| CTRI Number |
CTRI/2025/02/080233 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between lignociane pretreatment and lignociane mixed with propofol for propofol induced pain |
|
Scientific Title of Study
|
Effectiveness of lignocaine pretreatment vs lignocaine mixed with propofol in preventing pain due to propofol injection : a randomised control study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumanth S |
| Designation |
Junior resident 3rd year , department of anesthesiology |
| Affiliation |
ESIC PGIMSR |
| Address |
Room no 205,1st floor,esi pg hostel,ESIC PGIMSR Rajajinagar,Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
919538839421 |
| Fax |
|
| Email |
sumanthsholla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Das |
| Designation |
Associate Professor, department of anesthesiology |
| Affiliation |
ESIC PGIMSR |
| Address |
Room number 2,Second floor ot complex ,ESIC PGIMSR Rajajinagar,Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
988337885 |
| Fax |
|
| Email |
drashok782@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Das |
| Designation |
Associate Professor, department of anesthesiology |
| Affiliation |
ESIC PGIMSR |
| Address |
Room number 2,Second floor ot complex,ESIC PGIMSR Rajajinagar,Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
988337885 |
| Fax |
|
| Email |
drashok782@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI medical college And PGIMSR Rajajinagar
Bangalore 560010
Karnataka
India
|
|
|
Primary Sponsor
|
| Name |
Dr SUMANTH S |
| Address |
ESIC And PGIMSR Rajajinagar Bangalore 560010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sumanth S |
ESI medical college and PGIMSR |
Room number 2, Second floor ot complex,dept of anesthesiology, ESI medical college And PGIMSR Rajajinagar Bangalore 560010
Bangalore
KARNATAKA |
9538839421
sumanthsholla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
comparison between lignocaine pretreatment and lignocaine mixed with propofol |
lignocaine pretreatment 20mg followed by tourniquet at 50mmhg after which 50percent of propofol is given and pain is assessed |
| Comparator Agent |
comparison between lignocaine pretreatment with lignocaine mixed with propofol |
Normal saline 2ml followed by tourniquet at 50mmhg followed by lignocaine 20mg mixed with propofol is given and pain is assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients willing to give informed consent and belong to ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
patient not willing to give informed written consent
patient with risk factors for difficult airway
patient with known pulmonary and cardiovascular diseases
known allergy to local anesthetic,propofol
obese patients
patients who are mentally unstable,visually impaired
patient with difficult intravenous access or with less than 20g cannula in situ |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the frequency of pain reported by the patient during injection using numerical pain rating scale |
Pain score during injection of propofol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the frequency of pain reported by the patient just before shifting out the patient from recovery using numerical pain rating scale |
pain just before shifting out the patient from recovery |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (sumanthsholla@gmail.com).
- For how long will this data be available start date provided 10-11-2024 and end date provided 13-10-2039?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Comparison between effectiveness of lignocaine pretreatment and lignocaine mixed with propofol in preventing pain due to propofol injection as propofol on injection causes pain and there are various methods to relieve this pain . so we want to compare to such methods to decrease the pain due to propofol injection in an actual daily routine practice after premedicating the patients while the previous studies are done without premedication |