ChiCTR2500106079 版本V1.0 版本创建时间2025/07/17 09:11:11 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：

ChiCTR2500106079 

最近更新日期：

Date of Last Refreshed on：

2025-07-17 09:10:51 

注册时间：

Date of Registration：

2025-07-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Optimizing Pain Relief in ERACS: A Comparative Study of Ketamine and Dexamethasone in TAP Block

Public title：

Optimizing Pain Relief in ERACS: A Comparative Study of Ketamine and Dexamethasone in TAP Block

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Comparison of Ketamine and Dexamethasone as Adjuvant of Transversus Abdominis Plane (TAP) Block in Enhances Recovery After Caesarean Section (ERACS)

Scientific title：

Comparison of Ketamine and Dexamethasone as Adjuvant of Transversus Abdominis Plane (TAP) Block in Enhances Recovery After Caesarean Section (ERACS)

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：

Taufan Pramadika 

研究负责人：

Mirad Aditya 

Applicant：

Taufan Pramadika 

Study leader：

Mirad Aditya 

申请注册联系人电话：

Applicant telephone：

+62 882 3803 4609

研究负责人电话：

Study leader's telephone：

+62 812 8804 5454

申请注册联系人传真 ：

Applicant Fax：

taufanpramadika@gmail.com

研究负责人传真：

Study leader's fax：

mirad.aditya20@gmail.com

申请注册联系人电子邮件：

Applicant E-mail：

taufanpramadika@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

mirad.aditya20@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 Mintojiwo dalam II No 32 Semarang

研究负责人通讯地址：

Kintelan Baru no.68A rt3 RW 2 kelurahan bendungan kecamatan Gajah mungkur Semarang selatan?kota?semarang

Applicant address：

Jl Mintojiwo dalam II No 32 Semarang

Study leader's address：

Kintelan Baru no.68A rt3 RW 2 kelurahan bendungan kecamatan Gajah mungkur Semarang selatan?kota?semarang

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：

Department of Anesthesiology and Intensive Care Diponegoro University

Applicant's institution：

Department of Anesthesiology and Intensive Care Diponegoro University

研究负责人所在单位：

Department of Anesthesiology and Intensive Care Diponegoro University

Affiliation of the Leader：

Department of Anesthesiology and Intensive Care Diponegoro University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

No. 620/EC/KEPK/FK-UNDIP/XI/2024

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 Fakultas Kedokteran Universitas Diponegoro

Name of the ethic committee：

Komisi Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Diponegoro

伦理委员会批准日期：

Date of approved by ethic committee：

2024-11-14 00:00:00

伦理委员会联系人：

Prof. Dr. dr. Banundari Rachmawati, Sp.PK, Subsp. B.D.K.TE.M, Subsp.

Contact Name of the ethic committee：

Prof. Dr. dr. Banundari Rachmawati, Sp.PK, Subsp. B.D.K.TE.M, Subsp.

伦理委员会联系地址：

Jl. Prof Mr. Sunario Kampus Universitas Diponegoro Tembalang, Semarang Kode Pos 50275

Contact Address of the ethic committee：

Jl. Prof Mr. Sunario Kampus Universitas Diponegoro Tembalang, Semarang Kode Pos 50275

伦理委员会联系人电话：

Contact phone of the ethic committee：

+62 881 0387 92408

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：

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 Mintojiwo dalam III No 32 Semarang

Primary sponsor's address：

Jl Mintojiwo dalam III No 32 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)：

Country：

Indonesia

Province：

Central Java

City：

单位(医院)：

Department of Anesthesiology and Intensive Care Diponegoro University

具体地址：

Jl Mintojiwo dalam III No 32 Semarang

Institution
hospital：

Department of Anesthesiology and Intensive Care Diponegoro University

Address：

Jl Mintojiwo dalam III No 32 Semarang

经费或物资来源：

Personal

Source(s) of funding：

Personal

Target disease：

Healthy Subject Underwent Caesarian Section Surgery

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：

This study aims to evaluate and compare the effectiveness of ketamine and dexamethasone as adjuvants in TAP block for ERACS, contributing to improved postoperative outcomes.  

Objectives of Study：

This study aims to evaluate and compare the effectiveness of ketamine and dexamethasone as adjuvants in TAP block for ERACS, contributing to improved postoperative outcomes.

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. Female patients who underwent cesarean section and provided informed consent. 2. Age 25-45; 3. BMI of 18.5–30 kg/m2; 4. ASA physical status I–III; 5. no history of long-term analgesic use ; 6. no history of alcohol consumption; 7. no known allergies to opioids or anesthetic agents.

Inclusion criteria

1. Female patients who underwent cesarean section and provided informed consent. 2. Age 25-45; 3. BMI of 18.5–30 kg/m2; 4. ASA physical status I–III; 5. no history of long-term analgesic use ; 6. no history of alcohol consumption; 7. no known allergies to opioids or anesthetic agents.

