Comparison of two different doses of intrathecal buprenorphine with 0.75% hyperbaric ropivacaine in elective caesarean section for post operative analgesia. A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To assess the onset and duration of motor and sensory blockade and to evaluate the pain intensity using VAS score
研究概览
简要总结
Pre anaesthetic evaluation will be done bedside and all routine investigations noted. Patient will be kept nil per oral for 8 hours. Patients will be positioned and spinal anaesthesia will be carried out by anaesthesiologist under strict aaeptic precautions. After explaining the procedure informed written consent will be obtained. Group 1 will receive 30mcg of of buprenorphine with 0.75% hyperbaric ropivacaine while group 2 will receive 60mcg of buprenorphine with 0.75% hyperbaric ropivacaine. Vitals will be monitored throughout the procedure and post operatively. Time for onset and duration of motor and sensory blockade, time to first request for analgesia, VAS score at 1, 2, 4, 6, 12, 24 hours, numer of rescue analgesics in first 24 hours, incidence of adverse events and APGAR score of the newborn will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women of 18 to 40 years scheduled for elective caesarean section.
排除标准
- •Contraindications to spinal anaesthesia, opioid allergy, pregnancy related complications like preeclampsia, known systemic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, severe hepatic and renal diseases.
结局指标
主要结局
To assess the onset and duration of motor and sensory blockade and to evaluate the pain intensity using VAS score
时间窗: To check pain intensity post surgery at 1, 2, 4, 6, 12, 24 hours
次要结局
未报告次要终点
研究者
Dr Harish T
Shri B. M. Patil Medical College Hospital and Research Centre