A comparative study between hyperbaric ropivacaine and hyperbaric bupivacaine for spinal anaesthesia in infra-umbilical surgeries in a tertiary care centre in Manipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Duration of sensory and motor block following spinal anesthesia with hyperbaric bupivacaine versus ropivacaine.
研究概览
简要总结
Spinal anesthesia is widely used for infra-umbilical surgeries due to its rapid onset and reliable effect. Hyperbaric bupivacaine is the standard agent but is associated with prolonged motor block and potential hemodynamic instability. Hyperbaric ropivacaine, being a pure S-enantiomer, offers comparable sensory block with faster motor recovery and greater cardiovascular safety. However, limited data exist in the Indian population. This trial aims to compare hyperbaric bupivacaine and hyperbaric ropivacaine with respect to sensory and motor block characteristics, duration of analgesia, hemodynamic stability, and adverse effects in adult patients undergoing infra-umbilical surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 65 years ASA (American Society of Anesthesiologists) physical status I or II Scheduled for elective infraumbilical surgeries (e.g., inguinal hernia repair, hydrocelectomy, gynecological procedures, lower limb orthopedic surgeries) Patients who provide written informed consent.
排除标准
- •Known hypersensitivity to local anesthetics of the amide group History of coagulopathy or on anticoagulant therapy Local infection at the puncture site History of spinal deformities, previous spinal surgery, or neurological disorders Pregnant or lactating women Patients on medications that may interact with local anesthetics Severe cardiovascular, hepatic, or renal disease.
结局指标
主要结局
Duration of sensory and motor block following spinal anesthesia with hyperbaric bupivacaine versus ropivacaine.
时间窗: Baseline (before spinal block) | At regular intraoperative intervals (every 5 minutes for the first 30 minutes, then every 15 minutes until block regression) | At the time of complete recovery from sensory and motor bloc
次要结局
- Duration of effective analgesia, hemodynamic stability including heart rate & blood pressure, & incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, shivering, & pruritus.(From intrathecal injection to twenty-four hours postoperatively, with hemodynamic parameters assessed every five minutes for the first thirty minutes, every ten minutes until the end of surgery, & in the post-anesthesia care unit; adverse effects assessed intraoperatively & up to twenty-four hours postoperatively.)
研究者
Dr.Thounaojam Dinesh Singh
Shija Hospitals and Research Institute