| CTRI Number |
CTRI/2026/03/105960 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Lidocaine patch and EMLA cream in reducing pain during epidural injection in adult patients undergoing surgery |
|
Scientific Title of Study
|
A STUDY ON THE EFFECTIVENESS OF LIDOCAINE PATCH VERSUS EUTECTIC MIXTURE OF LOCAL ANAESTHETICS (EMLA) CREAM IN PREVENTING PAIN DURING EPIDURAL NEEDLE INSERTION: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetan Jain Dilip |
| Designation |
Post Graduate |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL PUDUCHERRY |
| Address |
Department of Anaesthesiology
Aarupadai Veedu Medical College and Hospital
Pondy Cuddalore Main Road
Kirumampakkam
Puducherry 607403
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
09491455641 |
| Fax |
|
| Email |
chetanjain308@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Prabhu C |
| Designation |
Professor |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology
Aarupadai Veedu Medical College and Hospital
Pondy Cuddalore Main Road
Kirumampakkam
Puducherry 607403
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843360106 |
| Fax |
|
| Email |
cr.prabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gauthamabuddha P |
| Designation |
Assistant Professor |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL Pondicherry |
| Address |
Department of Anaesthesiology
Aarupadai Veedu Medical College and Hospital
Pondy Cuddalore Main Road
Kirumampakkam
Puducherry 607403
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9786610917 |
| Fax |
|
| Email |
gautampranava@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chetan Jain Dilip |
| Address |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL Pondicherry |
| Type of Sponsor |
Other [Self funded] |
|
|
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 C Rajesh Prabhu |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology
Aarupadai Veedu Medical College and Hospital
Pondy Cuddalore Main Road
Kirumampakkam
Puducherry 607403
India
Pondicherry
PONDICHERRY |
9843360106
cr.prabhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Aarupadai Veedu Medical College and Hospital Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EMLA Cream |
Eutectic Mixture of Local Anaesthetics (2.5% Lidocaine + 2.5% Prilocaine) applied at the appropriate vertebral level 30 minutes prior to surgery with occlusive dressing. Cream removed in pre-operative room before shifting to OT. |
| Intervention |
Lidocaine Patch |
Transdermal Lidocaine Patch applied approximately 10 hours prior to surgery at the appropriate vertebral level. Patch removed in pre-operative room before shifting to OT to avoid observer bias. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II, III
Patients undergoing Lower abdominal / Pelvic / Lower limb surgeries requiring Epidural Anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in the study
Known allergy to local anaesthetics
Contraindication to epidural anaesthesia
Patients requiring rescue analgesia with 2% lignocaine infiltration during epidural needle insertion |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic efficacy assessed using 10-point Visual Analogue Scale (VAS) |
Within five minutes after epidural needle insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective assessment of pain using Wong Baker Scale |
At the time of epidural needle insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to compare the effectiveness of Lidocaine patch versus EMLA cream in preventing pain during epidural needle insertion. Epidural needle insertion using a 16G Tuohy needle is often associated with discomfort and pain. Topical anaesthetic agents may help reduce this pain and improve patient comfort. This is a single blinded randomized controlled trial conducted in the Department of Anaesthesiology at Aarupadai Veedu Medical College and Hospital Puducherry. Eighty patients aged 18 to 65 years belonging to ASA I II and III undergoing elective lower abdominal pelvic or lower limb surgeries requiring epidural anaesthesia will be included. Participants will be randomized using block randomization into two groups of forty each. Group A will receive transdermal Lidocaine patch approximately ten hours before surgery. Group B will receive EMLA cream applied thirty minutes before surgery with occlusive dressing. The primary outcome will be analgesic efficacy assessed using ten point Visual Analogue Scale immediately after epidural needle insertion. The secondary outcome will be subjective pain assessment using Wong Baker Scale at the time of needle insertion. The results of this study will help determine whether Lidocaine patch can be used as an effective alternative to EMLA cream in reducing pain during epidural needle insertion. |