Evaluation of lignocaine infusion for management of pain after supratentorial craniotomy
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS).
研究概览
简要总结
Pain after craniotomy remains a problem despite the availability of many drugs like opioids, non-steroidal anti-inflammatory drugs (NSAIDS). This is mainly due to concern of adverse effects associated with their use. Lignocaine infusion has shown beneficial effects for management of post operative pain. However, its role in pain following craniotomy is not clear. A prospective, double blind, randomized, placebo controlled study will be conducted on sixty patients undergoing supratentorial craniotomy. Group A patients will be administrated IV bolus of lignocaine in a dose of 1.5mg/kg over 5 minutes starting 10 minutes before induction of anaesthesia followed by a continuous infusion of 2mg/kg/hr which will be continued till the end of surgery and stopped just after tracheal extubation. Whereas, group B will be administrated IV normal saline in a similar dose and duration. Patients will be monitored post operatively for pain in terms of numerical rating scale (NRS) and HR, NIBP, SPO2, RR. We aimed to study the analgesic efficacy and adverse effects of IV lignocaine infusion in patients undergoing supratentorial craniotomy. The primary outcome will be analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS).
and secondary outcome will be total opioid consumption in 24 hours and adverse effects, if any.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and femalae patients undergoing supratentorial craniotomy under General Anesthesia, American Society of Anaesthesiologist(ASA) Class 1 and 2, Glasgow Coma Scale of 15.
排除标准
- •Patients having cardiac conduction abnormalities like atrio-ventricular block.
- •Patients with respiratory, hepatic or renal disease.
- •Patients on treatment with calcium channel blockers or beta-blockers.
- •Patients with altered sensorium.
- •Patients with a history of myopathy or substance abuse.
- •Patients who will be kept mechanically ventilated postoperatively.
- •Allergic to study drug.
- •Patient’s refusal.
结局指标
主要结局
Analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS).
时间窗: Analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS)measured after shifting the patients to post anaesthesia care unit at 0 hour, 1 hour, 2 hour and 3 hour.
次要结局
- 1.Total opioid consumption in 24 hours from start of surgery(2.To observe for adverse effects, if any during surgery & within 24 hours of surgery)
研究者
Dr Sandeep Kundra
Dayanand Medical College and Hospital