【ChiCTR2500106079】Optimizing Pain Relief in ERACS: A Comparative Study of Ketamine and Dexamethasone in TAP Block

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基本信息

登记号

ChiCTR2500106079

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2025-07-17

临床申请受理号

靶点

适应症

Healthy Subject Underwent Caesarian Section Surgery

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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.

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试验类型

随机平行对照

试验分期

其它

随机化

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.

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

试验项目经费来源

Personal

试验范围

目标入组人数

实际入组人数

第一例入组时间

2024-11-18

试验终止时间

2025-02-28

是否属于一致性

入选标准

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.；

排除标准

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

研究者信息

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试验机构

Department of Anesthesiology and Intensive Care Diponegoro University

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