A comparative study of ultrasound guided erector spinae plane block with conventional general anesthesia for postoperative analgesia in modified radical mastectomy: A prospective randomised controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the duration of post operative analgesia between two groups.
研究概览
简要总结
Our aim of study is to evaluate efficacy of Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy , to compare duration of post operative analgesia between two groups, to monitor hemodynamic changes, to observe requirement of analgesic consumption and complications.
80 adult female patients of Age 18-65 years of ASA II , III scheduled for Modified Radical Mastectomy will be randomised into 2 groups. Group GE (General anaesthesia + Erector Spinae Plane block) will be receiving 20 ml of 0.5% Levobupivacaine by Ultrasound Guided Erector Spinae Plane Block at T4 unilaterally in sitting position preinduction followed by general anaesthesia. Group G (General anaesthesia) will be induced by conventional general anaesthesia (Fentanyl 2mcg/kg, Propofol 2mg/kg, Vecuronium 0.1mg/kg). Hemodynamics (HR, SBP, DBP, SPO2, EtCO2) will be noted during baseline, after block and at every 20 minutes till the surgery gets completed. Fentanyl Citrate will be supplemented if there will be 20% increase in hemodynamics from baseline. Duration of post operative analgesia in 24hours , VAS score and No. of rescue analgesia will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA – II and III Patient posted for elective Modified Radical Mastectomy.
- •Patient able to give verbal and informed consent.
- •Patient able to understand VAS regarding assessment of pain.
排除标准
- •Patient refusal Allergy to local anaesthetics.
- •Patient with local site infection Pregnant and lactating females Patient who are unable to give consent Patient with coagulopathy disorder Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure., etc Patient with cardiac, renal, respiratory, neurological conditions.
结局指标
主要结局
To compare the duration of post operative analgesia between two groups.
时间窗: baseline, after block, after GA, 2min, 5min,10min, 20min, 30min, 60min, 90min, 120min
次要结局
- Hemodynamic stability(Post operative requirement of rescue analgesia if VAS more than 4)