| CTRI Number |
CTRI/2021/10/037062 [Registered on: 04/10/2021] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison between two procedures using a drug, ropivacaine for postoperative pain relief in children undergoing circumcision. |
|
Scientific Title of Study
|
A STUDY COMPARING CAUDAL BLOCK AND PENILE BLOCK USING ROPIVACAINE FOR POST OPERATIVE ANALGESIA IN PEDIATRIC PATIENT POSTED FOR CIRCUMCISION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Chitranshi |
| Designation |
Lecturer, Department of Anesthesiology |
| Affiliation |
Department of Anesthesiology,Dr. D.Y Patil Medical college, hospital and research institute |
| Address |
Department of Anesthesiology, Old opd building, Ground floor
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018, maharashtra
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9936036298 |
| Fax |
|
| Email |
drshwetachitranshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Jayakar |
| Designation |
Associate Professor, Department of Anesthesiology |
| Affiliation |
Department of Anesthesiology, Dr. D.Y Patil Medical college, hospital and research institute |
| Address |
Department of Anesthesiology, Old opd building, ground floor.
D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018, maharashtra
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7756850492 |
| Fax |
|
| Email |
sheetaljayakar2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Chitranshi |
| Designation |
Lecturer, Department of Anesthesiology |
| Affiliation |
Department of Anesthesiology, Dr. D.Y Patil Medical college, hospital and research institute |
| Address |
Department of Anesthesiology, Old opd building, ground floor
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018, maharashtra
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9936036298 |
| Fax |
|
| Email |
drshwetachitranshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil medical college, hospital & research centre, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
dr shweta chitranshi |
| Address |
Dr. D.Y Patil Medical college, hospital and research institute, sant tukaram road, pimpri, pune - 411018 |
| 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 Shweta Chitranshi |
Department of Anesthesiology, Dr. D.Y Patil Medical college, hospital and research institute |
Department of Anesthesiology, old opd building, ground floor
Pune
MAHARASHTRA |
9936036298
drshwetachitranshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr. D.Y. Patil Medical college, hospital and research centre |
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 |
caudal block using injection ropivacaine for circumcision in children |
Caudal block given using 0.2 mL/kg of 0.25% ropivacaine for post operative analgesia in pediatric patient posted for circumcision |
| Comparator Agent |
penile block using injection ropivacaine for circumcision in children |
penilel block given using 0.2 mL/kg of 0.25% ropivacaine for post operative analgesia in pediatric patient posted for circumcision |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Male |
| Details |
ASA grade I and ASA grade II fit patients.
Hemodynamically stable patients with all routine investigations within normal limits and without any other co-morbidities.
Availability of written and informed consent and willingness of the parent to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with ASA physical status III or more.
2. Patients posted for emergency procedures.
3. Patients with major neurological, cardiac, respiratory, renal, hepatic or coagulation abnormalities.
4. Patients having history of hypersensitivity to local anesthetic and opioids.
5. Patients having any contraindications to caudal block or penile block.
6. Patients having known fetal abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of caudal block and penile block using ropivacaine for postoperative analgesia in pediatric patients posted for circumcision. |
Monitored for vitals and analgesia for 24 hours postoperatively using VAS scoring more than 7 and FLACC scoring more than 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the following:
1. To evaluate the duration of the block postoperatively.
2. To compare any side-effect of the two blocks
|
Monitored postoperatively at 2 hrs, 4 hrs, 8 hrs , 24 hrs
VAS score more than 7 and FLACC score more than 5 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/10/2021 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
This is a randomized, prospective, single centre study comparing two procedures : caudal block and penile block using the drug Ropivacaine (0.25%) at a dose of 0.2 ml/kg IV for postoperative analgesia in pediatric patients posted for circumcision within 6 months duration in 30 patients ; 15 in each group. All the cases are done in India.
The primary outcome is to observe the duration of block and pain relief using Visual Analog Scoring (VAS) and FLACC (Face, Legs, Activity, Crying and Consolability) pain scale scoring. |