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临床试验/CTRI/2024/11/076511
CTRI/2024/11/076511尚未招募2/3 期

Evaluate the Effect of Different Methods of Anxiolysis on Ultrasound Guided Brachial Plexus Block Success in Patients undergoing Upper Limb Surgery

Sri Guru Ram Das Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Rate of Block Faliure

研究概览

简要总结

Introduction: Preoperative anxiety is common and can affect surgical outcomes. The APAIS test is used to measure anxiety levels and need for information. Regional anesthesia, like brachial plexus block, is preferred for upper limb surgeries due to fewer side effects. However, anxiety can still affect patients, impacting block success. Ultrasound guidance improves outcomes but doesn’t eliminate block failure, prompting research into anxiety management’s impact on block success. Aims: The aim of the study is to assess the effect of various anxiety reduction methods on the success of ultrasound-guided brachial plexus block in upper limb surgery patients. Objective of the study is to investigate and compare the impact of counselling, and injection midazolam on ultrasound-guided brachial plexus block performance Methodology: Randomized controlled study will be conducted in 100 patients undergoing upper limb surgery under ultrasound guided brachial plexus block. Patients will be randomly divided into 2 groups of 50 each group A receiving preoperative counciling and group B receiving preoperative midazolam, patients will be evaluated for anxiety with HAM-A and APAIS in the preoperative area. Significance of the study: Explore various interventions to ease anxiety and enhance outcomes in ultrasound-guided brachial plexus block for upper limb surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 ASA grade I and II 2 Scheduled for elective upper limb extremity surgeries.

排除标准

  • 1 Patients having skin infection at the needle puncture site.
  • 2 Patients suffering from coagulopathies / bleeding disorders 3 Patients with history of neuropathies 4 Pregnant patients.
  • 5 Patients hypersensitive to the drugs being used in the study.
  • 6 Difficulty reading or understanding the anxiety form, mental illness, or psychiatric disease 7 Patients already on any sedative hypnotic’s medication.

结局指标

主要结局

Rate of Block Faliure

时间窗: from initiation of block to the end of surgery

次要结局

  • Sparing of Dermatome, postoperative analgesia requirement(initiation of block to 24 hour postoperative)

研究者

发起方
Sri Guru Ram Das Institute of Medical Sciences and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ruchi Gupta

Sri Guru Ram Das Institute of Medical Sciences and Research

研究点 (1)

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