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临床试验/CTRI/2024/12/077609
CTRI/2024/12/077609尚未招募4 期

Prospective Randomised Comparative Study Of Intrathechal Levobupivacaine And Levobupivacaine With Fentanyl In Infraumbilical Surgeries

D Y Patil Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To assess the time of onset and duration of sensory and motor block and to assess the time of recession of motor block.

研究概览

简要总结

Levobupivacaine is a long acting local anaesthetic which produces differential neuraxial block that is early onset and prolonged duration of sensory block with the shorter duration of motor block and low cardiac toxcitiy. Intrathecal opioids enhance sensory block without prolonging motor and sympathetic block. The aim is to study the efficacy of intrathecal levobupivacaine versus levobupivacaine with fentanyl in infraumbilical surgeries .In the prospective clinical study,after approval from Institutional Ethical Committee and with informed written consent, patients of American Society of Anesthesiologists (ASA) class 1 or class 2 of either sex, between 18 to 60years undergoing elective lower umbilical surgeries will be recruited. After the injection of the spinal medication heart rate and arterial blood pressure will be measured,.motor and sensory block level will be assessed. Arterial pressure and heart rate will be recorded at 2min interval upto 20min and 10min intervals thereafter untill complete regression of the block.The assessments of sensory block done by pinprick test  and Results of the pinprick test were determined bilaterally at midclavicular level by using a short- beveled 27-gauge needle. Motor block in the lower limb was assessed by using a modified Bromage scale (0 - no paralysis, 1-unable to raise extended leg, 2-unable to flex knee, 3-unable to flex ankle). These assessments were performed immediately after the assessments of sensory block until the return of normal motor function.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patient giving consent undergoing infraumbilical surgeries Patients 18-60years Patients of either sex ASA grade I, II.

排除标准

  • Patients who are pregnant Patients known or suspected to have allergy for study drug Patients with any infection at the site of injection.

结局指标

主要结局

To assess the time of onset and duration of sensory and motor block and to assess the time of recession of motor block.

时间窗: Before induction | 5mins , 10 mins , 15mins , 20 mins , 30 min,40mins,50 mins,60 mins and post-operative in the recovery room.

次要结局

  • To assess the intraoperative hemodynamic changes(Before induction)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Juhi Atul Shah

D Y Patil Hospital

研究点 (1)

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