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临床试验/NCT02151968
NCT02151968Unknown不适用

Traditional Blind Versus Ultrasound-guided Peribulbar Blockade

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Failure of peribulbar block

研究概览

简要总结

Eye surgeries are traditionally performed under local anaesthesia with a peribulbar block. This is a blind technique where local anaesthetic is injected into the back of the eye to make the eye numb and motionless for surgery. This is a blind injection and can be associated with complications such as bleeding, rupture of eye globe, blindness, increasing the pressure of the eye etc. It also has a high failure rate resulting in need for additional injections, further exposing the patient to possible complications. The investigators propose to perform the peribulbar block with ultrasound to guide the block needle placement and injection. The investigators hypothesize that ultrasound guided peribulbar blocks would have higher success rate (less need for additional injections) and that the total amount of local anaesthetics used would be decreased.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing vitrectomy surgery

排除标准

  • •Lack of informed consent
  • •Coagulopathic disorder, anticoagulated with INR (international normalized ratio) > 1.5 or platelet count less than 75 x 10^9/L
  • •Pathological myopia. Inability of patient to lie down for 2 hours for the operation -Local infection at site of needle entry

研究组 & 干预措施

Ultrasound-guided peribulbar block

Experimental

干预措施: Local Anaesthetic Injection (Procedure)

Ultrasound-guided peribulbar block

Experimental

干预措施: Ultrasound-Guidance (Procedure)

Traditional blind peribulbar block

Active Comparator

干预措施: Local Anaesthetic Injection (Procedure)

结局指标

主要结局

Failure of peribulbar block

时间窗: 10 minutes after block performed

Ocular Anaesthetic Scoring System (OASS) score of less than 10 will be considered inadequate for surgery and a block failure.

次要结局

  • Quality of the block(5 and 10 min after block performed)
  • Incidence of Supplemental Peribulbar injections(Operative day 0)
  • Volume of Total Local Anaesthetic Used(Operative day 0)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Paul McHardy

Lecturer

Sunnybrook Health Sciences Centre

研究点 (1)

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