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临床试验/CTRI/2024/08/072663
CTRI/2024/08/072663
尚未招募
4 期

Effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response in patients undergoing Modified radical mastectomy under general anaesthesia

Maulana Azad Medical College and Associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月30日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Maulana Azad Medical College and Associated Lok Nayak Hospital
入组人数
50
试验地点
1
主要终点
1. Serum IL-6 concentration in both the groups

概览

简要总结

We are comparing the effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response in patients undergoing modified radical mastectomy under general anaesthesia. The primary objective of the study is to compare the effect of Serratus Anterior plane block and Erector spinae plane block on serum IL-6 and IL-10 levels in patients undergoing Modified Radical Mastectomy under general anaesthesia, taking a sample size of 50 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 75.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade 1, 2, 3 patients.

排除标准

  • Bleeding diathesis
  • Local skin infection at the site of block
  • Allergy to local anaesthetics or adjuvants.

结局指标

主要结局

1. Serum IL-6 concentration in both the groups

时间窗: Baseline and 24 hours post-operatively

2. Serum IL-10 concentration in both the groups

时间窗: Baseline and 24 hours post-operatively

次要结局

  • Serum cortisol concentrations in both the groups(Baseline and 24hrs postoperatively)
  • Total consumption of intravenous Fentanyl in both the groups(During the duration of the surgery)
  • Time at which the first rescue analgesia is requested by the patient postoperatively as assessed by the NRS pain score in both the groups(2hrs, 6hrs, 12 hrs and 24hrs postoperatively)
  • Total amount of opioid consumption within 24 hours postoperatively in both the groups(24 hrs postoperatively)

研究者

发起方
Maulana Azad Medical College and Associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sandeep J

Maulana Azad Medical College

研究点 (1)

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