A Prospective, Randomised, Single-masked Comparison of Retrobulbar Anesthesia, Peribulbar Anesthesia and Topical Combined Subconjunctival(Two-step) Anesthesia in Posterior Vitrectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pain scores
研究概览
简要总结
A prospective, randomised, single-masked comparison of local anaesthetic approaches including topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy（TAMIV）vs peribulbar block vs retrobulbar block
详细描述
Purpose: topical anesthesia combined sub-conjunctival anesthesia(two-step anesthesia) for minimally invasive vitrectomy Methods: This prospective, randomized, single-blinded clinical trail is conducted at Shanghai Aier Eye Hospital. Selected group of 60 patients with retinal-vitreous diseases will be randomized divided into 3 groups and underwent 25-gauge vitrectomy. Group1 uses two-step anesthesia , whereas Group 2 uses retrobulbar anesthesia, group 3 uses peribulbar anesthesia. A 5-point Visual Analogue Pain Scale is used to assess patients' pain score and surgeon's ease while operating. Any complications therefore will be made note of.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proliferative diabetic retinopathy (PDR);
- •Vitreous haemorrhage (VH);
- •Retinal detachment (RD);
- •Retinal vein occlusion(RVO);
- •Other diseases (idiopathic macular hole, macular pucker and high myopic maculopathy);
- •Silicone oil-filled eye.
排除标准
- •Communication problems;
- •Allergy to amide-type local anaesthetic agents;
- •History of vitreoretinal surgery or orbital surgery;
- •Orbital deformity;
- •With episcleral adjunct surgery;
- •Keratitis;
- •Conjunctivitis and active uveitis.
研究组 & 干预措施
retrobulbar anesthesia group
2% lidocaine 4ml injected into retrobulbar space
干预措施: retrobulbar anesthesia (Procedure)
peribulbar anesthesia group
2% lidocaine 4 to 8ml injected into peribulbar space
干预措施: peribulbar anesthesia (Procedure)
two step anesthesia group
conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection
干预措施: two step anesthesia (Procedure)
结局指标
主要结局
pain scores
时间窗: During surgery
5-point Visual Analogue Pain Scale(VAPS): Grade 1: No pain or discomfort; Grade 2: mild pain or discomfort; Grade 3: moderate pain or discomfort; Grade 4: severe pain or discomfort;
次要结局
- surgeon's ease(During surgery)