CTRI/2024/11/076139尚未招募4 期
COMPARISON OF LEVOBUPIVACAINE AND LEVOBUPIVACAINE WITH FENTANYL IN POPLITEAL BLOCK USING ULTRASOUND FOR BELOW-KNEE SURGERIES-RANDOMISED CLINICAL TRAIL.
dr snehitha1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年11月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 2)To compare the duration of postoperative sensory analgesia in both the groups
研究概览
简要总结
AIM
To compare the efficacy of 0.5%Levobupivacaine and 0.5%Levobupivacaine with fentanyl intraoperatively and postoperatively in the ultrasound guided popliteal block for below-knee surgeries
NEED FOR THE STUDY
- Regional anesthesia is better alternative to general anesthesia in limb surgeries for patients with comorbidities as general anaesthesia changes patients hemodynamic status
- Peripheral nerve blocks reduce the requirement of intravenous analgesia and provide intraoperative as well as postoperative analgesia
- Popliteal block for below-knee surgeries provides hemodynamic stability, profound analgesic effect, avoids systemic complications,and allows early discharge from PACU
- Ultrasound guidance shortens block onset time,allows dose reduction of local anaesthetic drug,reduces the number of needle passes and increases success rate with improved block quality
- Levobupivacaine is safer,has less cardiovascular and neurological toxicity and provides comparable motor blockade as Bupivacaine
- therefore,study will be done to assess the effect of narcotic drug,Fentanyl in popliteal blockade HYPOTHESIS 0.5%Levobupivacaine with fentanyl is more efficacious than sole 0.5%Levobupivacaine in popliteal block for below-knee surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will be done in patients of ASA grades I and II posted for below knee surgeries.
排除标准
- •ASA grade III and IV 2)Local infection at the site of injection 3)History of allergy to local anaesthetic drug 4)Pregnant women.
结局指标
主要结局
2)To compare the duration of postoperative sensory analgesia in both the groups
时间窗: Till first rescue analgesic request
1)To compare the onset of sensory analgesia and duration of motor blockade
时间窗: Till first rescue analgesic request
intraoperatively
时间窗: Till first rescue analgesic request
次要结局
- 1)To compare intraoperative and postoperative hemodynamic variables such as heart rate,non-invasive blood pressure and oxygen saturation(2)To observe adverse effects like Hypotension,Bradycardia,nausea,vomiting,nerve injury,LAST(Local Anesthetic Systemic Toxicity),hematoma)
研究者
DRKOPPU NAGA SAI SNEHITHA
BLDE (DEEMED TO BE UNIVERSITY).
研究点 (1)
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