| CTRI Number |
CTRI/2026/01/100242 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| 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
|
Which Pain-Relief Method Works as Well for Children After Hernia Surgery |
|
Scientific Title of Study
|
Comparison of ultrasound guided retrolaminar block versus caudal block for postoperative analgesia in paediatric patients undergoing unilateral inguinal hernia surgery: A double-blinded randomized controlled non-inferiority trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Bairagi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi, India |
| Address |
Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India
South DELHI 110029 India |
| Phone |
09953060597 |
| Fax |
|
| Email |
sushmita.bairagi91@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sushmita Bairagi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi, India |
| Address |
Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India
DELHI 110029 India |
| Phone |
09953060597 |
| Fax |
|
| Email |
sushmita.bairagi91@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yasha Chittora |
| Designation |
Postgraduate Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India
South DELHI 110029 India |
| Phone |
9789992907 |
| Fax |
|
| Email |
chittyasha026@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India,110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department Of Anesthesia |
Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India,110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Bairagi |
AIIMS, New Delhi, India |
Pediatric surgery Ot number 13,14,15, Department of Anesthesia,Pain Medicine and Critical Care, AIIMS, New Delhi, India,110029 South DELHI |
9953060597
sushmita.bairagi91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Postgraduate Research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Caudal block
(Comparator) |
After general anesthesia, for the caudal block, the patient will be placed in lateral position with hips and knees flexed, the sacral area will be prepared and draped under aseptic precautions. A linear ultrasound probe covered with a sterile sheath, will be positioned transversely over the sacral hiatus to identify the sacral cornua and the “frog-eye” sign, then rotated longitudinally to 90 degrees to visualize the sacrococcygeal ligament and caudal canal (sagittal view). A 50 mm needle will be advanced at a 20° angle under real-time ultrasound guidance until a “pop” is felt as the ligament is pierced, and 0.75 mL/kg of 0.2% ropivacaine will be injected into the caudal epidural space. |
| Intervention |
Ultrasound Guided Retrolaminar block (Intervention) |
After general anesthesia, for the retrolaminar block, the patient will be placed in lateral position with hips and knees flexed, the thoracolumbar region will be prepared and draped aseptically. The linear ultrasound probe will be placed longitudinally at the T12 spinous process and moved laterally to identify the lamina. A 50 mm in-plane needle will be advanced from cranial to caudal direction until the tip lies between the lamina and erector spinae muscle, where 0.75 mL/kg of 0.2% ropivacaine will be deposited under ultrasound visualization. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Paediatric patients aged 2–10 years.
2)ASA physical status I or II.
3)Scheduled for unilateral open hernia repair under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1)Neurological deficits or spinal anomalies.
2)Coagulopathy or bleeding disorders.
3)Allergy to local anaesthetics.
4)Infection, redness, or abnormality at the injection site.
5)Intellectual disability or psychiatric disorder
|
|
|
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 |
| Postoperative pain score at 6 hours at rest, assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. |
at 6 hr at rest post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total intraoperative fentanyl requirement (µg/kg) in both groups.
|
whole intraoperative period of surgery after the block is given till the surgery is ended |
Postoperative pain scores assessed using the FLACC scale:
At rest: at 1, 2, 4 hrs postoperatively.
During movement: at 1, 2, 4, and 6 hours postoperatively.
“Movement” will be defined as active or passive flexion of the hip or gentle lifting of the operated limb to simulate normal postoperative activity
|
At rest- 1,2,4 hrs
At movement-1,2,4,6 hr |
| Time to first rescue analgesic requirement, defined as the time from completion of surgery to administration of the first dose of rescue analgesic (IV fentanyl 0.5 µg/kg). |
from end of surgery till rescue analgesia is given (will be checked for a period of 6 hrs in postop till discharge) |
| Total rescue analgesic consumption within the first 6 postoperative hours. |
first 6 hrs of postop till discharge |
| Incidence of block-related and postoperative complications, such as nausea, vomiting, urinary retention, motor weakness, vascular puncture, or local site swelling. |
From time since block is given in the intraoperative period till next day of surgery |
| Parental satisfaction score at discharge, assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied) |
at 6 hrs before discharge |
|
|
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)
|
22/01/2026 |
| 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="2" Months="0" 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 prospective randomized double blind parallel group active controlled non inferiority clinical trial conducted at the All India Institute of Medical Sciences New Delhi. A total of sixty six pediatric patients aged two to ten years undergoing unilateral open inguinal hernia surgery under general anesthesia will be randomly allocated using a computer generated random number sequence into two groups of thirty three each. Group A will receive ultrasound guided caudal block and Group B will receive ultrasound guided retrolaminar block. Participants children and parents and the outcome assessor will remain blinded to group allocation. Postoperative pain will be assessed using the FLACC scale Face Legs Activity Cry Consolability at rest and during movement at one two four and six hours after surgery. The primary outcome will be the FLACC score at six hours at rest. Secondary outcomes include FLACC scores at other time points intra and postoperative fentanyl requirement time to first rescue analgesia total rescue analgesic consumption block related complications Modified Post Anaesthesia Discharge Score at discharge and parental satisfaction. Rescue analgesia with intravenous fentanyl which will be given if FLACC score is more than four. As this is a day care surgery children will be discharged after six to eight hours once Modified PADS score is nine or above. At home parents will give syrup ibuprofen ten milligram per kilogram every eight hours as needed. On the next day parents will be contacted telephonically to ask about pain control excess use of ibuprofen and return to normal activity. The study aims to determine whether the retrolaminar block is non inferior to the caudal block in providing safe and effective postoperative pain relief in children undergoing day care inguinal hernia surgery. |