Effects of General Anesthesia vs. General Anesthesia and Paravertebral Block to IL-2, IL-6, PGE2, MMP-9, and Clinical Outcome in Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Concentration of IL-2 in blood serum
研究概览
简要总结
Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
- •Balinese race
- •ASA physical status I, II, III
排除标准
- •History of allergy to drugs used in anesthesia
- •History psychiatric disorder
- •History of perioperative transfusion
- •History of autoimmune disease
- •History of taking beta blockers or anti-platelet aggregation medications
- •Previous breast surgery
- •Spine deformity
- •Coagulopathy
- •Local infections in paravertebral block site
- •Decreased renal function
- •Neurological deficits
- •Peptic ulcer
结局指标
主要结局
Concentration of IL-2 in blood serum
时间窗: 24-hours after surgery
Concentration of IL-2 level in blood serum
Visual Analog Scale (VAS)
时间窗: 24-hours after surgery
pain score measured by visual analog scale (VAS), scaled between 0 (no pain) and 10 (worst pain)
Concentration of IL-6 in blood serum
时间窗: 24-hours after surgery
Concentration of IL-6 level in blood serum
次要结局
- Concentration of MMP-9 level in blood serum(24-hours after surgery)
- Concentration of PGE2 level in blood serum(24-hours after surgery)
研究者
Christopher Ryalino
Lecturer
Udayana University