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General Anesthesia vs General Anesthesia+PECS Block on Inflammation in Breast Cancer
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注册号：

Registration number：

 ChiCTR2500108413 

最近更新日期：

Date of Last Refreshed on：

 2025-08-29 14:53:51 

注册时间：

Date of Registration：

 2025-08-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

General Anesthesia vs General Anesthesia+PECS Block on Inflammation in Breast Cancer

Public title：

General Anesthesia vs General Anesthesia+PECS Block on Inflammation in Breast Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Comparison of the Effects of General Anesthesia and a Combination of General Anesthesia with PECS Block on the Level of Inflammation in Breast Cancer Surgery – A Biomarker Study on IL‑1β and NLR

Scientific title：

Comparison of the Effects of General Anesthesia and a Combination of General Anesthesia with PECS Block on the Level of Inflammation in Breast Cancer Surgery – A Biomarker Study on IL‑1β and NLR

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：

Yan Wisnu Prajoko 

研究负责人：

Yan Wisnu Prajoko 

Applicant：

Yan Wisnu Prajoko 

Study leader：

Yan Wisnu Prajoko 

申请注册联系人电话：

Applicant telephone：

 +62 812 2904 279

研究负责人电话：

Study leader's
telephone：

+62 812 2904 279

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

 +62 812 2904 279

申请注册联系人电子邮件：

Applicant E-mail：

 yanprajoko1975@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 yanprajoko1975@gmail.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：

Jl. Letjen. S. Parman No. 2A Gajahmungkur – Semarang

研究负责人通讯地址：

Jl. Letjen. S. Parman No. 2A Gajahmungkur – Semarang

Applicant address：

Jl. Letjen. S. Parman No. 2A Gajahmungkur – Semarang

Study leader's address：

Jl. Letjen. S. Parman No. 2A Gajahmungkur – Semarang

申请注册联系人邮政编码：

Applicant postcode：

 50231

研究负责人邮政编码：

Study leader's postcode：

 50231

申请人所在单位：

KSM Bedah Onkologi RSUP Dr. Kariadi

Applicant's institution：

KSM Bedah Onkologi RSUP Dr. Kariadi

研究负责人所在单位：

KSM Bedah Onkologi RSUP Dr. Kariadi

Affiliation of the Leader：

KSM Bedah Onkologi RSUP Dr. Kariadi

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：

 1571/EC/KEPK-RSDK/2023

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：

Komisi Etik Penelitian Kesehatan RSUP Dr. Kariadi

Name of the ethic committee：

Komisi Etik Penelitian Kesehatan RSUP Dr. Kariadi

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-10 00:00:00

伦理委员会联系人：

Dr. dr. Moh. Sofyan Harahap, Sp.An-TI, Subsp.N.An(K

Contact Name of the ethic committee：

Dr. dr. Moh. Sofyan Harahap, Sp.An-TI, Subsp.N.An(K

伦理委员会联系地址：

Jl. Dr. Sutomo No. 16 Semarang

Contact Address of the ethic committee：

Jl. Dr. Sutomo No. 16 Semarang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +62 24 8413476

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 kepk.rskariadi@gmail.com

研究实施负责（组长）单位：

Department of Anesthesiology and Intensive Care Diponegoro University

Primary sponsor：

Department of Anesthesiology and Intensive Care Diponegoro University

研究实施负责（组长）单位地址：

Jl. Prof. Soedarto, Tembalang, Semarang

Primary sponsor's address：

Jl. Prof. Soedarto, Tembalang, Semarang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Indonesia

省(直辖市)：

Central Java

市(区县)：

Semarang

Country：

Indonesia

Province：

Central Java

City：

Semarang

单位(医院)：

RSUP Dr. Kariadi

具体地址：

Jl. Dr. Sutomo No.16, Semarang

Institution
hospital：

RSUP Dr. Kariadi

Address：

Jl. Dr. Sutomo No.16, Semarang

经费或物资来源：

Dana Hibah 2023

Source(s) of funding：

Dana Hibah 2023

研究疾病：

Breast Cancer  

Target disease：

Breast Cancer

研究疾病代码：

C50

Target disease code：

C50

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：

To compare postoperative IL‑1β levels and NLR in breast cancer surgery patients who received general anesthesia alone versus those who received general anesthesia combined with PECS II block  

Objectives of Study：

To compare postoperative IL‑1β levels and NLR in breast cancer surgery patients who received general anesthesia alone versus those who received general anesthesia combined with PECS II block

药物成份或治疗方案详述：

1. General anesthesia (GA) alone 2. GA combined with PECS II block (30 cc of 0.25% bupivacaine administered before incision). IL-1β and NLR levels were measured preoperatively and 24 hours postoperatively. 

