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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  
AIIMS, New Delhi, India 
 
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  
Status 
Not Applicable 
 
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.

 
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