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临床试验/CTRI/2024/09/074075
CTRI/2024/09/074075招募中3 期

Efficacy of peribulbar block with the combination of 2 percent lidocaine and 0.75 percent ropivacaine versus 2 percent lidocaine and 0.5 percent bupivacaine in cataract surgery ; a randomised controlled trial.

NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To compare efficacy of combination of 2% lidocaine with 0.75% ropivacaine and 2% lidocaine with 0.5% bupivacaine for peribulbar block in patients undergoing cataract surgery with respect to :

研究概览

简要总结

This study is a randomised, double blind  study to compare the effectiveness of two different drug combinations - 2% lidocaine with 0.75% ropivacaine and 2% lidocaine with 0.5% bupivacaine - in terms of duration of sensory blockade, motor blockade and post operative analgesia  in patients undergoing small incision cataract surgery. Either of the drug  combinatons depending on the study group, will be used as an anaesthetic agent of induction for peribulbar block in a total of 80 patients, divided into groups of 40 each and suffering from various types of cataract. This study will be conducted in the department of Anaesthesia at a tertiary care centre in Nagpur. 

The hemodynamic stability in terms of heart rate, systolic ,diastolic and mean arterial blood pressure , oxygen saturation along with side effects like nausea and vomitiing will be monitored from the time of application of the block till the end of procedure.

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
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1} patients of ASA 1 and 2 2} patients posted for small incision cataract surgery.

排除标准

  • 1} patients having local sepsis, glaucoma, coagulation abnormality.
  • 2} patient refusal 3} uncooperative patient.

结局指标

主要结局

To compare efficacy of combination of 2% lidocaine with 0.75% ropivacaine and 2% lidocaine with 0.5% bupivacaine for peribulbar block in patients undergoing cataract surgery with respect to :

时间窗: 1)Post operative pain assessment will be done every half hour for 2 hours and hourly for 6 hours. | 2)24 hrs analgesic requirement will be noted

1} onset of sensory blockade {in minutes}

时间窗: 1)Post operative pain assessment will be done every half hour for 2 hours and hourly for 6 hours. | 2)24 hrs analgesic requirement will be noted

2}onset of motor blockade {in minutes}

时间窗: 1)Post operative pain assessment will be done every half hour for 2 hours and hourly for 6 hours. | 2)24 hrs analgesic requirement will be noted

3} duration of post operative analgesia {in minutes}

时间窗: 1)Post operative pain assessment will be done every half hour for 2 hours and hourly for 6 hours. | 2)24 hrs analgesic requirement will be noted

次要结局

  • To compare the combination of 2% lidocaine with 0.75% ropivacaine & 2% lidocaine with 0.5% bupivacaine in patients undergoing cataract surgery under peribulbar block with respect to :(1} hemodynamic stability)

研究者

发起方
NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prajakta Mehare

NKP Salve institute of medical sciences

研究点 (1)

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