| CTRI Number |
CTRI/2025/08/092845 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing which is better for pain relief during IV line insertion: lignocaine spray or EMLA cream in adults |
|
Scientific Title of Study
|
A comparative study on the efficacy, onset of action and safety of 10 percent lignocaine spray versus EMLA cream in reducing pain during IV cannulation – 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 |
Raja Mydeen |
| Designation |
Junior Resisdent |
| Affiliation |
SRM MCH and RC |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Institute of Science and Technology
SRM Nagar Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09176579572 |
| Fax |
|
| Email |
rajaej7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R. Jamuna Rani |
| Designation |
HOD |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Institute of Science and Technology
SRM Nagar Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840279010 |
| Fax |
|
| Email |
hod.phacol.ktr.med@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raja Mydeen |
| Designation |
Junior Resisdent |
| Affiliation |
SRM MCH and RC |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Institute of Science and Technology
SRM Nagar Kattankulathur
TAMIL NADU
603203
India |
| Phone |
09176579572 |
| Fax |
|
| Email |
rajaej7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Chengalpattu District, Tamil Nadu – 603203, India
|
|
|
Primary Sponsor
|
| Name |
Dr Raja Mydeen |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Institute of Science and Technology
SRM Nagar Kattankulathur |
| 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 Raja Mydeen |
SRM Medical College Hospital and Research Centre |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Institute of Science and Technology
SRM Nagar Kattankulathur
Kancheepuram
TAMIL NADU |
09176579572
rajaej7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pain induced by peripheral intravenous cannulation in upper limb veins of adult volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eutectic Mixture of Local Anesthetics (EMLA) Cream |
A pea-sized amount (1.5 g) of EMLA cream applied over peripheral upper limb vein 60 minutes before IV cannulation covered with occlusive dressing. |
| Intervention |
Lignocaine Spray |
10% Lignocaine spray - 2 puffs (approximately 20 mg) applied over peripheral upper limb vein 5 minutes before IV cannulation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 60 years
Either gender
Requiring IV cannulation as part of routine care
Intact skin over selected cannulation site on upper limb
Provided written informed consent |
|
| ExclusionCriteria |
| Details |
Known allergy to local anesthetics
History of methemoglobinemia or G6PD deficiency
Presence of diabetes mellitus, peripheral vascular disease, or Raynaud’s disease
Skin infection or ulceration at cannulation site
Patients who are critically ill or unconscious
Concurrent use of opioids or analgesics that interfere with pain assessment
Pediatric patients |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity assessed using Visual Analogue Scale (VAS) and Local Anesthetic Pain Assessment Questionnaire (LAPAQ) |
At 0 to 1 minute after IV cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to onset of local anesthesia (in minutes) |
At approximately 0 to 5 minutes after application of the drug, prior to IV cannulation |
| Duration of anesthetic effect |
Measured from onset of numbness until return of normal sensation assessed at fixed intervals of 15 minutes 30 minutes 45 minutes & 60 minutes after intravenous cannulation |
| Success rate of first-attempt IV cannulation |
At 0 minutes (immediately after first IV cannulation attempt) |
| Incidence of adverse effects |
At 15 minutes 30 minutes & 60 minutes after drug application |
| Patient satisfaction & perception of pain relief (using LAPAQ) |
At 1 to 2 minutes after IV cannulation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2025 |
| Date of Study Completion (India) |
28/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajaej7@gmail.com].
- For how long will this data be available start date provided 02-04-2026 and end date provided 02-03-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to compare the efficacy, onset of action, and safety of 10% lignocaine spray versus EMLA cream in reducing pain associated with peripheral intravenous (IV) cannulation in adult patients. The primary hypothesis is that lignocaine spray provides comparable or superior analgesia with a faster onset than EMLA cream. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and the Local Anesthetic Pain Assessment Questionnaire (LAPAQ), a structured tool designed to evaluate the patient’s perception of pain relief, comfort, and satisfaction following local anesthetic application. Secondary outcomes include onset time, duration of anesthesia, success of first-attempt cannulation, adverse events, and patient satisfaction.
Note: Initial data from the first 30 participants may be analyzed and published as preliminary (pilot) findings to inform the full-scale study |