| CTRI Number |
CTRI/2019/11/022131 [Registered on: 25/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| 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 EFFECT OF TWO DRUGS LIGNOCAINE AND PRILOCAINE AND LIGNOCAINE AND TETRACAINE WHICH CAUSES ANAESTHESIA OVER SKIN |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF A MIXTURE OF LIGNOCAINE AND TETRACAINE CREAM AND A MIXTURE OF LIGNOCAINE AND PRILOCAINE CREAM FOR PAIN RELIEF DURING VENEPUNCTURE IN ADULT PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHANAL ALIMA |
| Designation |
POST GRADUATE TRAINEE IN MD ANAESTHESIOLOGY |
| Affiliation |
KPC MEDICAL COLLEGE HOSPITAL |
| Address |
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA 700032
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
Kolkata
WEST BENGAL
700032
India |
| Phone |
9844109041 |
| Fax |
|
| Email |
shanalalima12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMAPATI SANYAL |
| Designation |
ASSOCIATE PROFESSOR IN ANAESTHESIOLOGY |
| Affiliation |
KPC MEDICAL COLLEGE HOSPITAL |
| Address |
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA 700032
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830163182 |
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHANAL ALIMA |
| Designation |
POST GRADUATE TRAINEE IN MD ANAESTHESIOLOGY |
| Affiliation |
KPC MEDICAL COLLEGE HOSPITAL |
| Address |
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA 700032
DEPT OF ANAESTHESIA ROOM NO 225
KPC MEDICAL COLLEGE HOSPITAL
Kolkata
WEST BENGAL
700032
India |
| Phone |
9844109041 |
| Fax |
|
| Email |
shanalalima12@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC MEDICAL COLLEGE HOSPITAL
1 F SC RAJA MULLICK ROAD JADAVPUR 700032 |
|
|
Primary Sponsor
|
| Name |
KPC MEDICAL COLLEGE |
| Address |
1F RAJA S C MULLICK ROAD JADAVPUR KOLKATA 700032 |
| 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 |
| SHANAL ALIMA |
KPC MEDICAL COLLEGE |
1F RAJA S C MULLICK ROAD JADAVPUR DEPT OF ANAESTHESIA
Kolkata
WEST BENGAL |
9844109041
shanalalima12@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 |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LIGNOCAINE 2.5% AND PRILOCAINE 2.5 % CREAM AND LIGNOCAINE 7% AND TETRACAINE 7% CREAM |
APPLICATION OF THESE CREAMS BEFORE VENEPUNCTURE |
| Comparator Agent |
SURFACE COMPARISON OF EUTECTIC MIXTURE OF LIGNOCAINE 2.5% AND PRILOCAINE 2.5% AND LIGNOCAINE 7% AND TETRACAINE 7% BEFORE VENEPUNCTURE |
APPLICATION OF MIXTURE OF 2.5 % LIGNOCAINE AND 2.5% PRILOCAINE CREAM AND7% LIGNOCAINE AND 7% TETRACAINE CREAM ON INTACT SKIN 1 HOUR BEFORE VENEPUNCTURE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II |
|
| ExclusionCriteria |
| Details |
ALLERGY TO AMIDE LOCAL ANAESTHETICS USE OF MONOAMINE OXIDASE INHIBITORS OR TCA RASH OR IMPAIRED SKIN INTEGRITY INTRAVENOUS CANNULATION REQUIRING MORE THAN ONE ATTEMPT CONGENITAL OR IDIOPATHIC METHEMOGLOBINEMIA PREGNANT OR BREAST FEEDING PATIENTS CHILDREN AND NEONATES |
|
|
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 |
| VISUAL ANALOGUE SCORE |
AFTER IV CANNULATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CARDIOVASCULAR CHANGES ARE ALSO NOTED UPTO 30 MINUTES |
JUST BEFORE VENEPUNCTURE 1 MINUTE 5 MINUTES 10 MINUTES 15 MINUTES 20 MINUTES 25 AND 30 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/12/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A CLINICAL TRIAL WILL BE CONDUCTED TO COMPARE TWO EUTECTIC MIXTURES LIGNOCAINE & PRILOCAINE AND LIGNOCAINE & TETRACAINE CREAM BEFORE VENEPUNCTURE BY APPLYING IT FOR 1 HOUR PRIOR AND THEN THE VISUAL ANALOGUE SCORE AND HEMODYNAMIC MONITORS OF THE PATIENT WILL BE RECORDED BEFORE VENEPUNCTURE AND AFTER 1 MINUTE 5 MINUTE 10 MINUTE 15 MINUTES 20 MINUTES 25 MINUTES AND 30 MINUTES AFTER VENEPUNCTURE |