Intravenous Lignocaine as an Analgesic Adjunct in Adolescent Idiopathic Scoliosis Surgery (IGNITE-AIS Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- To evaluate postoperative morphine consumption at 24 hours
研究概览
简要总结
This is a single-center study comparing the effect of intravenous (IV) Lignocaine given throughout posterior spinal fusion surgery on the reduction of morphine usage during postoperative period in adolescent idiopathic scoliosis (AIS) patients.
详细描述
Study Rationale
Posterior spinal fusion (PSF) performed for the correction of adolescent idiopathic scoliosis (AIS) is a complex surgery which result in severe postoperative pain. Early and adequate analgesia facilitates early mobilization hence reduces postoperative complications. Multimodal analgesia technique has been shown to improve perioperative pain management and significantly reduced the opioid usage and its side effects. Intravenous lignocaine infusion has been used as an analgesic adjunct for the management of acute postoperative pain in many clinical settings which include adult complex spinal surgery. However, until this date no study which examines AIS patients undergoing PSF surgeries.
Study Design
This is a prospective, double-blinded, randomized placebo-controlled trial. Participants will be randomized using a sequentially numbered, opaque sealed envelope (SNOSE) method into two groups: Group A, Lignocaine and Group B, placebo. Group A will receive 1.5mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion rate will be halved to 1mg/kg/hour until the end of surgery. The same rate will be infused in the recovery room for another half an hour before patient discharge. Group B will receive saline of similar volume and rate as for Group A.
Study Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The medications will be prepared before induction by a nurse or doctor who is neither a member of the trial team and later handed to the anaesthetist in charge of the administration according to the trial protocol. The trial drugs are prepared in a 10-ml syringe for the bolus injection and a 50-ml syringe for continuous infusion. For the bolus injection, IV lignocaine 1% will be drawn into the 10-ml syringe will lignocaine 1% solution according to the weight of the patient (0.15ml/kg) or an equal amount of 0.9% saline. The 50-ml syringe contained either 50ml of lignocaine 1% solution or 0.9% normal saline solution.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) physical status I and II
排除标准
- •Hypersensitivity to amide local anaesthetics/lignocaine
- •Liver disease (alanine aminotransferase, ALT or aspartate aminotransferase, AST more than twice normal)
- •Renal impairment (defined as estimated Glomerular Filtration Rate <= 60ml/min)
- •History of cardiac disease/cardiac arrhythmia
- •Intellectual disability
- •Preoperative chronic pain with regular opioid usage
研究组 & 干预措施
Lignocaine
This arm will receive intravenous Lignocaine bolus and infusion
干预措施: Lignocaine (Drug)
Placebo
This arm will receive Normal saline 0.9% bolus and infusion
干预措施: Normal saline (Drug)
结局指标
主要结局
To evaluate postoperative morphine consumption at 24 hours
时间窗: Immediately post-operation until 24 hours post-operation
Amount of patient controlled analgesia (PCA) morphine usage in mg over 24 hours
次要结局
- To determine the safe dose of intravenous infusion (IVI) lignocaine by measuring the plasma concentration levels(30 minutes, 2 hours, 4 hours and 8 hours after the bolus dose of trial drug)
- To evaluate the effect on propofol dose requirement as measured by processed electroencephalogram (EEG) qCON index(From the start of anaesthesia until the end of surgery (Throughout the surgery which may range from 2 to 5 hours)))