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CTRI Number  CTRI/2025/10/096515 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 25/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Erector spinae plane block versus caudal block for postoperative analgesia in pediatric inguinal hernia surgery 
Scientific Title of Study   A randomized controlled study to compare effectiveness of Erector spinae plane block versus caudal block for postoperative analgesia in pediatric inguinal hernia surgery under general anesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Dogra 
Designation  Senior professor 
Affiliation  SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology 2nd floor Dhanvantari building, SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN

Jaipur
RAJASTHAN
302001
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelam Dogra 
Designation  Senior professor 
Affiliation  SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology 2nd floor Dhanvantari building, SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN

Jaipur
RAJASTHAN
302001
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Saini 
Designation  Junior Resident 
Affiliation  SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology 2nd floor Dhanvantari building, SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN

Jaipur
RAJASTHAN
302001
India 
Phone  9509511533  
Fax    
Email  dr.rajeshsaini533@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN 
 
Primary Sponsor  
Name  Department of anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Anaesthesiology 2nd floor Dhanvantari building, SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN 
Type of Sponsor  Government medical college 
 
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 Neelam Dogra  SMS MEDICAL COLLEGE AND HOSPITAL  Department of Anaesthesiology 2nd floor Dhanvantari building, SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR RAJASTHAN
Jaipur
RAJASTHAN 		 9928709289

neelam_dogra24@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS  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 
Intervention  1.Erector spinae plane block 2.Caudal Block  To compare effectiveness of Erector spinae plane block (using 0.5ml per kg of 0.2 percent Ropivacaine) versus Caudal block (using 1ml per kg of 0.2 percent Ropivacaine) for postoperative analgesia in pediatric inguinal hernia surgery under general anaesthesia 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children undergoing elective unilateral hernia repair
Patients belonging to ASA grade I and II
Children of either sex
children of 10 to 25 kg body weight
Guardian willing to give consent
 
 
ExclusionCriteria 
Details  Children with a history of allergy to local anaesthetics
Children undergoing bilateral inguinal hernia surgeries
Local infection at the proposed site of block
Children with bleeding or coagulation disorders
Children with anatomical abnormalities of the spine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean FLACC pain score in first 24 hrs
Mean Time to first rescue analgesia
Mean number of rescue analgesia in first 24 hours
Mean change in hemodyanamic parameters
Side effects if any 		 30 minutes
1 hour
2 hours
4 hours
6 hours
8 hours
12 hours
24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/11/2025 
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="0"
Months="2"
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 herniotomy is a commonly performed day care procedure in pediatric patients and post operative analgesia is crucial for peri operative care. Failure to adequately control post operative pain can lead to negative behavioral changes and parental dissatisfaction.
Caudal block is the gold standard for pain management in children undergoing lower abdominal surgeries due to its enhanced reliability and safety profile. However a notable drawback of this technique is its limited duration of action following single injection. Thus several interfacial plane blocks have been suggested as alternatives for postoperative analgesia in children including quadratus lumborum block, transverse abdominis plane block,rectus sheath block and Erector spinae plane block
The USG guided Erector spinae plane block is gaining popularity in pediatrics due to its potential for managing post operative pain in various surgeries as it is relatively easy to perform with no complications.
We plan to conduct this double blind randomised controlled study to compare the effectiveness of Erector spinae plane block versus Caudal block for post-operative analgesia in children undergoing inguinal hernia repair.
 
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