| CTRI Number |
CTRI/2024/04/065130 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A copmparison of result of pain reducing capability of 10% lignocaine spray versus ice pack in artery puncture of wrist in adult patients |
|
Scientific Title of Study
|
A comparative study of 10% lignocaine spray versus cryoanalgesia (ice pack) in relieving pain of radial arterial puncture in awake 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 Sandip Bose |
| Designation |
PG student |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Department of Anaesthesiology, IPGMER and SSKM Hospital, 244, A.J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8910342841 |
| Fax |
|
| Email |
sandipbose1510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Department of Anaesthesiology, IPGMER and SSKM Hospital, 244, A.J.C. Bose road, Kolkata 700020
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 Post Graduate Medical Education and Research |
| Address |
Department of Anaesthesiology, IPGMER and SSKM Hospital, 244, A.J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, IPGMER and SSKM Hospital,244, A.J.C. Bose road,Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, IPGMER and SSKM Hospital |
| Address |
Department of Anaesthesiology,IPGMER and SSKM Hospital,244,A.J.C.Bose road,Kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Chiranjib Bhattacharyya |
IPGMER and SSKM Hospital. 244, A.J.C. Bose road,Kolkata 700020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandip Bose |
IPGMER and SSKM Hospital,Kolkata |
Main OT complex ,Urology OT,ENT OT, NPS OT, 244 , A.J.C. Bose road,Kolkata 700020
Kolkata
WEST BENGAL |
8910342841
sandipbose1510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research 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 |
10% Lignocaine spray |
The analgesic efficacy of 10% Lignocaine spray in relieving pain of radial artery cannulation in awake adult patients prior to elective surgery.10% lignocaine will be sprayed six times over the puncture site from a distance of 5 cm.After waiting for 5 min, radial artery puncture will be attemted. |
| Comparator Agent |
Ice pack |
Compare the analgesic efficacy of 10% Lignocaine spray with ice pack ( cryoanalgesia) in relieving pain of radial artery cannulation in awake adult patients prior to elective surgery.Ice pack will be applied to puncture site for 3 min before attempting cannulation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Awake adult patients requiring radial artery cannulation prior to elective surgery 2. Age between 20 - 60 years 3. ASA physical status 1 and 2. 4.Able to understand and report pain according to VAS |
|
| ExclusionCriteria |
| Details |
1.Unable to communicate verbally 2.Lignocaine allergy 3.Patients receiving analgesic medication or sedatives within last 24 hours 4.Abnormal Allen’s test 5.Raynaud’s disease 6.Patients with needle phobia,extreme anxiety 7.Requiring more than one attempt to access the artery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of pain scores in patients receiving either 10% Lignocaine spray or ice pack (cryoanalgesia) before radial artery cannulation |
Immediately after arterial puncture and 5 min later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Haemodynamic changes 2.First attempt success rate 3.wrist movement |
Immediately after arterial puncture and 5 min later |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/04/2024 |
| Date of Study Completion (India) |
24/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The analgesic efficacy of 10% lignocaine spray has not been compared with cryoanalgesia ( ice pack) in radial artery puncture.The study is relevant because it intends to address this unexplored issue.It is expected that application of 10% lignocaine spray will be as effective in providing dermal analgesia for radial artery puncture in comparison to cryoanalgesia in awake adult patients. |