Description for medicine or protocol of treatment in detail：

1. General anesthesia (GA) alone 2. GA combined with PECS II block (30 cc of 0.25% bupivacaine administered before incision). IL-1β and NLR levels were measured preoperatively and 24 hours postoperatively. 

纳入标准：

Inclusion criteria

排除标准：

Patients who decline to participate in the study

Exclusion criteria：

Patients who decline to participate in the study

研究实施时间：

Study execute time：

从 From 2023-10-10 00:00:00至 To 2024-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-01 00:00:00 至 To 2024-01-31 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 24

Group：

Group 1

Sample size：

干预措施：

Standard general anesthesia

干预措施代码：

Intervention：

Standard general anesthesia

Intervention code：

组别：

Group 2

样本量：

 24

Group：

Group 2

Sample size：

干预措施：

General anesthesia plus PECS II block using 0.25% bupivacaine, 30mL

干预措施代码：

Intervention：

General anesthesia plus PECS II block using 0.25% bupivacaine, 30mL

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Indonesia

省(直辖市)：

 Central Java 

市(区县)：

 Semarang 

Country：

Indonesia

Province：

Central Java

City：

Semarang

单位(医院)：

 Dr. Kariadi General Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Dr. Kariadi General Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Postoperative IL-1β level (pg/mL)

指标类型：

主要指标

Outcome：

Postoperative IL-1β level (pg/mL)

Type：

Primary indicator

测量时间点：

24 hours

测量方法：

Measure time point of outcome：

24 hours

Measure method：

指标中文名：

Preoperative IL-1β level (pg/mL

指标类型：

次要指标

Outcome：

Preoperative IL-1β level (pg/mL

Type：

Secondary indicator

测量时间点：

Baseline

测量方法：

Measure time point of outcome：

Baseline

Measure method：

指标中文名：

Change (Δ) in IL-1β level (pg/mL)

指标类型：

次要指标

Outcome：

Change (Δ) in IL-1β level (pg/mL)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Preoperative Neutrophil-to-Lymphocyte Ratio (NLR)

指标类型：

次要指标

Outcome：

Preoperative Neutrophil-to-Lymphocyte Ratio (NLR)

Type：

Secondary indicator

测量时间点：

Baseline

测量方法：

Measure time point of outcome：

Baseline

Measure method：

指标中文名：

Postoperative Neutrophil-to-Lymphocyte Ratio (NLR)

指标类型：

次要指标

Outcome：

Postoperative Neutrophil-to-Lymphocyte Ratio (NLR)

Type：

Secondary indicator

测量时间点：

24 hours

测量方法：

Measure time point of outcome：

24 hours

Measure method：

指标中文名：

Change (Δ) in Neutrophil-to-Lymphocyte Ratio (NLR)

指标类型：

次要指标

Outcome：

Change (Δ) in Neutrophil-to-Lymphocyte Ratio (NLR)

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：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 59 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）：

Participants will be randomized using a centralized, computer-generated sequence via an online randomization tool. Randomization will be performed only after eligibility has been confirmed.

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

Participants will be randomized using a centralized, computer-generated sequence via an online randomization tool. Randomization will be performed only after eligibility has been confirmed.

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：

Participants: Blinded to group allocation. Outcome assessors/observers: Blinded to group allocation. Researchers: Not blinded.

Blinding：

Participants: Blinded to group allocation. Outcome assessors/observers: Blinded to group allocation. Researchers: Not blinded.

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）：

All raw data generated during the course of this study will be made publicly available no later than six months after the trial concludes. The data will be anonymized to protect participant confidentiality and will be shared through a recognized public data repository.

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

All raw data generated during the course of this study will be made publicly available no later than six months after the trial concludes. The data will be anonymized to protect participant confidentiality and will be shared through a recognized public data repository.

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：

All study data will be collected using standard forms by trained staff. Source documents like medical records will be safely stored and linked to the study data using participant codes. Data will be entered into a secure database and checked regularly to make sure it’s accurate. Any mistakes will be corrected by comparing with the original records. Access to the data will be limited to authorized team members to keep it safe.

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

All study data will be collected using standard forms by trained staff. Source documents like medical records will be safely stored and linked to the study data using participant codes. Data will be entered into a secure database and checked regularly to make sure it’s accurate. Any mistakes will be corrected by comparing with the original records. Access to the data will be limited to authorized team members to keep it safe.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-08-29 14:53:35
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