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临床试验/NCT04859049
NCT04859049招募中不适用

Assessing the Effect of Single Injection Infromedial Peribulbar Injection in Lacrimal Duct Intubation Surgery in Adult Patient: Prospective Cohort Study

Research Institute of Ophthalmology, Egypt3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
3
主要终点
Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable pain

研究概览

简要总结

infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking

详细描述

After entering the OR; the patient will be cannulated and fully monitored with basic monitors (pulse oximeter, NIBP & ECG), a nasal cannula is connected to the patient to deliver oxygen.

We gave the patient 5 ml of propofol to decrease the discomfort felt by the patient during injection of local anesthesia. Benox eye drops is applied to the operative eye in both groups.

Patients were allocated into 2 groups; each group is 25 patients Group 1: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid, 0.5ml below the inferior punctum in the lower lid medial margin.

Group 2: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection

During surgery, we will assess the pain degree during probing using Verbal Rating Scale (0 to 10 scale where 0 is no pain an 10 is unbearable pain), to assess the efficiency of this single low volume injection.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults undergoing lacrimal duct intubation surgery
  • Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III.
  • Age between 18-70, both sexes.
  • Axial lengths ranging between 22-28mm.

排除标准

  • Patient age less than 18 or more than 70 years.
  • Coagulation disorders (e.g. patients on warfarin (INR<1.5)
  • Communication difficulties preventing reliable assessment.
  • High myopia (axial length more than 28mm) and medial staphylomas.

结局指标

主要结局

Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable pain

时间窗: during surgery , study will started September 2021 & will end November 2022

pain scale

次要结局

  • surgery satisfaction using yes or no questionnaire(during surgery)

研究者

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

Abeer Samir Salem

Researcher of anesthesia

Research Institute of Ophthalmology, Egypt

研究点 (3)

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