A comparative evaluation of analgesic efficacy of nalbuphine and magnesium sulphate as an adjuvant to ropivacaine in paediatric caudal block
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate analgesic efficacy of ropivacaine with nalbuphine in paediatric caudal block
研究概览
简要总结
INTRODUCTION: Caudal epidural blockade in children is one of the most widely administered techniques of regional anaesthesia. Ropivacaine is a long acting amide local anaesthetic, acts via reversible inhibition of sodium ions influx in nerve fibers and produce effects similar to other local anaesthetics. Adding Nalbuphine to epidural analgesic agents, provides an increase in the efficacy and the duration of postoperative analgesia. Combined epidural magnesium sulfate administration significantly reduces postoperative analgesic requirements.
Aims and Objectives – To evaluate analgesic efficacy of nalbuphine and magnesium sulphate as an adjuvant to ropivacaine in paediatric caudal block.
Materials and Methods- The study will be conducted in department of Anaesthesiology, GGSMCH, Faridkot.
Inclusion Criteria – Age group 1-10yrs, ASA (American Society of Anaesthesiologists) grade I &II.
Patients will be divided in 3 study groups of 30 patients each. Group A: Will receive 1ml/kg of 0.2% Ropivacaine and 1ml normal saline.
Group B: Will receive 1ml/kg of 0.2% Ropivacaine with 0.1 mg/kg Nalbuphine in 1ml normal saline.
Group C: Will receive 1ml/kg of 0.2% Ropivacaine with 50 mg Magnesium sulphate in 1ml normal saline.
Surgery will be done under general anaesthesia .
Duration of postoperative analgesia and total analgesia postoperatively in first 24hrs will be noted and compared.
After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods. P value < 0.05 will be taken as significant and < 0.001 will be taken as highly significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Paediatric participants aged between 1-10 years.
- •American Society of Anaesthesiologists grade I and II patients.
- •Patients undergoing infraumbilical surgeries.
排除标准
- •History of developmental delay or mental retardation, which could make observational pain intensity assessment difficult.
- •Children with known allergy to any of the study drugs.
- •Children with coagulation disorders.
- •Childrenwith coexisting medical illness.
- •Pre-existing neurological diseases.
- •Anatomical abnormalities of spine and sacrum.
- •Any signs of infection at the site of the proposed caudal block.
结局指标
主要结局
To evaluate analgesic efficacy of ropivacaine with nalbuphine in paediatric caudal block
时间窗: Duration of analgesia will be assessed. | Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.
To evaluate analgesic efficacy of ropivacaine with magnesium sulphate in paediatric caudal block
时间窗: Duration of analgesia will be assessed. | Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.
To evaluate analgesic efficacy of ropivacaine alone in paediatric caudal block
时间窗: Duration of analgesia will be assessed. | Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.
To compare analgesic efficacy of ropivacaine alone ,with nalbuphine and with magnesium sulphate in paediatric caudal block
时间窗: Duration of analgesia will be assessed. | Pain intensity will be assessed at end of operation every 2hrly ,4hrly and 8hrly using FLACC Pain scale.
次要结局
- Monitoring of hemodynamic parameters ( HR,Oxygen saturation ,Temperature) intraoperatively and postoperatively.(Perioperative adverse effects will be recorded.)