A Prospective randomized double blinded controlled study based on usefulness of Erector spinae block under ultrasound guidance versus control in patient undergoing PCNL Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Favourable outcome is expected for ultrasound guided ESP Block in comparison to control group.
研究概览
简要总结
A Prospective randomized double blinded controlled study based on usefulness of Erector spinae block under ultrasound guidance versus control in patient undergoing PCNL Surgery for the duration of 1 year in which favourable outcome for ultrasound guided ESP Block in comparison to control group. PCNL is one most popular surgical procedure to remove renal stones through small puncture through the skin. PCNL has evolved remarkably since the eighties when it was first described. The cause of the Postoperative pain in this surgery is due to distention of renal capsule, pelvicalyceal system and nephrostomy tube placed after surgery. Pain due to surgery is both visceral (from kidney and ureter - (T10 to T12)) and somatic pain (T 8 - T 12). Various option such as use of opioids, NSAID and other pain medications are used to decrease the pain but have side effects such as nausea, vomiting, constipation tolerance etc. For this study, there will be two groups to evaluate the efficacy of Erector spinae block with. 25 percent of Bupivacaine (20 ml) 50 mg versus control group Normal saline (20ml) for Postoperative duration of pain, Postoperative analgesic consumption and assess effects on pain score. Aim of the study is to do a comparative study of Postoperative analgesia between ultrasound guided ESP Block and versus control group in PCNL Surgery. The primary objective is assessment of duration of Postoperative analgesia and secondary objective is Total analgesic requirement in 24 hour and Postoperative opioid consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American society of Anesthesiologist I and II 2.Patient with BMI more than 35.
排除标准
- •1.patient with excessive bleeding 2.patients having supracostal puncture.
- •3.significant residual stone more than 1 cm and need for second look.
- •4.solitary kidney 5.dermal infection in the injection site 6.contrast and drug allery 7.Body mass index more than 35 7.Surgery lasting more than 180 minutes.
结局指标
主要结局
Favourable outcome is expected for ultrasound guided ESP Block in comparison to control group.
时间窗: 1 hour, 2 hour, 3 hour, 4 hour,5 hour, 6 hour, 10 hour, 14 hour, 18 hour, 24 hour.
次要结局
- Total analgesic requirement in 24 hour and Postoperative opioid consumption.(1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 10 hour, 14 hour, 18 hour, 24 hour.)
研究者
Dr Anagha Vinod
Sri Narayani Hospital and Research Centrere