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临床试验/CTRI/2025/06/088008
CTRI/2025/06/088008尚未招募不适用

Comparative study of intrathecal fentanyl vs butorphanol along with heavy levobupivacaine for analgesic efficacy in adult patients undergoing elective infra umbilical surgery

Dr Sarvjeet kaur1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年6月15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
180
试验地点
1
主要终点
To evaluate the duration of sensory and motor block

研究概览

简要总结

Spinal anaesthesia is one of the most common regional anesthetic

techniques used for lower abdominal and lower limb surgeries. Levobupivacaine is a

new long-acting local anesthetic agent.

Aims and Objectives:

To evaluate duration of sensory block with intrathecal 0.5 % levobupivacaine

and 25 µg fentanyl.

To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine

and 250 µg butrophanol.

To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine

and 0.5ml Normal saline.

To compare the duration of sensory block of intrathecal 0.5% levobupivacaine

with fentanyl vs butrophanol vs normal saline.

The present study will be conducted in the department of

Anaesthesiology, G.G.S. Medical College, Faridkot on 180 patients. The patient will

be divided into three groups of 60 each and the drug will be given as per group

allocation. The aims of the study is to compare the effects of both the drugs on time

and duration of sensory and motor block , maximum sensory level achieved, time to

regression of sensory block till S2 dermatome and time to regression of motor block.

The data will then be statistically analyzed.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender, aged between 18 and 65 years.
  • Patients of American Society of Anesthesiology Grade I and II physical status.
  • Patients scheduled for elective infraumbilical surgery under spinal anaesthesia.

排除标准

  • Patients with known allergy to any of the study drugs.
  • All known contraindications to spinal anaesthesia like: o Patients with coagulation disorders and on anticoagulants.
  • o Patients with local skin infection or disease.
  • o Patients with previous spinal surgeries, spine abnormalities.
  • Patient refusal.

结局指标

主要结局

To evaluate the duration of sensory and motor block

时间窗: with in 24hrs postoperatively

次要结局

  • Need for rescue analgesia(Till the effect of spinal analgesia subsides)

研究者

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

Dr Sarvjeet Kaur

Professor, Dept of Anaesthesia

研究点 (1)

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