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临床试验/CTRI/2024/08/072640
CTRI/2024/08/072640尚未招募3 期

Comparison of intrathecal Ropivacaine, Levobupivacaine and Bupivacaine for elective hernioplasty: A prospective randomised controlled trial

Dr A Anusha1 个研究点 分布在 1 个国家目标入组 90 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
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Duration of sensory and motor blockade

研究概览

简要总结

Patients who meet the inclusion criteria will be enrolled in the study until adequate sample size is achieved. They will be randomly divided into Groups R, L, B and they will receive 0.75% hyperbaric Ropivacaine, 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine respectively. Code numbers will be written on patients proforma sheet and decoding will be done by the statistician at the end of the study. 3ml of local anesthetic will be given by an anesthetist who is not involved in the study. Data will be recorded by the investigator who is blinded to the drug injected. The onset of sensory blockade is when the patient complains of no pinprick sensation at T10. The highest level of sensory blockade achieved in each group will be noted. Time after injection of intrathecal injection of LA to the injection of first dose of rescue analgesia (Inj. Paracetamol 1gm) will be considered as duration of analgesia. The time of onset of motor blockade will be noted when patient attains bromage 3. The highest level of motor blockade achieved in each group will be noted. Duration of motor blockade is the time from spinal anesthesia till the patient is able to flex at the hip level i.e., bromage 0.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor 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

  • ASA I and II patients.

排除标准

  • Allergic to local anesthetics Unwilling for spinal anesthesia Local site infection Coagulopathy Patients with cardiac, respiratory and hepatic diseases.

结局指标

主要结局

Duration of sensory and motor blockade

时间窗: spinal time, 1st hour, 2nd hour, 3rd hour, every hourly till 24 hours

次要结局

  • -Onset time of sensory and motor blockade(-Maximum sensory and motor level achieved)

研究者

发起方
Dr A Anusha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

A. Anusha

Bhaarath medical college and hospital

研究点 (1)

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