排除标准：

1. Patients experiencing shock 2. Patiens experiencing major complications during surgery 3. Patient requiring conversion to general anesthesia

Exclusion criteria：

1. Patients experiencing shock 2. Patiens experiencing major complications during surgery 3. Patient requiring conversion to general anesthesia

研究实施时间：

Study execute time：

从 From 2024-11-18 00:00:00至 To 2025-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-11-19 00:00:00 至 To 2025-01-31 00:00:00  

干预措施：

Interventions：

组别：

Group 1

样本量：

17

Group：

Group 1

Sample size：

干预措施：

Bilateral TAP block 0.25% bupivacaine (20 mL) combined with 20 mg of ketamine per side

干预措施代码：

Intervention：

Bilateral TAP block 0.25% bupivacaine (20 mL) combined with 20 mg of ketamine per side

Intervention code：

组别：

Group 2

样本量：

17

Group：

Group 2

Sample size：

干预措施：

Bilateral TAP block 0.25% bupivacaine (20 mL) combine with 4 mg of dexamethasone per side.

干预措施代码：

Intervention：

Bilateral TAP block 0.25% bupivacaine (20 mL) combine with 4 mg of dexamethasone per side.

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)：

  

Country：

Indonesia 

Province：

Central java 

City：

 

单位(医院)：

Tidar General Regional Hospital 

单位级别：

Primary 

Institution
hospital：

Tidar General Regional Hospital

Level of the institution：

Primary

测量指标：

Outcomes：

指标中文名：

Rescue Analgesia Frequency

指标类型：

主要指标

Outcome：

Rescue Analgesia Frequency

Type：

Primary indicator

测量时间点：

6 hours, 12 hours, 18 hours, 24 hours after surgery

测量方法：

Measure time point of outcome：

6 hours, 12 hours, 18 hours, 24 hours after surgery

Measure method：

指标中文名：

Total opioid dose within 24 hours after surgery

指标类型：

主要指标

Outcome：

Total opioid dose within 24 hours after surgery

Type：

Primary indicator

测量时间点：

6 hours, 12 hours, 18 hours, 24 hours after surgery

测量方法：

Measure time point of outcome：

6 hours, 12 hours, 18 hours, 24 hours after surgery

Measure method：

指标中文名：

Visual Analogue Scale

指标类型：

次要指标

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

测量时间点：

6 hours, 12 hours, 18 hours, 24 hours after surgery

测量方法：

Measure time point of outcome：

6 hours, 12 hours, 18 hours, 24 hours after surgery

Measure method：

指标中文名：

Hypotension

指标类型：

副作用指标

Outcome：

Hypotension

Type：

Adverse events

测量时间点：

24 hours after surgery

测量方法：

Measure time point of outcome：

24 hours after surgery

Measure method：

指标中文名：

Bradycardia

指标类型：

副作用指标

Outcome：

Bradycardia

Type：

Adverse events

测量时间点：

24 hours after surgery

测量方法：

Measure time point of outcome：

24 hours after surgery

Measure method：

指标中文名：

Post Operative Nausea and Vomits (PONV)

指标类型：

副作用指标

Outcome：

Post Operative Nausea and Vomits (PONV)

Type：

Adverse events

测量时间点：

24 hours after surgery

测量方法：

Measure time point of outcome：

24 hours after surgery

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No Sample collected

组织：

Sample Name：

No Sample collected

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 25 岁 years
最大 Max age 45 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）：

The random number sequence used for group allocation in this study was generated by an independent statistician using a computer-based randomization software (e.g., Random.org or a custom script in R or Python). Block randomization with variable block sizes (e.g., blocks of 4 and 6) was employed to ensure balanced distribution of participants between the ketamine and dexamethasone groups throughout the enrollment period. This method minimizes selection bias and maintains group comparability. The randomization sequence was securely stored and concealed from the investigators and clinical staff involved in patient care. Allocation concealment was achieved using sequentially numbered, opaque, sealed envelopes (SNOSE), prepared by a research assistant not involved in the study procedures or outcome assessment. These envelopes were opened only after participant enrollment, ensuring that group assignment remained unknown until the point of intervention, thereby preserving the integrity of the double-blind design.

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

The random number sequence used for group allocation in this study was generated by an independent statistician using a computer-based randomization software (e.g., Random.org or a custom script in R or Python). Block randomization with variable block sizes (e.g., blocks of 4 and 6) was employed to ensure balanced distribution of participants between the ketamine and dexamethasone groups throughout the enrollment period. This method minimizes selection bias and maintains group comparability. The randomization sequence was securely stored and concealed from the investigators and clinical staff involved in patient care. Allocation concealment was achieved using sequentially numbered, opaque, sealed envelopes (SNOSE), prepared by a research assistant not involved in the study procedures or outcome assessment. These envelopes were opened only after participant enrollment, ensuring that group assignment remained unknown until the point of intervention, thereby preserving the integrity of the double-blind design.

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：

To ensure double-blinding, an independent pharmacist prepared identical, coded syringes for administration, and the anesthesiologist performing the procedure was different from the clinical assessors

Blinding：

To ensure double-blinding, an independent pharmacist prepared identical, coded syringes for administration, and the anesthesiologist performing the procedure was different from the clinical assessors

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

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：

  2025-07-17 09:10:51