CTRI/2021/08/035857尚未招募不适用
Comparison of effectiveness between Transdermal Buprenorphine and Diclofenac patch for post operative analgesia in major orthopaedic lower limb surgeries under spinal anaesthesia: prospective double blinded randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To compare the post-operative analgesia by visual analogue scale between both groups
研究概览
简要总结
After taking approval from ethics committee, study will be initiated on patients fulfilling inclusion criteria, patients will be assessed for post operative pain according to VAS scale, need for rescue analgesia with in 24 hours of post operative period and side effects like nausea, vomiting and pruritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator 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
- •1.Elective and emergency orthopaedic surgery patients with lower limb long bone fractures 2.Age group:18-60 years 3.ASA grade I- III.
排除标准
- •1.Patients having injuries over other parts of body rather than lower limb 2.Altered coagulation profile and spinal deformities(Kyphosis, Scoliosis) 3.Suffering from respiratory disease, severe hepatic and renal dysfunction 4.Pregnant and lactating mother 5.Hypersensitivity to study drugs.
结局指标
主要结局
1.To compare the post-operative analgesia by visual analogue scale between both groups
时间窗: 24 HOURS
2.To compare frequency of need for rescue analgesia between both groups
时间窗: 24 HOURS
次要结局
- 1.To compare change in pulse rate, mean arterial pressure, Spo2, respiratory rate between both groups.(2.To compare the proportion of post-operative nausea, vomiting, PruritiS between both groups)
研究者
研究点 (1)
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