| CTRI Number |
CTRI/2025/12/098534 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| 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 Comparing Two Types of Nerve Blocks for Pain Relief After Circumcision Surgery in Children |
|
Scientific Title of Study
|
Comparison of Analgesic Efficacy Between Ultrasound-Guided low dose Caudal Epidural Block versus Dorsal Penile Nerve Block in Pediatric patients undergoing Circumcision |
| Trial Acronym |
A Comparative Study of Ultrasound-Guided Caudal Epidural and Dorsal Penile Nerve Blocks for Analgesia in Pediatric Circumcision.” |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUDHEER R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of anaesthesiology
Room no-1920
Rajarajeswari medical college and hospital
202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheer_mys@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUDHEER R |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of anaesthesiology
Room no-1920
Rajarajeswari medical college and hospital
202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheer_mys@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr POORVIKA N S |
| Designation |
Junior resident |
| Affiliation |
Rajarajeswari medical college & hospital |
| Address |
Department of Anaesthesiology ROOM NO-1921
Rajarajeswari medical College & hospital
202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
Department of anaesthesiology room no-1921
Rajarajeswari medical College & hospital, 202, Mysore Road, Kengeri Satellite Town, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9535960758 |
| Fax |
|
| Email |
poorvikans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Rajarajeswari Medical College and Hospital, Bengaluru, Karnataka, India 560074 |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari medical college and hospital |
| Address |
Kambipura, Mysore Road, Bengaluru – 560074, Karnataka, India |
| 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 |
| Dr POORVIKA N S |
Rajarajeswari medical college and hospital |
Department of Anaesthesiology, Rajarajeswari Medical College and Hospital, Kambipura, Mysore Road, Bengaluru – 560074, Karnataka, India
Bangalore
KARNATAKA |
9535960758
poorvikans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z412||Encounter for routine and ritual male circumcision, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound-guided Caudal Epidural Block |
Children will receive ultrasound-guided caudal epidural block with 0.25% ropivacaine at a dose of 0.5 ml/kg after induction of anaesthesia and LMA insertion. Block performed before extubation. |
| Comparator Agent |
Ultrasound-guided Dorsal Penile Nerve Block (DPNB) |
Children will receive ultrasound-guided dorsal penile nerve block with 0.25% ropivacaine at a dose of 0.5 ml/kg after induction of anaesthesia and LMA insertion, before extubation.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Male |
| Details |
1.Male children aged 5 to 9 years
2.ASA physical status I or II
3.Scheduled for elective circumcision
4.Written informed consent obtained from parents or guardians
|
|
| ExclusionCriteria |
| Details |
1.ASA physical status III or higher
2.Known allergy or contraindication to local anesthetics
3.Coagulopathy or bleeding disorders
4.Infection at injection site
5.Congenital anomalies of sacrum or spine (for caudal block)
6.Neurological or developmental disorders
7.Parental refusal for participation
|
|
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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 |
| To determine the duration of pain relief by assessing the time until the first additional analgesic dose is required. |
FLACC SCORE at 1hour,4 hours, 8hours,12 hours,16 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Analgesic consumption
2. Adverse effects
3. Hemodynamics |
Intraoperative – 0, 5, 10, 15, 30 minutes
Postoperative – 1, 4, 8, 12, 16, 24 hours |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2025 |
| 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 prospective, randomized, parallel-group controlled trial aims to compare the analgesic efficacy of ultrasound-guided caudal epidural block versus dorsal penile nerve block (DPNB) in paediatric patients undergoing circumcision. Fifty ASA I–II male children aged 5–9 years will be randomly allocated into two groups (n=25 each). Group C will receive ultrasound-guided caudal epidural block with 0.25% ropivacaine (0.5 ml/kg), while Group D will receive ultrasound-guided DPNB with 0.25% ropivacaine (0.5 ml/kg), administered after induction of anaesthesia and before extubation. The primary outcome will be time to first rescue analgesia. Secondary outcomes will include postoperative FLACC pain scores over 24 hours, total rescue analgesic consumption, and incidence of adverse effects. Data will be analysed using SPSS v21, with p < 0.05 considered statistically significant.
|