Vibration-Assisted Anaesthesia: A Randomised Controlled Trial to Investigate Whether Vibration Reduces the Pain of Anaesthetic Injection in Eyelid Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.
研究概览
简要总结
Aim of study is to investigate whether a small, non-invasive vibrating device applied to the forehead during local anaesthetic administration reduces the pain of the injection.
详细描述
Purpose:
To carry out a prospective randomised controlled clinical trial to compare the efficacy of vibration in reducing the pain of local anaesthetic injections into the upper eyelid.
Hypothesis:
Vibration of the adjacent soft tissue reduces the pain of anaesthetic injections in upper eyelid surgery.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (> 16 years) undergoing bilateral upper eyelid surgery under local anaesthetic who have given fully informed consent to be in the trial
排除标准
- •Age less than 16 years
- •Previous upper eyelid surgery
研究组 & 干预措施
1
Group receiving vibration-assisted anaesthesia
干预措施: Vibration-assisted anaesthesia (Procedure)
2
Group receiving switched-off vibrating device
干预措施: Switched-off vibrating device (Procedure)
结局指标
主要结局
Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.
时间窗: Immediately
次要结局
未报告次要终点