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CTRI Number  CTRI/2025/04/085561 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Easing Postoperative Pain in Children: Comparing Two Nerve Block Techniques After Hernia Surgery 
Scientific Title of Study   Comparative evaluation of postoperative analgesia between ultrasound guided lumbar erector spinae plane block and ilioinguinal-iliohypogastric block in children undergoing inguinal hernia surgeries: A Randomised Controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lavanya S 
Designation  Fellow in Paediatric Anesthesia  
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Raja Ram Kohli Marg Geeta Colony

New Delhi
DELHI
110031
India 
Phone  9944573104  
Fax    
Email  lavanyasundaram20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Geeta Kamal 
Designation  Senior specialist  
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Raja Ram Kohli Marg Geeta Colony

New Delhi
DELHI
110031
India 
Phone  9643308229  
Fax    
Email  kmlgeeta@rediff.com  
 
Details of Contact Person
Public Query
 
Name  Geeta Kamal 
Designation  Senior specialist  
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Raja Ram Kohli Marg Geeta Colony

New Delhi
DELHI
110031
India 
Phone  9643308229  
Fax    
Email  kmlgeeta@rediff.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalaya 
Address  Raja Ram Kohli Marg Geeta Colony New Delhi 110031 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lavanya S  Chacha Nehru Bal Chikitsalaya  Department of Anaesthesia Raja Ram Kohli Marg Geeta Colony New Delhi 110031
New Delhi
DELHI 
9944573104

lavanyasundaram20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chacha Nehru Bal Chikitsalaya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ilioinguinal- iliohypogastric nerve block   This is ultrasound guided peripheral nerve block with 0.5ml/kg of 0.25% bupivacaine and 0.5mcg/kg of dexmedetomidine given only once before surgery.  
Intervention  Lumbar erector spinae plane block  This is ultrasound guided peripheral nerve block with 0.5ml/kg of 0.25% bupivacaine and 0.5mcg/kg of dexmedetomidine given only once before surgery.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Age 3 to 8 years
ASA physical status I and II
Posted for elective inguinal hernia surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  • History of developmental delay/ mental retardation
• Patients undergoing laparoscopic herniotomy/ bilateral open herniotomy
• Anomalies of spine and central nervous system
• History of allergy to drugs used in study.
• History of bleeding disorders
• Infection at injection site
• Parent refusal to the procedure
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to requirement of first rescue analgesia in the postoperative period  From the time of administration of the nerve block till the requirement of postoperative analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of complications like hypotension, bradycardia, nausea and vomiting, apnea, desaturation
Postoperative sedation scores 
Till 24hours postoperative  
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   02/05/2025 
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="0"
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   Inguinal hernia surgery is a daycare procedure. Paediatric patients who are undergoing inguinal hernia surgeries experience pain intraoperatively and postoperatively which persists as a chronic pain. Caudal analgesia was the preferred regional technique till date. However this technique has its own limitations like short duration of action and complications because of the drug administration in the epidural space. To overcome these we are comparing ultrasound guided Erector spinae plane block and ilioinguinal-iliohypogastric nerve block which are plane blocks. They are simple effective and with less complications. The postoperative anlagesia will be evaluated using Wong bakers faces pain rating scale and postoperative sedation will be evaluated using Ramsay sedation score. ASA I and II patients of age 3 to 8 years are included in the study who are undergoing inguinal hernia surgery on an elective basis. The primary outcome will be to evaluate the time to first rescue analgesia between two groups in the postoperative period. The secondary outcome is to compare the incidence of the complications like apnea, desaturation and hypotension.
The study will be conducted for a period of 1 year.
Sample size was calculated by assuming mean difference in time to first rescue analgesia between ilioinguinal iliohypogastric nerve block group and Erector spinae plane block group as 250 mins as per El.Emam Em et al. The required sample size will be 26 per group approximately. Considering drop out ratio of 10% 3 patients added to each group making approximately 29 in each group. 

 
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