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临床试验/CTRI/2024/08/071980
CTRI/2024/08/071980招募中不适用

A Comparative study on efficacy of combination of 0.5 percentage Ropivacaine and 2 percentage lidocaine versus combination of 0.5 percentage Bupivacaine and 2 percentage lidocaine for peribulbar anaesthesia in cataract surgery

Dr Rohini Kanagarajan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Effectiveness of block , onset and total duration of sensory and motor blockade

研究概览

简要总结

This is a prospective, randomized, double blinded study to compare the effectiveness of  block characteristics and side effect profile of a mixture of 0.5% Ropivacaine and 2% Lidocaine with a mixture of 0.5% Bupivacaine and 2% Lidocaine for peribulbar block in cataract surgery.

The primary objective of the study is to evaluate the peribulbar block efficacy by assessing the onset of block and total duration of sensory and motor block. The secondary objective is to assess the adverse reactions and immediate systemic complications associated with the medication, to know the patient and surgeon satisfaction with the analgesia and anaesthetic technique.  By doing this study, if we establish that efficacy of Ropivacaine is on par with Bupivacaine with better side effect profile, we can implement regular usage of Ropivacaine for peribulbar anesthesia in cataract. Many patients posted for cataract surgery are elderly people with multiple systemic diseases. Through this study, if this novel anesthetic medication, Ropivacaine is proved to have better efficacy and safety profile, it can replace the usage of the traditional anesthetic medication which is associated with cardiovascular and neurological adverse effects.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of age more than 18 planned for elective cataract surgery and IOL implantation at ESIC with ASA 1 and ASA 2.

排除标准

  • Any preceeding ocular diseases other than cataract, orbital anomalies, patients with known severe impairment of coagulation, severe systemic diseases and Axial length of eyeball more than 26mm.

结局指标

主要结局

Effectiveness of block , onset and total duration of sensory and motor blockade

时间窗: 10 minutes, 24 hours

次要结局

  • adverse effects and complications associated with the medication during surgery and first 24 hours postoperative period, surgeon and patient satisfaction with analgesia and technique(24 hours)

研究者

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

Dr Rohini Kanagarajan

ESIC Medical College and Hospital, Hyderabad

研究点 (1)

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