A randomized, double blind, superiority trial comparing hyperbaric bupivacaine and hyperbaric ropivacaine in neonates and infants undergoing infraumbilical surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be assessing the effectiveness of the anaesthesic drug by comparing the block parameters such as onset, duration
研究概览
简要总结
Spinal anesthesia, also called subarachnoid block, is increasingly used for infraumbilical surgeries in infants and children. The spinal cord in infants ends lower than in adults, making specific techniques necessary to avoid injury. This method provides advantages such as reduced incidence of hypotension, hypoxia, bradycardia, and postoperative apnea, compared to general anesthesia (GA), which enhances cardiovascular and respiratory stability. After surgery, early mobilization, hydration, and proper pain management are essential.
Hyperbaric bupivacaine and ropivacaine, amide local anesthetics, are commonly used in spinal anesthesia. Bupivacaine is highly potent but associated with higher risks of hypotension and bradycardia, while ropivacaine has a lower cardiotoxicity and is favored for sensory-motor differential blockade. Both anesthetics are effective, though bupivacaine offers faster and denser blocks, while ropivacaine allows earlier ambulation and recovery.
This study aims to compare the efficacy of 0.5% hyperbaric bupivacaine versus 0.5% hyperbaric ropivacaine in infants undergoing infraumbilical surgeries. Primary objectives include comparing neuronal blockade (motor and sensory), while secondary objectives include assessing hemodynamic stability, post-operative apnea, analgesia needs, and surgeon satisfaction.
A double-blind randomized controlled trial will be conducted at AIIMS Nagpur. Patients under 1 year of age undergoing infraumbilical surgeries will be included, with those meeting exclusion criteria such as neurological abnormalities or surgery duration over 90 minutes being excluded. Each group will receive either hyperbaric bupivacaine or ropivacaine, and various anesthetic parameters will be monitored, including onset time, duration of blockade, and postoperative complications. Data analysis will involve statistical methods such as the independent T-test and chi-square test for comparison.
This research aims to assess the safety and efficacy of these anesthetics, contributing to better understanding and decision-making for pediatric spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Parents willing to enroll their children in this study.
- •Age less than or equal to 1 year.
- •Patients undergoing infraumbilical surgeries.
- •ASA grade 1 & 2.
排除标准
- •Parents not consenting for the procedure.
- •Patients having increased intracranial pressure.
- •Patients having allergy to local anesthetic drugs.
- •Patients having local site infection.
- •Uncorrected hypovolaemia.
- •Coagulation abnormalities.
- •Neurological abnormalities such as spina bifida, meningocele.
- •Patients already on mechanical ventilation.
结局指标
主要结局
The primary outcome will be assessing the effectiveness of the anaesthesic drug by comparing the block parameters such as onset, duration
时间窗: 1,5,10,15,20,30,45,60,90 mins
次要结局
- Heamodynamic stability: assessing the heart rate , blood pressure, oxygen saturation throughout the procedure.(Requirement of rescue analgesia and conversion to GA or mechanical ventilation.)