| CTRI Number |
CTRI/2025/07/089957 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Regional Nerve Block ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate Ultrasound guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair. |
|
Scientific Title of Study
|
A randomized controlled study of Ultrasound guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair at SMS Medical College, Jaipur. |
| 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 Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantari building, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
982820186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantari building, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
982820186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Sharma |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantari building, SMS Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
7988120484 |
| Fax |
|
| Email |
parulsharma221198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and attached hospitals, Jaipur |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantari complex, SMS Medical College, Jaipur, Rajasthan |
| Type of Sponsor |
Government 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 |
| Dr Parul Sharma |
SMS Medical college and attached hospitals |
Department of Anaesthesiology, Second floor, Dhanwantari building
Jaipur
RAJASTHAN |
7988120484
parulsharma221198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, SMS Medical College and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q64||Other congenital malformations ofurinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No block |
1.No block given
2.Intravenous analgesia (fentanyl/paracetamol) when required. |
| Intervention |
Ultrasound guided novel sacral erector spinae block |
1.Block given with 1 ml/kg 0.25% inj. bupivacaine
2.Intravenous analgesia (fentanyl/paracetamol) when required. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective hypospadias repair surgery.
2. Guardian willing to give informed written consent.
3. Patient of male sex with age group more than 2 years.
4.American Society of Anesthesiologists (ASA) physical status I-II. |
|
| ExclusionCriteria |
| Details |
1. Patient should not be part of any other study.
2. Patient allergic to any drug given during procedure.
3. Patient with local site infection.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative analgesic (Paracetamol) consumption (in mgs) over 24 hours. |
0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess time to first rescue analgesic. |
|
| 2.To assess postoperative pain using FLACC score. |
0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours. |
| 3. To assess side effects associated with block. |
0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/07/2025 |
| 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="0"
Months="3"
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 - NO
|
|
Brief Summary
|
This randomzied controlled study is being conducted at SMS Medical College and attached Hospitals, Jaipur to evaluate efficacy of Ultrasound guided novel sacral erector spinae block for post operative analgesia in pediatric patients undergoing hypospadias repair . A total of 66 patients will be enrolled and randomized into two groups (Group A with block and Group B with no block). Parameters such as postoperative analgesic consumption, time to first rescue analgesic and pain assessment using FLACC score will be recorded at predefined time intervals. The aim is to assess whether Ultrasound guided novel sacral erector spinae block provide adequate postoperative analgesia, thereby supporting safer anesthetic practices of pain management in hypospadias repair surgery. |