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临床试验/CTRI/2025/06/089006
CTRI/2025/06/089006尚未招募3 期

Comparison of hyperbaric solutions of Bupivacaine, Levobupivacaine and Ropivacaine in Spinal anaesthesia for elective surgery: A prospective, Randomised, double-blind study

HBTMC and Dr RN Cooper hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年6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
75
试验地点
1
主要终点
Onset and duration of sensory blockade with the three drugs

研究概览

简要总结

We are comparing bupivacaine with ropivacaine and levobupivacaine with the aim of studying clinical efficacy of hyperbaric bupivacaine, levobupivacaine and ropivacaine with respect to sensory and motor block characteristics, haemodynamic parameters and adverse effects.

Seventy five patients satisfying the inclusion and exclusion criteria undergoing elective lower limb and lower abdominal surgeries will be  enrolled in our study after obtaining written informed consent.  Patients will be  randomly       allocated into 3 groups of 25 each, receiving3 ml of 0.5% hyperbaric bupivacaine, levobupivacaine and ropivacaine.

All data will be  compiled in a case record form. Data will be analysed using SPSS v21. Chi square test will be  used as test of significance for categorical data and ANOVA test will be used as test of significance for continuous data (comparison of three groups means). Post hoc comparative analysis will be  done to determine statistical significance among the three groups. P value less than 0.05 would considered as statistically significant.

The demographic data such as age, sex, height, weight and ASA grades, operative procedures and duration of surgery would be collected.

Parameters noted in case record form will be :

  • Mean Time of onset of sensory block (T8)
  • Mean Time to reach peak sensory block
  • Maximal sensory level was assessed;
  • Time for 2 segment regressions of sensory level
  • The mean Duration of sensory blockade (Tanes)
  • The mean Onset time of motor blockade
  • The mean Duration of Motor Blockade
  • Haemodynamic parameters like pulse rate, blood pressure, respiratory rate and saturation
  • Mean arterial pressure
  • The mean Time taken to Walk without support
  • The mean Time taken to Void
  • Perioperative adverse events

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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.

排除标准

  • ASA III and IV Blood Dyscrasias Clotting disorders Pregnant and Lactating History of hypersensitivity disorders Pain modifying drugs.

结局指标

主要结局

Onset and duration of sensory blockade with the three drugs

时间窗: assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely

次要结局

  • 1.Onset & duration of motor blockade(2. Effect on heart rate)

研究者

发起方
HBTMC and Dr RN Cooper hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aishani Chawla

H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai

研究点 (1)

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