| CTRI Number |
CTRI/2026/01/101474 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two local anesthetic skin treatments to reduce pain during IV cannulation in patients undergoing planned surgery. |
|
Scientific Title of Study
|
A comparative study of the effectiveness of lidocaine patch and EMLA cream on peripheral intravenous cannulation pain in patients posted for elective surgeries. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Kumar Yadav |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College,NH-58,Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Department of Anaesthesiology & Critical Care, Subharti Medical College,NH-58,Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7705969160 |
| Fax |
|
| Email |
ypradeepkumar922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brig HS Minhas |
| Designation |
Professor |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College,NH-58,Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9950797341 |
| Fax |
|
| Email |
hsminhas28@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brig HS Minhas |
| Designation |
Professor |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology & Critical Care, Subharti Medical College,NH-58,Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9950797341 |
| Fax |
|
| Email |
hsminhas28@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, Meerut, Uttar Pradesh, 250005 (India) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Pradeep Kumar Yadav |
Chhatrapati Shivaji Subharti Hospital |
Chhatrapati Shivaji Subharti Hospital, Subharti Medical College, NH-58, Delhi-Haridwar Bypass Road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
7705969160
ypradeepkumar922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
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 |
Prilocaine 2.5% and 2.5% Lidocaine.
EMLA cream will be applied 30 minutes before peripheral iv cannulation. |
| Intervention |
Lidocaine patch 5% |
Patch will be applied 30 minutes before peripheral iv cannulation. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 12 to 60 years.
2. Both male and female patients.
3. Patients scheduled for elective surgeries requiring iv cannulation.
|
|
| ExclusionCriteria |
| Details |
1. History of any cardiac disease (arrhythmia), vascualr disease.
2. Presence of local skin infection.
3. Use of analgesics within 24 hours prior to cannulation.
Known allergy or sensitivity to amide local anaesthetic or glycerine.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the pain score during peripheral intravenous cannulation, measured using a Visual Analog Scale (VAS) of 0-10 |
Immediately & 1 minute after cannulation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hemodynamic parameters during intravenous cannulation, Incidence and severity of local skin reactions following application of lidocaine patch or EMLA cream. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
30/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a prospective, randomized comparative study which compares the effectiveness of lidocaine patch and EMLA cream on peripheral intravenous cannulation pain in patients posted for elective surgeries. The primary objective is to compare the effectiveness of EMLA cream versus lidocaine patch. The secondary objective is to observe any hemodynamic changes during iv cannulation and to assess any local skin reaction to EMLA cream or lidocaine patch. |