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CTRI Number  CTRI/2026/01/102330 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
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   Pain relief with two block in children undergoing Developmental Dysplasia of Hip Surgery  
Scientific Title of Study   Comparison of Erector Spinae Plane block versus Caudal block for Postoperative analgesia in children undergoing Developmental Dysplasia of Hip Surgery - A Prospective Randomized Control 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  Dr Ajay Shanakr S 
Designation  Post graduate  
Affiliation  Department of Anaesthesiology All India Institute of Medical Sciences ,Jammu  
Address  113 MGR Nagar VK Road Pernambut
DEPARTMENT OF ANAESTHESIA ,Flat No.403 Triveni Hostel AIIMs JAMMU
Vellore
TAMIL NADU
635810
India 
Phone  8973175667  
Fax    
Email  ajayshankar1711@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raksha Kundal 
Designation  Associate Professor 
Affiliation  Department of Anaesthesiology All India Institute of Medical Sciences , Jammu 
Address  AIIMS Jammu

Jammu
JAMMU & KASHMIR
184120
India 
Phone  9910939123  
Fax    
Email  Raksha.kundal@aiimsjammu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Raksha Kundal 
Designation  Associate Professor 
Affiliation  Department of Anaesthesiology All India Institute of Medical Sciences , Jammu 
Address  AIIMS Jammu

Jammu
JAMMU & KASHMIR
184120
India 
Phone  9910939123  
Fax    
Email  Raksha.kundal@aiimsjammu.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  AIIMS VIJAYPUR JAMMU 184120 JAMMU & KASHMIR INDIA 
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 Ajay Shankar S  All India Institute Of Medical Sciences ,Jammu  1ST FLOOR OT COMPLEX ,DEPARTMENT OF ANAESTHESIOLOGY
Jammu
JAMMU & KASHMIR 		 8973175667

ajayshankar1711@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS,jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M259||Joint disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USG Caudal Block  After induction of anaesthesia,With the help of ultrasound Caudal block given by using 0.5ml/kg of 0.25% bupivacaine 
Intervention  USG Erector Spinae Plane Block  ESPB will be performed on the side of operation at L2 – L3 level using linear transducer of Ultrasound Machine . After induction of anaesthesia, unilateral block will be performed in lateral decubitus position with blocking side facing upwards.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Paediatric patient of ASA I-II
1 - 7yrs of age either sex undergoing developmental dysplasia of hip surgery 
 
ExclusionCriteria 
Details  Parent or guardian refusal to participate.
Infection at the local site of injection.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean FLACC scale at 15min,30mins,40mins,60mins,2hrs,6hrs,12hrs,24hrs.  Mean FLACC scale at 15min,30mins,40mins,60mins,2hrs,6hrs,12hrs,24hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
The mean time for requirement of first rescue analgesia as determined by FLACC   At the end 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   13/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  
This trial is a prospective randomized controlled study comparing the effectiveness of Erector Spinae Plane Block (ESPB) versus Caudal Block (CB) for postoperative pain management in children undergoing Developmental Dysplasia of Hip (DDH) surgery. The primary goal is to assess which of these two ultrasound-guided regional anesthetic techniques provides superior postoperative analgesia.

Developmental Dysplasia of Hip surgery can cause significant pain in children, making effective pain control essential for recovery and to minimize opioid use. The Caudal Block, while a conventional method, has potential risks and limited duration. The Erector Spinae Plane Block is a newer, less invasive technique that may offer a safer and longer-lasting alternative, but its efficacy in pediatric hip surgery needs further investigation.

The study will include 44 pediatric patients, aged 1 to 7 years, classified as ASA I-II, who are undergoing elective DDH surgery at the All India Institute of Medical Sciences, Vijaypur, Jammu. Patients will be randomly assigned into two equal groups: one receiving an Ultrasound Guided Caudal Block and the other an Ultrasound Guided Erector Spinae Plane Block. Randomization will be computer-generated to ensure unbiased group assignment, and assignments will be blinded to researchers and statisticians.

Before surgery, patients will receive premedication. General Anesthesia will be administered, and both regional blocks will be performed under ultrasound guidance. The ESPB will be administered at the L2-L3 level, and the CB at the sacral hiatus, with 0.5 ml/kg of 0.25% bupivacaine injected in both cases.
The primary outcome measure will be postoperative analgesia, assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) pain scale at multiple time points (0, 15, 30, 45, 60 minutes, 2, 6, 12, and 24 hours) after surgery. All patients will receive routine paracetamol. Rescue analgesia (Syrup Ibuprofen) will be given if the FLACC score is 4 or higher, and the time to the first rescue analgesia will be recorded.

Secondary outcomes include the mean time to first rescue analgesia, the total number of rescue analgesic doses consumed within 24 hours, parental satisfaction with pain relief, the number of attempts to successfully perform the block, and the incidence of block-related complications such as nausea, vomiting, hematoma, or urinary retention.

The study is designed with ethical considerations, including approval from the Institutional Ethics Committee and obtaining informed consent from parents or guardians. Patient confidentiality will be maintained, and participants can withdraw from the study at any time without affecting their medical care. The trial is scheduled from January 2026 to November 2026, followed by data analysis and dissemination of results. This research aims to identify the optimal regional anesthetic technique for postoperative pain management in this specific pediatric surgical population.
 
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