| CTRI Number |
CTRI/2024/05/067452 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of 10% Lignocaine spray and cryoanalgesia (ice bag) in relieving venepuncture pain in adult patients |
|
Scientific Title of Study
|
A comparative study of 10% lignocaine spray versus cryoanalgesia (ice bag)in relieving pain of venipuncture 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 Palash Roy |
| Designation |
Post graduate trainee Anaesthesiology |
| Affiliation |
Institute of Postgraduate Medical Education and Research, Kolkata |
| Address |
Institute of Postgraduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9232123140 |
| Fax |
|
| Email |
roy.palash25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Institute of Postgraduate Medical Education and Research, Kolkata |
| Address |
Institute of Postgraduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Institute of Postgraduate Medical Education and Research, Kolkata |
| Address |
Institute of Postgraduate Medical Education and Research
Department of Anaesthesiology, 244 AJC Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Institute of Post Graduate Medical Education and Research, kolkata
244 AJC Bose Road, Kolkata
Pin:700020
west Bengal
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology
Institute of Post Graduate Medical Education and Research, 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 Palash Roy |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Anaesthesiology, 3rd floor, Main Block, 244 AJC Bose Road, Kolkata - 700020 Kolkata WEST BENGAL
Kolkata
WEST BENGAL |
9232123140
roy.palash25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&RResearch Oversight Committee |
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 |
| Intervention |
Application of 10% lignocaine spray prior to venepuncture |
Application of 10% lignocaine spray 6 times over the intended site from a distance of 5cm prior to venepuncture in adult patients posted for elective surgery. |
| Comparator Agent |
Application of cryoanalgesia (ice bag) prior to venepuncture |
Application of cryoanalgesia (ice bag) in the form of nontoxic silica gel that had been kept in a freezer for 3 hours prior to venepuncture in adult patients posted for elective surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients requiring peripheral venous cannulation prior to surgery
Age between 20-60 years
ASA-PS I and II
Able to understand and report pain according to visual analogue scale (VAS) |
|
| ExclusionCriteria |
| Details |
Patients unable to communicate verbally.
Lignocaine allergy
Patient already receiving analgesic medications within last 24 hours
Patients with needle phobia
Extreme anxiety
Unhealthy skin condition at proposed site of venepuncture
Patients in whom more than one attempt will be required for venepuncture |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of 10% lignocaine spray over cryoanalgesia (ice bag)in relieving pain of venepuncture in adult patients |
While performing venepuncture |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of VAS score between 10% lignocaine spray versus cryoanalgesia (ice bag) while performing venepuncture in adult patients |
While performing venepuncture |
| Comparison of haemodynamic profile between 10% lignocaine spray versus cryoanalgesia (ice bag) while performing venepuncture in adult patients |
While performing venepuncture |
| Comparison of incidence of wrist movements between 10% lignocaine spray versus cryoanalgesia (ice bag) while performing venepuncture in adult patients |
While performing venepuncture |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="162" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/08/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Peripheral venous cannulation is often painful even in adult patients. Various pharmacological as well as non pharmacological measures have employed to make venepuncture painless. This study will compare the efficacy of 10% lignocaine spray versus cryoanalgesia (ice bag)in relieving pain of venepuncture in adult patients. |