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临床试验/CTRI/2025/04/085580
CTRI/2025/04/085580尚未招募4 期

Comparative study of Sub-Tenons anaesthesia Vs intracameral Vs Peribulbar Anaesthesia for cataract surgery at a Tertiary care eye hospital

Dr PSS SOUJANYA1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Pain relief to the patient intraoperatively and post operatively with visual analogue scale(1 to 10),anxiety (Amsterdam Preoperative Anxiety and Information Scale), ease of doing surgery to the surgeon

研究概览

简要总结

This study aims to compare the effectiveness and adequacy of three different types of anaesthesia viz., Sub-Tenon’s, intracameral and peribulbar anaesthesia in cataract surgery in providing pain relief to the patient, ease of doing surgery to the surgeon and anaesthesia related complications during the surgery. The objectives of the study are to compare patients’ comfort levels during administration of anaesthesia intraoperatively and post operatively. All patients aged 20 - 70 years coming to ophthalmology OPD of ESIC medical college and hospital with cataract and planned for cataract surgery will be subjected to the study after taking informed consent. Patients will be divided into 3 groups using simple randomization. One group will be given sub-tenon’s anaesthesia, second group will be given peribulbar anaesthesia and the third group will be given intra cameral anaesthesia

Patients undergoing the surgery will be questioned immediately after the completion of surgery on parameters such as anxiety (Amsterdam Preoperative Anxiety and Information Scale (APAIS)), pain assessment with visual analogue scale (1 to 10) pre operative, intra operative and post operative, akinesia scored 0 to 2 (0=Total akinesia ,1=Partial akinesia,2= No akinesia) and visual recovery. Patient’s comfort level is scored 1 to 5 (1-Pain/discomfort all the time, 2- Pain/Discomfort many times, 3- Occasional pain but tolerable, 4- Occasional discomfort but no pain and 5 – No pain/discomfort). Patient’s cooperation during the surgery is scored 1 to 5 (1- Repetitive instruction for fixation required [>5], 2- Often has to instruct [3- 5], 3- Few times instruction needed [2], 4- Very less often needed instruction [1], 5- No instruction required after starting surgery). Data on complications associated with type of anaesthetic technique will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 20- 70 years presenting with cataract.

排除标准

  • patients age below 20 years and above 70 years.
  • patients allergic to anesthetic drugs, poor mydriasis less than 5mm, known case of epilepsy, anxiety or psychiatric disorder, inability to lie flat, inability to understand the pain scale or to comply with instructions deafness, mental retardation are excluded.

结局指标

主要结局

Pain relief to the patient intraoperatively and post operatively with visual analogue scale(1 to 10),anxiety (Amsterdam Preoperative Anxiety and Information Scale), ease of doing surgery to the surgeon

时间窗: 24 hours

次要结局

  • anaesthesia related complications during the surgery intraoperatively and post operatively(24 hours)

研究者

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

Dr PSS SOUJANYA

HOD, Dept of Ophthalmology, ESIC Medical College & Hospital, Hyderabad

研究点 (1)

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