疾病史或其他原因不能配合随访者。

Exclusion criteria:

① Inability to communicate upon recovery in the post-anesthesia care unit (PACU), accompanied by cognitive dysfunction and emergence delirium in the PACU. ② Presence of skin lesions or scarring at acupuncture points, or diagnosis of mumps. ③ Preoperative diagnosis of neurogenic bladder. ④ American Society of Anesthesiologists (ASA) Physical Status Classification of IV or higher, with severe hepatic or renal impairment. ⑤ Planned postoperative admission to the Intensive Care Unit (ICU) or unplanned transfer to the ICU. ⑥ Allergic reactions to standard general anesthetic agents, rendering the completion of surgical anesthesia impossible. ⑦ Concurrent participation in other clinical trials. ⑧ History of neurological or psychiatric disorders, or any other conditions that prevent compliance with follow-up.

研究实施时间:

Study execute time:

From 2024-08-31

To      2025-03-01

征募观察对象时间:

Recruiting time:

From 2024-08-31

To      2025-03-01

干预措施:

Interventions:

组别:

试验组,颊针组

样本量:

59

Group:

experimental group,buccal acupuncture treatment group

Sample size:

干预措施:

颊针组患者手术结束拔除气管导管后予颊针治疗(取穴位双侧骶穴、腰穴、下焦穴,留针30min)

干预措施代码:

D

Intervention:

Patients in the buccal acupuncture treatment group received buccal acupuncture therapy following extubation after surgery. The selected acupuncture points included bilateral sacral points, lumbar points, and lower abdominal points, with needles retained for 30 minutes.

Intervention code:

组别:

对照组

样本量:

59

Group:

control group

Sample size:

干预措施:

假针刺,即对照组患者手术结束拔除气管导管后予颊针组相同穴位处使用龙胆紫记号笔标记,并用套管针在穴位处加压,但不行针刺治疗(取穴位双侧骶穴、腰穴、下焦穴)

干预措施代码:

C

Intervention:

Sham acupuncture: Upon completion of surgery and extubation in the control group patients, Gentian violet marker was used to mark the same acupoints as those in the buccal acupuncture treatment group. Pressure was applied to these points with a stylet needle without actual needle insertion (the selected points include bilateral sacral points, lumbar points, and lower abdominal points).

Intervention code:

样本总量 Total sample size : 118

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

桂林

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

Guilin

单位(医院):

中国人民解放军联勤保障部队第九二四医院

单位级别:

三甲

Institution/hospital:

The 924th Hospital of the PLA Joint Logistics Support Force

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

Richmond躁动-镇静评分

指标类型:

次要指标

Outcome:

Richmond Agitation and Sedation Scale,RASS

Type:

Secondary indicator

测量时间点:

术后

测量方法:

Measure time point of outcome:

after surgery

Measure method:

指标中文名:

术后睡眠情况评估

指标类型:

次要指标

Outcome:

Assessment of Postoperative Sleep Quality

Type:

Secondary indicator

测量时间点:

术前1天,术后第 1天、第 2天

测量方法:

RCSQ评分

Measure time point of outcome:

One day before surgery, on the first postoperative day, and on the second postoperative day

Measure method:

Richards-Campbell Sleep Questionnaire,RCSQ

指标中文名:

针刺相关疼痛

指标类型:

副作用指标

Outcome:

acupuncture related pains

Type:

Adverse events

测量时间点:

术后48小时内

测量方法:

患者评估

Measure time point of outcome:

within 48 hours after surgery

Measure method:

assessment by patients

指标中文名:

术后恢复质量评估

指标类型:

次要指标

Outcome:

Assessment of Postoperative Recovery Quality

Type:

Secondary indicator

测量时间点:

术前1天,术后第 1天、第 2天

测量方法:

QoR-15量表

Measure time point of outcome:

One day before surgery, on the first postoperative day, and on the second postoperative day

Measure method:

QoR-15

指标中文名:

恶心呕吐以及胃肠功能恢复质量评估

指标类型:

次要指标

Outcome:

Assessment of Nausea, Vomiting, and Quality of Gastrointestinal Recovery

Type:

Secondary indicator

测量时间点:

术后即刻(0h)、术后1、2、6 、24、48h

测量方法:

视觉模拟量表(VAS)

Measure time point of outcome:

Immediate post-operation (0h), post-operation 1h, post-operation 2h, post-operation 6h, post-operation 24h

Measure method:

Visual Analog Scale, VAS

指标中文名:

