| CTRI Number |
CTRI/2025/08/093685 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two pain relief techniques after genital surgery in children |
|
Scientific Title of Study
|
Comparison of sacral erector spinae plane block with caudal block for post-operative analgesia in paediatric patients undergoing penoscrotal surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth R |
| Designation |
Postgraduate |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,
VMMC and Safdarjung Hospital,
Ansari Nagar East,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9952589435 |
| Fax |
|
| Email |
prashraj07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sapna Bathla |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,
VMMC and Safdarjung Hospital,
Ansari Nagar East,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9582358200 |
| Fax |
|
| Email |
sapnapearl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Bathla |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,
VMMC and Safdarjung Hospital,
Ansari Nagar East,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9582358200 |
| Fax |
|
| Email |
sapnapearl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical college and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital,
Ansari Nagar West,
New Delhi
110029 |
| 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 Prasanth R |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and Intensive care
VMMC and Safdarjung Hospital
Ansari Nagar East
New Delhi
New Delhi
DELHI |
9952589435
prashraj07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q54||Hypospadias, (2) ICD-10 Condition: N471||Phimosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal Block |
Patients fulfilling the inclusion criteria will be included in the study. Detailed pre-anesthetic checkup will be done. Following patient details will be noted: Age, Gender, Weight, ASA class, Diagnosis, Planned Surgery. Random allocation 1:1 will be done into two groups: Sacral Erector Spinae Plane block and Caudal Block. Standard monitors will be attached: Pulse Oximetry, Non-invasive blood pressure (NIBP), Electrocardiography (ECG). Any additional monitoring deemed necessary for the surgery will also be used. Baseline heart rate, oxygen saturation and non-invasive blood pressure would be recorded. Induction of general anaesthesia will either be inhalational (with sevoflurane) or intravenous (with propofol dosed till unconscious), depending upon whether the patient has allowed preinduction intravenous cannulation. In either case, patient will receive intravenous Injection Fentanyl 2mcg/kg and 0.25 mg/kg Injection Atracurium. After adequate time for intermittent positive pressure ventilation, appropriately sized Proseal LMA shall be inserted and inflated with appropriate volume of air. After confirming correct placement, LMA shall be secured and mechanical ventilation initiated. The patient will be turned to lateral position to perform a caudal epidural block. After aseptic
preparation of the block site, a high-frequency linear ultrasound probe will be placed transversely over the coccyx to obtain the transverse sonographic view of the sacral hiatus.
Then, the transducer will be rotated to 90° to obtain a longitudinal view of the sacral hiatus. A 21-gauge, 38 mm needle will be inserted from the probe’s edge using an in-plane technique and then advanced into the sacral canal through the sacrococcygeal membrane. After negative aspiration, 0.5 ml/kg of 0.25% bupivacaine will be administered as per ‘Modified Armitage Dosing Regimen’. Patient will be made supine again and handed over to the surgical team. |
| Intervention |
Sacral Erector Spinae Plane Block |
Patients fulfilling the inclusion criteria will be included in the study. Detailed pre-anesthetic
checkup will be done. The purpose and procedure of the study will be explained to the
guardians of the patients, and an informed written consent will be obtained. A patient
information sheet shall be provided. The technique of both the blocks will be explained to the
patients/ parents. Any queries regarding the study will be resolved. Following patient details
will be noted: Age, Gender, Weight, ASA class, Diagnosis, Planned Surgery. Random
allocation 1:1 will be done into two groups: Sacral Erector Spinae Plane block and Caudal
Block. Standard monitors will be attached: Pulse Oximetry, Non-invasive blood pressure (NIBP),
Electrocardiography (ECG). Any additional monitoring deemed necessary for the surgery will
also be used. Baseline heart rate, oxygen saturation and non-invasive blood pressure would be
recorded.
Induction of general anaesthesia will either be inhalational (with sevoflurane) or intravenous
(with propofol dosed till unconscious), depending upon whether the patient has allowed
preinduction intravenous cannulation. In either case, patient will receive intravenous Injection
Fentanyl 2mcg/kg and 0.25 mg/kg Injection Atracurium. After adequate time for intermittent positive pressure ventilation, appropriately sized Proseal
LMA shall be inserted and inflated with appropriate volume of air. After confirming correct
placement, LMA shall be secured and mechanical ventilation initiated. The patient will be turned to lateral position to perform Sacral Erector Spinae Plane block.
After aseptic preparation of the block site, a high-frequency linear ultrasound probe will be
placed longitudinally in the midline just over the sacrum. Median sacral crests and erector
spinae muscles will be identified. An appropriately sized block needle will be inserted using
an in-plane technique and will be advanced from cranial to caudal direction until its tip touches
the top of the fourth median sacral crest. Following negative aspiration, 0.5 ml/kg of 0.25%
bupivacaine will be administered. Patient will be made supine again and handed over to the
surgical team |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Male |
| Details |
Paediatric male patients, aged 1–7 years, with American Society of Anesthesiologists (ASA) physical status I or II, scheduled to undergo elective penoscrotal surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with spinal anomalies, altered mental status, history of developmental delay
2. Infection at the site of injection
3. Documented allergy to local anaesthetic agents
4. Additional surgical procedures at different surgical sites |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare duration of analgesia (time to first rescue analgesia) in Sacral erector spinae plane
block group and Caudal block group in paediatric patients undergoing penoscrotal surgery
under general anaesthesia. |
From completion of block until first administration of rescue analgesia within 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain scores using FLACC scale |
At 0h(Immediate postoperative period),1h, 2h, 4h, 6h, 12h and 24h. |
| Total postoperative oral Ibuprofen Consumption(mg) in 24 hours |
Cumulative dose from 0-24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2025 |
| 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="1"
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 study will compare two different anaesthesia techniques, the sacral erector spinae plane block and the caudal block for controlling pain after genital surgery in children. Children undergoing surgery for conditions like hypospadias or circumcision under general anaesthesia will be randomly assigned to receive one of these blocks. Pain scores, duration of pain relief, and the amount of additional pain medicine needed in the first 24 hours after surgery will be recorded and compared between the two groups. |