A Placebo Controlled study to compare two doses of intra-venous dexamethasone for Prolongation of analgesia in axillary Brachial plexus block .
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of analgesia is compared between 3 groups of axillary brachial plexus block.
研究概览
简要总结
It is a Placebo Controlled study in which we compare 2 doses of I/v dexamethasone (4mg vs 8mg) for Prolongation of analgesia in axillary brachial plexus block .written informed consent will be taken from all the patients.Data will be compiled and analysed with good statistical test .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I-III patients undergoing elective below mid arm surgeries under axillary Brachial plexus block and duration of surgery should be less than 3 hours.
排除标准
- •local infection at injection site or sepsis 2)allergy to any local anaesthetic 3)pt.with known coagulopathy or an anticoagulant therapy 4)pt with GERD,cataract ,glaucoma 5)steroid use within 2 weeks of study period 6)systemic fungal infection ,viral infection 7)patient with nerve entrapment or neuropathy after trauma or diabetic neuropathy and uncontrolled diabetes.
- •patient who refuse to give consent 5).
结局指标
主要结局
Duration of analgesia is compared between 3 groups of axillary brachial plexus block.
时间窗: We will assess efficacy of block at 30min after block . | We will assess VAS score at | 1)Baseline(preblock) | 2) every 1 hourly till 4 hours | 3) every 30min till 6 hours | 4) 24 hour
1)d0-i/v NS given
时间窗: We will assess efficacy of block at 30min after block . | We will assess VAS score at | 1)Baseline(preblock) | 2) every 1 hourly till 4 hours | 3) every 30min till 6 hours | 4) 24 hour
2)d1-i/v 4mg dexamethasone given
时间窗: We will assess efficacy of block at 30min after block . | We will assess VAS score at | 1)Baseline(preblock) | 2) every 1 hourly till 4 hours | 3) every 30min till 6 hours | 4) 24 hour
3)d2-i/v 8mg dexamethasone given
时间窗: We will assess efficacy of block at 30min after block . | We will assess VAS score at | 1)Baseline(preblock) | 2) every 1 hourly till 4 hours | 3) every 30min till 6 hours | 4) 24 hour
次要结局
- 1)Block characteristics (onset and duration )(2)no.of attempt taken for block)
研究者
Dr Mangal Ahlawat
PGIMS Rohtak