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临床试验/CTRI/2022/11/047664
CTRI/2022/11/047664尚未招募不适用

Comparative study of Intra thecal 0.5% isobaric Ropivacaine versus 0.5% isobaric Levo bupivacaine in unilateral hernia surgeries

MALBAR MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年1月12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
90
试验地点
1
主要终点
To compare duration of motor and sensory blockade of intrathecal 0.5% isobaric levobupivacaine with 0.5% isobaric ropivacaine

研究概览

简要总结

A comparative study of intrathecal 0.5% levobupivacaine versus 0.5% ropivacaine  in unilateral inguinal hernia surgeries was proposed as a study to compare duration of motor and sensory blockade as primary objective. Secondary objective being to compare the onset time to maximum sensory and motor blockade and hemodynamic parameters and our hypothesis is that levobupivacaine has prolonged duration of sensory and motor blockade which is better for prolonged surgeries and ropivacaine has shorter duration of motor blockade which is preferred for faster recovery and early ambulation and hence the latter can be administered for daycare surgeries. It is also beneficial in context of decreasing the incidence of urinary retention .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA 1 & 2 patients 2.Scheduled for unilateral inguinal hernia surgeries.

排除标准

  • 1.Patients not willing to participate in the study
  • Contra indications to spinal anaesthesia ( INR>1.3, platelet count <75000)
  • ASA 3,4 patients
  • Neurological diseases like multiple sclerosis, lumbar disc herniation etc...
  • Allergy to local anaesthetics.

结局指标

主要结局

To compare duration of motor and sensory blockade of intrathecal 0.5% isobaric levobupivacaine with 0.5% isobaric ropivacaine

时间窗: After giving spinal blood pressure and heart rate will be checked every one minute for 10 mins and every 5 mins for next 1 hour and then every 15 mins until the end of the surgery.Sensory and motor blockade will be assessed every 3 min for 15 min and every 10 min for 45 min,every 15 min for 90 min and finally 30 min thereafter until sensory block regress to S2 dermatome.

次要结局

  • 1.onset of action(2.time to maximum sensory and motor blockade)

研究者

发起方
MALBAR MEDICAL COLLEGE
申办方类型
Private medical college

研究点 (1)

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