| CTRI Number |
CTRI/2024/05/066762 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Is 2% lidocaine spray administration prior to respiratory procedure effective in reducing pain of lidocaine local anaesthesia? |
|
Scientific Title of Study
|
Randomized controlled trial to look into effect of topical 2% lidocaine spray in reducing pain prior to intradermal lidocaine for local anaesthesia in patients undergoing respiratory procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sobankumar |
| Designation |
Junior resident-1st year Post graduate |
| Affiliation |
Christian medical college and hospital |
| Address |
Department of Respiratory medicine.
Christian medical college and hospital
vellore
Vellore
TAMIL NADU
621001
India |
| Phone |
9159199577 |
| Fax |
|
| Email |
kumarsoban60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Gupta |
| Designation |
Professor and head of department |
| Affiliation |
Christian medical college and hospital |
| Address |
Department of Respiratory medicine.
Christian medical college and hospital
vellore
Vellore
TAMIL NADU
621001
India |
| Phone |
9600771705 |
| Fax |
|
| Email |
drricha21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sobankumar |
| Designation |
Junior resident-1st year Post graduate |
| Affiliation |
Christian medical college and hospital |
| Address |
Department of Respiratory medicine.
Christian medical college and hospital
vellore
Vellore
TAMIL NADU
621001
India |
| Phone |
9159199577 |
| Fax |
|
| Email |
kumarsoban60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian medical college ,Vellore |
|
|
Primary Sponsor
|
| Name |
Christian medical college |
| Address |
Christian medical college and hospital
vellore |
| Type of Sponsor |
Private 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 Sobankumar |
Christian medical college ,Vellore |
Department of respiratory medicine
Bronhcoscopy and USG room
Respiratory medicine ward
Vellore
TAMIL NADU |
9159199577
kumarsoban60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian medical college ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Lignocaine |
2 % topical lignocaine used as spray prior to intradermal lignocaine anaesthesia |
| Comparator Agent |
normal saline |
0.9 % Normal saline used as spray |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive patients undergoing respiratory diagnostic and therapeutic procedures requiring administration of intradermal ligniocaine injection and Image guided diagnostic and therapeutic pleurocentesis ,Chest drain insertion, medical Image guided closed pleural biopsy thoracoscopy during study period will be considered eligible for inclusion if they are
1.Aged above 18 years
2.Hemodynamically stable
|
|
| ExclusionCriteria |
| Details |
1.No consent
2.Documented history of lignocaine toxicity
3.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pain scores during intradermal lidocaine infiltration between two study groups i.e. 2%lidocaine spray vs Normal saline spray by using FACES score. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the percentage of proportion of patients in each arm who required 2nd or more additional dose of local anesthesia to complete the procedure
2.To determine pain related adverse events(vasovagal syncope ) |
baseline |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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)
|
15/05/2024 |
| 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="1"
Months="0"
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
|
The aim of this study is to assess whether there is a reduction in pain perception in patients while receiving an additional skin surface lidocaine spray just prior to intradermal lignocaine infiltration in patients undergoing respiratory procedures. Patients will be randomized into two arms (2% lidocaine spray arm and Normal saline spray arm). Pain perception in each arm following the intradermal lidocaine infiltration will be assessed with FACES pain score. Additionally, we will look into incidence of pain related adverse events like vasovagal syncope in both study groups. For this randomized controlled trial, patients will be recruited from outpatients and in patients under respiratory medicine department. Study will be conducted in bronchoscopy suite /respiratory medicine treatment room /respiratory medicine ward of CMC Vellore. It will be conducted as an Placebo controlled randomized controlled study. The main primary outcome is patient Score rated by FACES pain scale. |