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临床试验/CTRI/2024/07/071082
CTRI/2024/07/071082尚未招募4 期

A Randomised controlled study comparing Hyperbaric Levobupivacaine 0.5 percent with Hyperbaric Bupivacaine 0.5 percent for its efficacy in Spinal Anaesthesia for lower abdominal and lower limb surgeries

D Y Patil Hospital1 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5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the clinical efficacy of hyperbaric bupivacaine 0.5% and hyperbaric levobupivacaine 0.5% in spinal anaesthesia based on onset of motor block

研究概览

简要总结

60 patients of ASA class I or class II of either sex, between 18-65 years undergoing elective lower abdominal and lower limb surgeries and who gave written informed consent for the study, will be recruited and randomized .After clinical assessment and routine investigations , they will randomly be allocated into two groups containing 30 patients each.

Group A will receive spinal anaesthesia using 3.2 ml of 0.5% bupivacaine heavy.

Group B will receive spinal anaesthesia using 3.2 ml of 0.5% Levobupivacaine heavy.

After taking the patient inside the operation theatre, the monitors will be placed and continuous monitoring will be done. After the injection of the spinal medication, heart rate and arterial blood pressure will be measured. Arterial pressure and heart rate will be recorded at 2min interval upto 20min and 10min intervals thereafter until 60 mins  followed by 30mins till 180mins.

The assessments of sensory block done by pinprick test and Results of the pin rick test were determined bilaterally at midclavicular level by 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 will be performed immediately after the assessments of sensory block until the return of normal motor function. The measurement will also include peak block height, motor and sensory blockade, duration and side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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.Patient undergoing abdominal and lower limb surgeries under spinal anaesthesia 2.ASA 1 and 2.

排除标准

  • 1.Known hypersensitivity to amide local anaesthetics 2.Contraindications for spinal anaesthesia 3.Bleeding disorders or on anti-coagulant therapy , documented neuromuscular therapy 4.Any infection at the injection site 5.Any spinal deformity 6.Pregnant patients.

结局指标

主要结局

To compare the clinical efficacy of hyperbaric bupivacaine 0.5% and hyperbaric levobupivacaine 0.5% in spinal anaesthesia based on onset of motor block

时间窗: every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins

次要结局

  • Time taken for complete motor blockade , onset of sensory blockade, duration of sensory and motor blockade and hemodynamic parameters(every 2 mins for first 20mins followed by every 10mins till 60mins then every 30mins till 180mins)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Noopur Choudhary

D Y Patil Hospital

研究点 (1)

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