A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- verbal pain numerical scaling
研究概览
简要总结
comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.
详细描述
In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection
All patients are informed that they are going to receive topical anaesthetic agent before the IVI.
pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients between 30 to 70 years
排除标准
- •uncooperative patients
研究组 & 干预措施
bupivacaine 0.5%
干预措施: bupivacaine 0.5% and oxubuprocaine (Drug)
oxybuprocaine
干预措施: bupivacaine 0.5% and oxubuprocaine (Drug)
结局指标
主要结局
verbal pain numerical scaling
时间窗: 10 minutes
11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain
次要结局
未报告次要终点