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临床试验/CTRI/2024/11/076909
CTRI/2024/11/076909尚未招募不适用

Effect of Interscalene Block on Intraocular Pressure and Ocular Perfusion Pressure in Upper Limb Surgeries: An Observational study

Dr Shrisha Hiremath1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Intraocular Pressure

研究概览

简要总结

TITLE :EFFECT OF INTERSCALENE BLOCK ON INTRAOCULAR PRESSURE AND OCULAR PERFUSION PRESSURE IN UPPER LIMB SURGERIES: AN OBSERVATIONAL STUDY.

Keywords: Interscalene Block, Ocular Perfusion Pressure, Intraocular pressure, Mean arterial pressure.

Introduction:. Interscalene block(ISB) causes changes in Intraocular pressure(IOP) and Ocular perfusion pressure(OPP) as it blocks cervical sympathetic ganglia innervating ciliary blood vessels which are major source of  Aqueous humour production.

Methods: After Institutional Ethical Clearance(KIMS/IEC/A152/M/2024), Prospective observational study for period of 6 months, with sample size 80 (80 eyes=40 patients) will be started.  ASA I, II patients aged 18-60 posted for elective upper limb surgeries will be included after excluding glaucoma, cataract and patients contraindicated for ISB.

Under USG guidance, ISB will be performed and Local anaesthetic=10ml Lignocaine(21.3mg/ml)+Adrenaline(0.005mg/ml)+10ml 0.5% Bupivacaine(5mg/ml) would be administered.

Post ISB Intraocular pressure (IOP) will be measured periodically using Easyton Trans-palpebral tonometer, on blocked side(case) and unblocked side(control eye) along with mean arterial pressure(MAP).

OPP will be calculated using equation ,OPP=(95/140*MAP)-IOP.

Repeated measures ANOVA will be used to test IOP and OPP difference in the blocked and unblocked eye at every 5 minutes after ISB (this will be done as per the planned time periods ).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective upper limb surgeries.
  • Also, Patients belonging to ASA 1 and 2 according to American Society of Anaesthesiologists Physical status classification.

排除标准

  • Patients already diagnosed to have glaucoma, cataract.
  • Patients with contraindications to brachial plexus blocks (coagulopathies, severe respiratory disease, contralateral phrenic nerve paralysis).
  • Patients diagnosed to have Horner’s syndrome in the past or bell’s palsy or diagnosed to have stroke or head injury in the past.
  • Patients proved to have allergic/ hypersensitivity to local anaesthetics.
  • Pre-existing acute or chronic eye disease or had eye injury /penetrating ocular injury in the past or had history of eye surgery
  • Use of ß blockers, Ca channel blockers, statins and nitrates which influence IOP
  • Pregnant females .
  • Patients who refuse to take part in study.

结局指标

主要结局

Intraocular Pressure

时间窗: 0,5,10,15,20,25,30,35,40,45,50,55,60th Minute

次要结局

  • Ocular Perfusion Pressure(0,5,10,15,20,25,30,35,40,45,50,55,60th Minute)

研究者

发起方
Dr Shrisha Hiremath
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ashwini A

Kempegowda Institute of Medical Sciences , Bangalore, Karnataka, India

研究点 (1)

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