| CTRI Number |
CTRI/2026/02/104953 [Registered on: 26/02/2026] 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
|
Comparison Between Lignocaine Patch And Diclofenac Patch for relief of Venepuncture Pain In Adult Patients |
|
Scientific Title of Study
|
Comparison Between Lignocaine Patch And Diclofenac Patch On Venepuncture Pain In Adult Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARPANA KUMARI |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology, 244 AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL
700020
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903990230 |
| Fax |
|
| Email |
arpanathakur1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Medical Education and Research,kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology,244 AJC Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHANCHANDRA MANDAL |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Medical Education and Research,kolkata |
| Address |
Institute of Post Graduate Medical Education and Research, Department of Anaesthesiology,244 AJC Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Institute of Post Graduate Medical Education and Research and sskmhospital,244 Ajc bose road Kolkata- 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
3rd floor, main OT complex, main block, Institute of Post Graduate Medical Education and Research and SSKM HOSPITAL,244 AJC Bose Road, Kolkata- 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 arpana kumari |
institute of post graduate medical education and research, kolkata |
department of anaesthesiology, institute of medical education and research, 244 AJC Bose road, kolata
Kolkata
WEST BENGAL |
9903990230
arpanathakur1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac patch |
Application of diclofenac patch(100mg) 60 mins prior to venous cannulation |
| Intervention |
Lignocaine patch |
Lignocaine patch application 60 mins prior to venous cannulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
adult patients aged 18-65 years, of ASA class 1-3, undergoing elective surgery in general surgery and allied surgeries requiring intravenous cannula insertion for their anaesthesia care. |
|
| ExclusionCriteria |
| Details |
1.inability to consent
2. known coagulopathy
3.mental retardation or inability to understand VAS or 4-point visual analogue scale
4. history of allergy to drugs
5. patients with skin conditions, infections or dermatological disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the pain scores between the two groups assessed just after venous cannulation using visual analogue scale |
At the time of cannula insertion using Visual Analogue Scale which is explained to patient beforehand |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess & compare the pain on injecting propofol between the two groups on a four point verbal scale |
At the time of induction of general anaesthesia after intermittently injecting 2ml or 20mg propofol |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2026 |
| 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="1"
Months="2"
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
|
Insertion of venous cannula is a routine procedure in operating room that is often performed without any anaesthesia. Pain on insertion of venous cannula can be considered as t5he first negative experience related with hospital care and this can instill a sense ofr mistrust among patients regarding the empathy of care provider. existing literature suggests both lignocaine patch and diclofenac patch have not been compared in a single study to examine the effects of these pharmacological agents in attenuating the pain of venous cannula insertion. |