Comparison of combination of intrathecal bupivacaine fentanyl with combination of bupivacaine butarphenol for lower limb orthopaedic procedures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Duration of effective analgesia
研究概览
简要总结
This randomized parallel group active controlled clinical trial aims to compare the efficacy and safety of two intrathecal drug combinations bupivacaine fentanyl and bupivacaine butorphanol in patients undergoing lower limb orthopedic surgeries. The primary objective is to evaluate and compare the duration of effective analgesia. Secondary objectives include comparing the onset and duration of sensory and motor block, hemodynamic changes, and incidence of adverse effects. The study hypothesizes that there may be a significant difference in analgesic profile and block characteristics between the two combinations.
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
- •Patients above 18 years of ASA physical status 1 or 2 undergoing lower limb orthopaedic procedures.
排除标准
- •Study drugs contraindicated Patients with neurological disease spinal deformity local skin infection or mental disorder those who were morbidly obese with impaired renal or hepatic function ASA Grade nore than 2 or history of opioid dependence.
结局指标
主要结局
Duration of effective analgesia
时间窗: Duration of effective analgesia | Time from intrathecal injection to first request for rescue analgesia post operatively patient will be monitored every hourly for hours
Time from intrathecal injection to first request for rescue analgesia
时间窗: Duration of effective analgesia | Time from intrathecal injection to first request for rescue analgesia post operatively patient will be monitored every hourly for hours
次要结局
- Onset time of sensory block(At baseline upto 10 minutes after injection)
- Onset time of motor block
- Dermatomal level of maximum sensory blockade(Immediately after injection utp 15–20 minutes post-injection)
研究者
Mohd ubaidullah khan
Vilasrao Deshmukh Government Medical College latur