To study the utility of ultrasound guided block for analgesia in patients of acute limb injuries presenting to emergency department: a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To study and compare the pain score reduction during initial six hours of intervention
研究概览
简要总结
In patients of traumatic fractures presenting with severe pain usually intravenous fentanyl or morphine is given. But these opiods have their own share of problems including respiratory depression, hypotension and future addiction.
So in this study we are comparing efficacy of blocking the nerve supplying the fracture area using local anaesthetic agents in reducing pain over a period of six hours with respect to intravenous fentanyl.
This nerve block strategy is already being used in operation theatre. But in this study we are trying to utilise this technique in emergency department in traumatic fracture patients.
This study is a prospective, open label, randomized control trial of parallel groups to compare efficacy of site specific nerve block versus conventional opiod therapy in traumatic fracture patients in successfully alleviating pain in an emergency department. Patients presenting to emergency department after traumatic fractures, giving consent, meeting inclusion and exclusion criterion are randomized into intervention group of nerve block versus control group of intravenous fentanyl. The procedure is done ultrasound guided and time is noted. The pain scores are noted at 1 hour, 3 hours and 6 hours of procedure. Then both pain scores are compared as the primary outcome. In secondary outcome we would study total duration of emergency department stay and whether intervention is reducing the stay, total time taken to do the intervention, study and compare the complications in both groups and reduction in opiod dose by nerve block in 6 hours period.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult of both gender from eighteen to eighty years presenting to emergency department with history of trauma and triaged as yellow or green and having upper or lower limb fractures with on arrival pain score greater than or equal to seven and patient or legally authorized representative gives consent.
排除标准
- •Patient or legally authorized representative is unable or unwilling to give consent or red triaged patients or patients with unstable vitals on arrival or less than eighteen years or greater than eighty years or patients with life threatening comorbidities or history of hypersensitivity or known contraindication to local anaesthetics or pain score less than seven.
结局指标
主要结局
To study and compare the pain score reduction during initial six hours of intervention
时间窗: 1hour,3hour,6hour
次要结局
- To study the length of emergency department stay(In hours)
- To study complications of block procedure & compare with complications of opiod usage(Over 6 hours)
- To study the time taken to reduce the pain after intervention(In minutes)
- To study the time taken to do the procedure(In minutes)
- To study the reduction in opiod usage due to block procedure(Over 6 hours)
研究者
Dr. Barada Prasad Debasish Panda
All India Institute of Medical Sciences, New Delhi