| CTRI Number |
CTRI/2024/02/062548 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Local anaesthetic for pain relief ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of the effectiveness of a two different local anaesthetic drug 10% lignocaine spray and EMLA cream in reducing pain during IV cannulation. |
|
Scientific Title of Study
|
A comparison of 10% lignocaine spray versus eutectic mixture
of 2.5% lidocaine and 2.5% prilocaine (EMLA) to attenuate
pain of peripheral venous cannulation in adults: A
prospective randomised single-blind placebo-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 |
Mona K |
| Designation |
Post graduate |
| Affiliation |
Mahatma Gandhi Medical college and Research Institute |
| Address |
Department of Anaesthesiology, second floor, hospital block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7708846266 |
| Fax |
|
| Email |
monakkraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Mishra |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology, second floor, hospital block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Mishra |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology, second floor, hospital block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894354068 |
| Fax |
|
| Email |
drgayatrimishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Mona K |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology and Pain Medicine, SBV Main campus, Pillaiyarkuppam
Pondicherry
PONDICHERRY |
7708846266
monakkraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% Lignocaine spray |
10% Lignocaine spray will be applied at the proposed site of IV cannulation 20 minutes prior to cannulation. Pain will be assessed by VAS score.
VAS score will be assessed immediately after cannulation and 10 mins later. |
| Comparator Agent |
EMLA cream (2.5% Lidocaine and 2.5% Prilocaine) |
EMLA cream (2.5% Lidocaine and 2.5% Prilocaine) will be applied at the proposed site of IV cannulation 60 minutes prior to cannulation. Pain will be assessed by VAS score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiology (ASA I to IV) |
|
| ExclusionCriteria |
| Details |
Refusal to participate
Difficult iv cannulations
Any burns, ulceration, erythema and infected skin · Any allergic to amide local anaesthetic
History of deep vein thrombosis or any other vascular disorder · History of cardiac disease or migraine headachesPregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess and compare degree of severity of pain during IV cannulation using the
visual analogue scale (VAS) pain score
|
Immediately after cannulation and 10 mins later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe any change in hemodynamics – BP, HR, SPO2 after topical application
of study drugs.
To assess and compare the ease of cannulation
To assess and compare the incidence of adverse effects if any in both the groups |
Upto 30 mins post cannulation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Baseline vitals will be taken after group allocation, and one group will get 10% lignocaine spray while the other group will receive emla cream. The VAS score will be assessed in both the study groups for measuring pain immediately after cannulation and 10 mins later. Additionally hemodynamic parameters and grading of ease of cannulation will also be noted The study aims to compare the efficacy of 10% lignocaine spray and EMLA cream in reducing pain associated with peripheral venous cannulation |