针刺相关并发症

指标类型:

副作用指标

Outcome:

acupuncture related complications

Type:

Adverse events

测量时间点:

术后48小时内

测量方法:

临床观察

Measure time point of outcome:

within 48 hours after surgery

Measure method:

clinical observation

指标中文名:

术后并发症

指标类型:

次要指标

Outcome:

postoperative complications

Type:

Secondary indicator

测量时间点:

术后

测量方法:

临床观察

Measure time point of outcome:

after surgery

Measure method:

clinical observation

指标中文名:

术后首次下地活动时间

指标类型:

次要指标

Outcome:

first time of out-of-bed activity after surgery

Type:

Secondary indicator

测量时间点:

术后48小时内

测量方法:

临床观察

Measure time point of outcome:

within 48 hours after surgery

Measure method:

clinical observation

指标中文名:

术后满意度

指标类型:

次要指标

Outcome:

postoperative satisfaction

Type:

Secondary indicator

测量时间点:

术后第1天

测量方法:

视觉模拟量表(VAS)

Measure time point of outcome:

on the first postoperative day

Measure method:

The visual analog scale,VAS

指标中文名:

术后尿管相关膀胱刺激征(CRBD)发生分级

指标类型:

主要指标

Outcome:

Classification of Postoperative Catheter-Related Bladder Discomfort (CRBD)

Type:

Primary indicator

测量时间点:

术后即刻(0h)、术后1、2、6 、24、48h

测量方法:

临床观察

Measure time point of outcome:

Immediate post-operation (0h), post-operation 1h, post-operation 2h, post-operation 6h, post-operation 24h

Measure method:

clinical observation

指标中文名:

住院总费用

指标类型:

次要指标

Outcome:

Total hospitalization cost

Type:

Secondary indicator

测量时间点:

出院后

测量方法:

电子病历系统

Measure time point of outcome:

After discharge

Measure method:

Electronic Medical Record System

指标中文名:

术后首次进食时间

指标类型:

次要指标

Outcome:

first time of eating after surgery

Type:

Secondary indicator

测量时间点:

术后48小时内

测量方法:

临床观察

Measure time point of outcome:

within 48 hours after surgery

Measure method:

clinical observation

指标中文名:

麻醉复苏质量

指标类型:

次要指标

Outcome:

Quality of Anesthetic Recovery

Type:

Secondary indicator

测量时间点:

麻醉恢复期

测量方法:

观察并记录患者麻醉苏醒时间、拔管时间及PACU期间PONV、补救镇痛、烦躁等不良反应发生情况

Measure time point of outcome:

anesthesia recovery period

Measure method:

Observe and document the postoperative anesthesia recovery time, extubation time, and the occurrence of adverse reactions in the PACU, including PONV, rescue analgesia, and agitation.

指标中文名:

术后住院时间

指标类型:

次要指标

Outcome:

hospitalization time after surgery

Type:

Secondary indicator

测量时间点:

术后

测量方法:

电子病历系统

Measure time point of outcome:

after surgery

Measure method:

Electronic Medical Record System

指标中文名:

疼痛评分

指标类型:

次要指标

Outcome:

Pain Intensity Score

Type:

Secondary indicator

测量时间点:

术后即刻(0h)、术后1、2、6 、24、48h

测量方法:

视觉模拟量表(VAS)

Measure time point of outcome:

Immediate post-operation (0h), post-operation 1h, post-operation 2h, post-operation 6h, post-operation 24h

Measure method:

The visual analog scale,VAS

指标中文名:

术后首次排气及排便时间

指标类型:

次要指标

Outcome:

The first time of flatus and bowel movement after surgery

Type:

Secondary indicator

测量时间点:

术后48小时内

测量方法:

临床观察

Measure time point of outcome:

within 48 hours after surgery

Measure method:

clinical observation

指标中文名:

术后镇痛药物使用量

指标类型:

次要指标

Outcome:

consumption of postoperative analgesic

Type:

Secondary indicator

测量时间点:

术后

测量方法:

电子病历系统

Measure time point of outcome:

after surgery

Measure method:

Electronic Medical Record System

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由第一研究者用电脑随机数表法随机分为两组:C组(对照组)、D组(颊针组),分配比例1:1。

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

The participants will be randomly assigned into two groups by the first investigator using a computer-generated random number table method: Group C (control group) and Group D (buccal acupuncture treatment group), with an allocation ratio of 1:1.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

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:

病例记录表和电子病历系统

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

CRF and Electronic Medical Record System

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above