Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Anaesthetic Versus General Anaesthesia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.
详细描述
This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases.
The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease.
This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery.
The following measurements will be recorded
- Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery.
- Need for analgesic intake after surgery will be assessed for the first 48 hours
- Complications after surgery as irritation, infection ,and foreign body sensation were assessed
- Patient satisfaction will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with unilateral cataract planned for surgery under topical or general anesthesia
排除标准
- •patients under 20 or over 70 years old Eye infection Patient refusal
研究组 & 干预措施
Group under general anesthesia for cataract surgery
Patients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics
干预措施: General Anaesthesia group (Drug)
Group under topical anaesthesia
Patients will receive topical anaesthesia for cataract surgery
干预措施: Topical Anaesthesia group (Drug)
结局指标
主要结局
Post operative pain
时间窗: At 24 hours, one week and 6 weeks following surgery
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- 1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).(Up to 6 weeks)
研究者
radwa saber
Dr. Radwa Saber, lecturer of Anesthesiology, principal investigator
Alexandria University