Comparative Study Between Peribulbar Block Technique and Sub-Tenon's Technique in Adult Patients Undergoing Redo Vitreoretinal Surgery: RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- intraoperative pain
研究概览
简要总结
To compare the efficacy and efficiency of peribulbar block versus sub-Tenon's capsule injection of local anesthetic in redo vitreoretinal surgery
详细描述
Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.5% bupivacaine with 60 IU hyalouronic acid.
The primary outcome measured was intraoperative eye pain, which was rated by patients in both groups using an 11-point (0-10) numerical visual analogue scale immediately after.
The surgeons indicated whether they perceived patient discomfort during 4 different stages of the operation: opening of the conjunctiva, vitrectomy (if performed), placement of scleral buckle (if performed) or using the laser probe, and closing of the conjunctiva.
The need for supplemental local anesthesia, and use of IV sedation for additional pain control intraoperatively were compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 80
排除标准
- •Uncooperative patients
- •Bleeding disorders
- •High axial length (30mm) with previous buckle surgery
研究组 & 干预措施
subtenon's block
we use the subtenon cannula to inject the local anesthetic mixture
干预措施: peribulbar block versus subtenon's block (Procedure)
peribulbar block
we use the usual 25G sharp needle to inject the local anesthetic mixture
干预措施: peribulbar block versus subtenon's block (Procedure)
结局指标
主要结局
intraoperative pain
时间窗: during whole surgery duration (around 2 hours)
11 point verbal rating score from 0 to 10 where 0 is no pain and 10 is intolerable pain patient will be asked immediately after surgery about pain the need for intraoperative sedation will be recorded
次要结局
未报告次要终点
研究者
Abeer Samir Salem
Researcher of anesthesia
Research Institute of Ophthalmology, Egypt