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临床试验/CTRI/2025/11/097388
CTRI/2025/11/097388招募中不适用

A Comparative Study of the anaesthetic effect of 10 percentage Lignocaine Spray and Eutectic Mixture Of 2.5 percentage Lidocaine and 2.5 percentage Prilocaine (EMLA) Cream During Intra-Articular Corticosteroid Injection of the Knee Joint in patients with Rheumatoid Arthritis

DR A P NIRMAL1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
To compare the immediate post-procedural anaesthetic effect of 10% lignocaine spray and EMLA cream in facilitating analgesia during the intraarticular corticosteroid injection in a single knee joint.

研究概览

简要总结

The rationale for this study stems from the need to optimize pain management during IACI in Knee joint effusion in patients with Rheumatoid Arthritis. While IACI is a widely used and effective treatment for reducing joint inflammation and providing symptom relief in conditions such as rheumatoid arthritis and osteoarthritis, the procedure can cause significant pain, potentially limiting patient compliance and willingness to undergo repeated injections. Effective pain control is, therefore, essential for improving patient experience and ensuring the success of these therapeutic interventions. Both 10% xylocaine spray and EMLA cream are commonly used topical anaesthetics for a variety of procedures. However, there is limited data comparing their efficacy specifically in the context of IACI, especially in adult patients with inflammatory arthritis. This study aims to compare the anaesthetic effectiveness between these two widely used topical anaesthetic agents during IACI. The findings of this study will help clinicians select the most appropriate topical anaesthetic, thereby improving patient comfort, reducing procedural pain, and enhancing overall treatment adherence for patients with Rheumatoid arthritis undergoing IACI. By providing comparative data, this study will address the current gap in knowledge regarding optimal pain management strategies for IACI in this patient population.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed case of Rheumatoid Arthritis as per 2010 ACR/EULAR Classification Criteria
  • Having knee joint effusion and requires intra articular corticosteroid injection as per assessment of the treating physician.

排除标准

  • Patients with suspicion of septic arthritis
  • History of adverse reactions to lidocaine
  • Superficial skin infection at the injection site
  • Patients with cognitive dysfunction or inability to assess pain scores associated with the procedure.
  • Pregnant and lactating females
  • Joint prosthesis, intra-articular fracture.

结局指标

主要结局

To compare the immediate post-procedural anaesthetic effect of 10% lignocaine spray and EMLA cream in facilitating analgesia during the intraarticular corticosteroid injection in a single knee joint.

时间窗: immediately after giving knee injection

次要结局

  • To compare anaesthetic effect of 10% Lignocaine spray and EMLA cream at 1 hour & 24 hour after procedure(At 1 hour and 24 hours after procedure)
  • To compare the change in baseline pain scores immediately after IACI.

研究者

发起方
DR A P NIRMAL
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

A P NIRMAL

AIIMS BILASPUR

研究点 (1)

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