Comparison of analgesic efficacy between ultrasound guided erector spinae plane block and paravertebral block for postoperative pain in modified radical mastectomy for breast carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare post-operative VAS score between ESP block versus thoracic paravertebral block.
研究概览
简要总结
Prospective, randomized single blinded study.
After obtaining the institutional ethical committee approval and written informed consent from the participants, they will be enrolled into our study.
A total of 60 participants will be enrolled and randomized into two equal groups of 30 each.
Group ESP: Ultrasound guided ESP block with 30ml of Inj. Ropivacaine 0.375%
Group PVB: Ultrasound guided Thoracic PVB with 30ml of Inj. Ropivacaine 0.375%
· Hemodynamic parameters will be monitored at different time point such as baseline, after induction, after block and after every 15 minute interval.
ü Systolic blood pressure
ü Diastolic blood pressure
ü Heart rate
ü Mean arterial pressure
· Duration of surgery.
· Total intraoperative inj. fentanyl consumption.
· VAS score will be monitored at 0min, 15 minutes, 30 minutes 1 hour, 2 hours, 6hour, 12 hour, 24 hours post-operatively.
· Time for requirement of first rescue analgesia will be noted.
· Total rescue analgesia in 24 hours will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 56.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 18- 56 years.
- •Patient diagnosed as the case of breast cancer.
- •American society of Anaesthesiologists grade I and II patients.
排除标准
- •Patient with known coagulopathy.
- •Patients allergic to the study drug.
- •Patients with hepatic or renal dysfunction.
- •Patients with history of receiving anticoagulant treatment.
- •Patients having history of chronic opioid consumption.
结局指标
主要结局
To compare post-operative VAS score between ESP block versus thoracic paravertebral block.
时间窗: VAS score will be measured at baseline. Block will be given after induction. VAS score will be measured after induction at 5 mins, 10 mins, 15 mins, 30 mins, 60 mins, 90 mins, 120 mins
次要结局
- 1. To compare intraoperative hemodynamic stability between ESP versus thoracic paravertebral block.(2. To observe the time needed for first rescue analgesia.)
研究者
Ravi Kumar Meena
Institute of Medical Sciences, Banaras Hindu University