CTRI/2024/06/068501尚未招募1 期
Effect of Erector Spinae plane block versus Peritumoral Local Anaesthetic infiltration on Post operative immune response in patients undergoing surgery for breast cancer
Maulana Azad Medical College & associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年6月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1)Neutrophil to lymphocyte ratio in both the groups
研究概览
简要总结
we are comparing the effect of ESP block with peritumoral local anaesthetic infiltration on inflammatory and immune response in patients undergoing surgery for breast cancer under General anaesthesia . The primary objective of the study is to compare the effect of ESP block and peritumoral local anaesthetic infiltration on post-operative markers of i nflammation ,immune suppression ,and angiogenesis in patients undergoing modified radical mastectomy , taking a sample size of 34 patients for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age18-65 years 2)ASA physical status I,II&III 3)unilateral breast cancer.
排除标准
- •BMI more than 35kg/m2
- •any structural deformity of thoracic spine
- •known allergy to LA drugs
- •any infection at the site of block or infiltration.
结局指标
主要结局
1)Neutrophil to lymphocyte ratio in both the groups
时间窗: baseline and 24 hours after surgery
2)Platelet to lymphocyte ratio in both the groups.
时间窗: baseline and 24 hours after surgery
次要结局
- Mean difference in serum 1interleukin (IL)-6,IL-8 and vascular endothelial growth factor (VEGF) levels in both the groups at 24 hrs after surgery
- Total consumption of opioids(24 hours after surgery)
- Quality of recovery-15(24 hours after surgery)
- Time to return to intended oncological therapy(3 weeks or 4 weeks after surgery)
研究者
Pathan Arief
Maulana Azad Medical College
研究点 (1)
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