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CTRI Number  CTRI/2025/11/097388 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A comparative study of post procedural pain relief of lignocaine spray and EMLA cream during knee injection with corticosteroid 
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A P NIRMAL  
Designation  SENIOR RESIDENT 
Affiliation  AIIMS BILASPUR 
Address  ROOM NO 722, PG BOYS B HOSTEL, AIIMS BILASPUR, HIMACHAL PRADESH

Bilaspur
HIMACHAL PRADESH
174001
India 
Phone  8015992664  
Fax    
Email  nirmalmay95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR YOGESH PREET SINGH 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS BILASPUR 
Address  FACULTY RESIDENCE, AIIMS BILASPUR, HIMACHAL PRADESH

Bilaspur
HIMACHAL PRADESH
174001
India 
Phone  9741592091  
Fax    
Email  yogeshmann@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR YOGESH PREET SINGH 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS BILASPUR 
Address  FACULTY RESIDENCE, AIIMS BILASPUR, HIMACHAL PRADESH

Bilaspur
HIMACHAL PRADESH
174001
India 
Phone  9741592091  
Fax    
Email  yogeshmann@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BILASPUR, HIMACHAL PRADESH India, Pincode- 174001 
 
Primary Sponsor  
Name  DR A P NIRMAL 
Address  ROOM NO 722, PG BOYS B HOSTEL, AIIMS BILASPUR, HIMACHAL PRADESH, INDIA, Pincode 174001 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR A P NIRMAL  AIIMS BILASPUR  Room NO 730, Rheumatology OPD and IPD, Department of Clinical Immunology and Rheumatology
Bilaspur
HIMACHAL PRADESH 
8015992664

nirmalmay95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EMLA Cream  2.5 grams cream, contact time of 1 hour 
Intervention  Lignocaine spray  10% spray, applied 3 times, contact time of 20 minutes 
Intervention  Nil  Nil 
Comparator Agent  No cream/no spray  no cream/no spray 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Diagnosed case of Rheumatoid Arthritis as per 2010 ACR/EULAR Classification Criteria
2. Having knee joint effusion and requires intra articular corticosteroid injection as per assessment of the treating physician.
 
 
ExclusionCriteria 
Details  1. Patients with suspicion of septic arthritis
2. History of adverse reactions to lidocaine
3. Superficial skin infection at the injection site
4. Patients with cognitive dysfunction or inability to assess pain scores associated with the procedure.
5. Pregnant and lactating females
6. Joint prosthesis, intra-articular fracture
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.   immediately after giving knee injection 
 
Secondary Outcome  
Outcome  TimePoints 
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.   
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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