Comparing intertransverse process (ITP) block with thoracic paravertebral (TPV) block for postoperative analgesia in patient undergoing modified radical mastectomy (MRM); A randomized controlled non inferiority trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is a double blinded prospective randomized controlled trial comparing the effectiveness of pre operative administration after induction of intertransverse process(ITP) block with thoracic paravertebral(TPV) block on post operative pain relief after modified radical mastectomy(MRM) and will bw carried out in the Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi.The primary outcome will measure the extent of pain. The intensity of pain variable will be recorded using Numerical rating scale(NRS), ranging from 0(no pain) to 10(maximum pain). Each patient will be asked to rate the perceived pain at 30minutes,1,2,6,12,24 and 48 hours post operatively. The secondary outcomes will observe the time needed for first dose of rescue analgesia( IV Tramadol) and total number of dose of rescue analgesia (Tramadol 2mg/kg IV)required for adequate analgesia, intra operative hemodynamic parameters, intra operative fentanyl consumption and time taken to perform the block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.ASA 1 and ASA 2 patients 2.Patient undergoing MRM under General Anaesthesia 3.Patient between 18 to 65 years of age 4.Patient who can understand and provide a valid consent for the procedure and can understand and are willing to report the pain using NRS score.
排除标准
- •1.Patients not giving consent 2.Patient with allergies to Local anaesthetics 3.Patient having bleeding disorders 4.Patient on anticoagulant or antiplatelet drus 5.Localised infections 6.Patient in whom the sonoanatomy of the anaesthetiic injection site is clearly not delineable due to any reason 7.Patient with previous history of breast surgery 8.Patient on long term opioid therapy 9.Patient with peripheral neuropathy 10.INR more than 1.5.
研究者
Dr Piyush Meena
Institute of Medical Sciences BHU