A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time Taken to Achieve Adequate Akinesia
研究概览
简要总结
The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.
This was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 years and above
- •Diagnosed with uncomplicated senile cataract
- •Visual acuity of <3/60
排除标准
- •Impaired mental status
- •Difficulty in speaking
- •Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase
- •Previous surgery in the same eye
- •Impaired ocular motility
- •Eyelid abnormalities
- •Patients with only one eye
结局指标
主要结局
Time Taken to Achieve Adequate Akinesia
时间窗: 10 minutes and 15 minutes
Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of \<4 and was evaluated at 10 and 15 minutes.
Supplementary Injection(s)
时间窗: 5 minutes
After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later
Complications of Local Anaesthetic Injection
时间窗: 0,10 and 15 minutes
Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc
Pain Score for Local Anaesthetic Injection
时间窗: 20 minutes
Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
Pain Score for Cataract Surgery
时间窗: 20 minutes
Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain
次要结局
- Volume of Anaesthetic Drug (ml)(10 and 15 minutes)
- Total Number of Injections(15 minutes)
- Surgeon Satisfaction Score for Local Anaesthetic Block(20 minutes)
- Acceptability of the Anaesthetic Block to the Subject(25 minutes)
- Duration of Cataract Surgery (Minutes)(At the end of surgery)