| CTRI Number |
CTRI/2018/11/016298 [Registered on: 09/11/2018] Trial Registered Prospectively |
| Last Modified On: |
06/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
use of skin numbing very small size injections to reduce bigger injection pain before surgery |
|
Scientific Title of Study
|
Use of subcutaneous infiltration with insulin syringe to decrease intravenous cannulation stress response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
pankaj v patel |
| Designation |
anesthesiologist |
| Affiliation |
muljibhai patel urological hospital, nadiad |
| Address |
Muljibhai Patel Urological Hospital, Department of Anesthesia,OT complex, Ground floor, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8128600624 |
| Fax |
|
| Email |
pankajpatel_81@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
pankaj v patel |
| Designation |
anesthesiologist |
| Affiliation |
muljibhai patel urological hospital, nadiad |
| Address |
Muljibhai patel Urological Hospital, OT complex, Department of Anesthesia, Ground floor, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8128600624 |
| Fax |
|
| Email |
pankajpatel_81@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
pankaj v patel |
| Designation |
anesthesiologist |
| Affiliation |
muljibhai patel urological hospital, nadiad |
| Address |
Muljibhai Patel Urological Hospital, Department of Anesthesia, OT complex, Ground Floor, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8128600624 |
| Fax |
|
| Email |
pankajpatel_81@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| muljibhai patel urological hospital, Department Of Anesthesia,OT complex, nadiad 387001 |
|
|
Primary Sponsor
|
| Name |
muljibhai patel urological hospital |
| Address |
virendra desai road, nadiad 387001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 pankaj patel |
muljibhai patel urological hospital |
Department of anesthesia , OT complex , ground floor
Kheda
GUJARAT |
8128600624
pankajpatel_81@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MPSRNUEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lignocaine 2% |
infiltration of skin with lignocaine 2% using insulin syringe |
| Comparator Agent |
normal saline |
infiltration of skin using normal saline with insulin syringe |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
12 YEARS TILL 50 YEARS OF AGE |
|
| ExclusionCriteria |
| Details |
Localized infection at proposed site of injection,Patients below 12 and above 50 years of age, Patients requiring cannulation other than 18 guage intravenous cannula
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our primary aim is to study pain effect of the patients after subcutaneous xylocaine infitration with insulin syringe before intravenous cannulation .secondary outcome will be to study patient satisfaction scores with help of likert scale |
pain score with the help of VAS score and satisfaction score with the help of likert scale immediately after injection and before start of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overal satisfaction scores of patients using likerts scale |
after local anesthetic injection before start of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
EC/541/2018 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intravenous cannulation is a mandatory process before start of every surgery whether it may be a general or regional anesthesia. The size of cannula may vary from smaller ones like 22guage to bigger ones like 16 guage , depending on type and complexity of the surgery . Guidelines recommend that for monitored anesthesia care a secured iv cannula is a must. Even a simple needle prick to the patient might invoke stress response and significant amount of phobia in him before the start of the procedure. Also it may lead to dreaded compilcations like vaso vagal attack leading to bradycardia and arrest. To decrease this intravenous cannulation stress response, we infiltrated the propsed iv site with 0.5ml of subcutaneous xylocaine with a insulin syringe in 50 patients (study group), whereas the control group included 50 patients with saline infiltration . |