| CTRI Number |
CTRI/2024/06/069156 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study compare whetherisolated anesthesia of male external genital organ or caudal block for children undergoing operation on male genitals. |
|
Scientific Title of Study
|
Comparison of analgesic effect of USG guided caudal block and USG guided penile block for children going for circumcision surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pujaben barad |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, Department of Anaesthesiology, GMERS Medical College Junagadh
GMERS Medical College Junagadh
Junagadh
GUJARAT
362001
India |
| Phone |
9601377008 |
| Fax |
|
| Email |
poojabarad28.pb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pujaben barad |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, Department of Anaesthesiology, GMERS Medical College Junagadh
GMERS Medical College Junagadh
GUJARAT
362001
India |
| Phone |
9601377008 |
| Fax |
|
| Email |
poojabarad28.pb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pujaben barad |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, Department of Anaesthesiology, GMERS Medical College Junagadh
GMERS Medical College Junagadh
GUJARAT
362001
India |
| Phone |
9601377008 |
| Fax |
|
| Email |
poojabarad28.pb@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College Junagadh , Gujarat,bIndia , 362001. |
|
|
Primary Sponsor
|
| Name |
DR Pujaben barad |
| Address |
310, Department of Anaesthesiology GMERS Medical College, Junagadh, Gujarat. India |
| 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 pujaben barad |
GMERS medical college junagadh |
Block no 307, Surgical operation yhetre, GMERS Medical College, majevadi gate, Junagadh,Gujarat,India.
Junagadh
GUJARAT |
9601377008
poojabarad28.pb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, GMERS Medical College,Junagadh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N472||Paraphimosis, (2) ICD-10 Condition: N471||Phimosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided caudal block |
Application of USG guided caudal epidural block with 0.25% bupivacaine according to weight of the patient after induction of anesthetisia. |
| Comparator Agent |
USG guided penile block |
application of USG guided penile block with 0.25% bupivacaine according to weight of the patient after induction of anesthetisia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Male |
| Details |
1) patient posted for circumsion surgery
2) age between 2 to 6 years
3) patients giving written valid consent
4) ASA physical status 1,2,3. |
|
| ExclusionCriteria |
| Details |
1) Patients with poor glasgow coma scale
2) patients with skin lession at local site
3) patient with local anesthetic allergy
4) Patient requiring spinal Anesthesia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of postoperative analgesic effect using FLACC behavioural scale |
Assessment of postoperative analgesic effect using FLACC behavioural scale at post operative 1,2,4,6,8 and 10 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare total duration of hospital stay and compliance between 2 groups |
upto 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a interventional trial comparing pain relief effect of sonography guided 2 different approaches for postoperative pain relief in children undergoing procedure at their male private part. Pain relief effect will be assessed using a specific scientific scale at multiple times postoperatively and will be compared using standard statistical tests. |