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临床试验/CTRI/2024/06/069104
CTRI/2024/06/069104尚未招募Unknown

COMPARISON OF 0.5% ROPIVACAINE- 2% LIDOCAINE COMBINATION VERSUS 0.5% BUPIVACAINE-2% LIDOCAINE COMBINATION FOR PERIBULBAR BLOCK ANAESTHESIA IN MANUAL SMALL INCISION CATARACT SURGERY- AN OBSERVATIONAL STUDY

Dr Sanjeev Kumar Yumnam1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Onset and duration of anesthesia.

研究概览

简要总结

Cataract surgery is one of the most commonly performed surgeries in ophthalmology which is done under regional anesthesia. With the nature of surgery being one that requires precision it is important to make sure that the regional anesthesia administered should provide a good blockade and of adequate duration for which Bupivacaine-Lidocaine combination has been the quintessential drug combination for providing peribulbar block anesthesia for cataract surgeries.

However Bupivacaine has been reported to have cardiovascular and neurological side effects. It can  inhibit cardiac conductivity and contractility and may induce ventricular fibrillations. Neurological adverse effect may include perioral numbness, CNS depression, seizures and respiratory depression.

Ropivacaine, a relatively newer drug on the other hand has a greater margin of safety with lesser cardiovascular and neurological side effects. Studies have been conducted with using 0.75% or 1% Ropivacaine without Lidocaine and not much studies have compared equal concentrations of the two drugs.

With this in consideration this study is designed to compare 0.5%Ropivacaine-2%Lidocaine combination with 0.5%Bupivacaine-2%Lidocaine combination for peribulbar block in manual small incision cataract surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing surgery above 18 years of age and without other co-morbidities.

排除标准

  • Patients with allergy to local anesthetics Post traumatic cataract Myopic with axial length more than 26mm Patients on anticoagulant therapy or with bleeding diathesis.

结局指标

主要结局

Onset and duration of anesthesia.

时间窗: 24 Hours

次要结局

  • To determine surgeon and patient satisfaction and amount of total analgesics required following surgery in the first 24 hours with 0.5%Ropivacaine-2%Lidocaine combination and 0.5%Bupivacaine-2%Lidocaine combination in peribulbar block anesthesia in manual small incision cataract surgery.

研究者

发起方
Dr Sanjeev Kumar Yumnam
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanjeev Kumar Yumnam

Department of Ophthalmology, Mahatma Gandhi Medical College and Research Institute

研究点 (1)

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