| 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
|
|
|
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
|
|
|
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. |