A randomised clinical trial to compare the efficacy of opioid free anaesthesia with retrolaminar block and conventional anaesthesia method to know enhanced recovery in posterior lumbosacral surgeries
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- To assess postoperative pain intensity at rest and during movement and to assess time from isoflurane discontinuation to tracheal extubation and recovery time
研究概览
简要总结
General physical examination and routine blood investigations will be conducted preoperatively. In the operating theatre standard monitors will be connected. Anaesthesia will be induced using Propofol and Dexmeditomidine fpr both groups. Endotracheal intubation will be facilitated using iv Atracurium. Maintenance of anaesthesia will be using Isoflurane with atracurium. Additional Fentanyl will be given to conventional anaesthesia group. Before skin incision, both groups receive Inj. Paracetamol. After skin incision, Retrolaminar block with opioid free anaesthesia group will be given Retrolaminar block with 0.25% Bupivacaine, Dexamethasone and MgSO4.At the conclusion of surgery, isoflurane will be discontinued and residual neuromuscular blockage reversed using iv neostigmine and glycopyrrolate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I or II, with BMI between 25 and 30kg/m2, undergoing elective lumbosacral spine surgeries under general anaesthesia.
排除标准
- •Patients with known allergies to medications used in this study, patients undergoing long term pain management, patients with preexisting respiratory, renal, hepatic or cardiovascular conditions, patients with clotting disorders or coagulopathies.
结局指标
主要结局
To assess postoperative pain intensity at rest and during movement and to assess time from isoflurane discontinuation to tracheal extubation and recovery time
时间窗: 30 minutes, 2 hours, 4 hours, 8 hours,12 hours and 24 hours
次要结局
- Secondary outcomes of the trial are - to measure time for first request of rescue analgesic (ketorolac) after surgery, to calculate total ketorolac consumption within first 24 hours postoperatively, to assess time of discharge from PACU (Post anaesthesia care unit), to evaluate incidence of postoperative side effects particularly nausea, vomiting & sedation during firt 24 hours postoperatively & to evaluate & compare the levels of inflammatory marker(C Reactive protein-CRP) in pre & postoperative periods(24 hours postoperatively)
研究者
Dr Arya Srinivasan
Shri B. M. Patil medical college, hospital and research center