Comparison of effects of mixed versus sequential adminstration of levobupivacaine and fentanyl in subarachnoid block for lower limb surgeries:A randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.To compare subarachnoid block characteristics after mixed versus sequential administration of levobupivacaine and fentanyl for lower limb surgeries.
研究概览
简要总结
Subarachnoid block is the most commonly used anaesthesia technique for lower limb surgeries. Opioids are the most commonly used adjuvants with local anesthetics (LA). Adjuvants are given premixed with LA loaded in a single syringe. This study was conducted to evaluate differences in characteristics of sensory and motor block,hemodynamic parameters and post operative pain whilst administering isobaric Levobupivacaine and fentanyl either in a single syringe or different syringes. The effect of administering opioid prior to LA and vice versa on these parameters was also assessed. Methods: One hundred and twenty patients were randomly allocated into three groups of 40 each: Group A received premixed 0.5% isobaric levobupivacaine 3 ml (15 mg) and 0.5 ml (25 microgram) of fentanyl in a single 3.0 ml syringe, Group B received 0.5 ml (25 microgram) of fentanyl in a 3.0 ml syringe followed by 0.5% isobaric levobupivacaine 3ml (15 mg) in a 3.0 ml syringe, Group C received 0.5% isobaric levobupivacaine 3ml (15 mg) in a 3.0 ml syringe followed by 0.5 ml (25 microgram) fentanyl in a 3.0 ml syringe. All statistical calculations were done using SPSS 21 version statistical program for Microsoft Windows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
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 of age between 18-65 years.
- •American Society of Anaesthesiologists (ASA) grade I&II Scheduled for lower limb surgeries under subarachnoid block.
排除标准
- •Patient refusal to participate in the study 2)Any History of allergy to the study medication 3)Any history of clotting or bleeding disorder 4)Infection at the site of lumbar puncture 5)Patients with pre existing neurological deficit 6)Any history of psychiatric illness Pregnant patients.
结局指标
主要结局
1.To compare subarachnoid block characteristics after mixed versus sequential administration of levobupivacaine and fentanyl for lower limb surgeries.
时间窗: 1)Sensory block was assessed by a sterile pin prick every 2 min till 20 min and then after every 10 min till the highest level was achieved. | 2)Onset was defined as the loss of sensation at T10 dermatome. The time to onset of motor block was defined as time taken to reach Modified Bromage score of 4. | 3)Time of regression of motor block was assessed as time to reduce to from maximum attained Modified Bromage score to score of 0.
2.To compare intraoperative hemodynamic parameters between the three groups.
时间窗: 1)Sensory block was assessed by a sterile pin prick every 2 min till 20 min and then after every 10 min till the highest level was achieved. | 2)Onset was defined as the loss of sensation at T10 dermatome. The time to onset of motor block was defined as time taken to reach Modified Bromage score of 4. | 3)Time of regression of motor block was assessed as time to reduce to from maximum attained Modified Bromage score to score of 0.
次要结局
- 1.To compare the duration of postoperative analgesia between the three groups.(2.To evaluate opioid related side effects in the three groups.)