A Prospective Comparative Study Between an Atraumatic Peribulbar Block and the Traditional Peribulbar Needle Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safe Ophthalmic block using Globe Akinesia Score by Sarvela
研究概览
简要总结
This study is conducted to determine the efficacy of the cannula atraumatic technique as an alternative to the traditional needle penetrating technique to minimize the incidence of accidental globe penetration and/ or perforation, as the plastic part of the cannula is blunt and is difficult to perforate the normal globe being marble-like in consistency.
详细描述
A prospective comparative single blinded randomized controlled clinical study was held in the operating theatre at Research institute of ophthalmology, on adult patients with age group between 18- 80 years of both sexes undergoing anterior, posterior segment or plastic surgeries. two techniques were used in comparison: the atraumatic technique, using a 20 or 22-gauge cannula advanced in the inferior-temporal peribulbar space after local infiltration. The skin and the conjunctiva will be pierced by the cannula and advanced for only 0.5 cm, then the cannula will be advanced blindly. Supplementation using the other sites (medial canthus and superior nasal) as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
the participant is going to have regional ophthalmic anesthesia, by either the atraumatic or the needle technique without being informed by which technique he is going to receive the block
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
- 否
入选标准
- •Adult patients
- •patients going to do anterior, posterior segment surgery or cornea surgeries.
排除标准
- •Pediatric population
- •Mentally retarded patients
- •Patients having Problems to lie flat, refused to take regional
- •Patients with communication problems as; language barrier, deaf and mute.
- •Patients with bleeding diathesis.
研究组 & 干预措施
Atraumatic Peribulbar Technique
a cannula is used to apply ophthalmic block
干预措施: Cannula plastic part while applying peribulbar block (Device)
Conventional peribulbar block
a 24 or 25 gauge needle is used to provide regional o anesthesia to the study group
干预措施: traditional technique (Procedure)
结局指标
主要结局
Safe Ophthalmic block using Globe Akinesia Score by Sarvela
时间窗: 3 years
A scoring system out of 12 to assess the four recti muscles, orbicularis oculi and the levator palpebri superioris degree of akinesia post regional anesthesia where 2 is full movement 0 is total block, and also the anesthesia is assessed where 2 is full sensation and 0 is considered total anesthesia
次要结局
未报告次要终点
研究者
Dina Moustafa Mohamed
Researcher of Anesthesia- Research Institute of Ophthalmology
Research Institute of Ophthalmology, Egypt