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CTRI Number  CTRI/2025/11/098197 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
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   A study comparing ultrasound and formula methods to decide the right amount of medicine for a caudal pain-relief injection in children during surgery 
Scientific Title of Study   Comparison of Ultrasound-Guided and Formula-Based Volume Determination for Caudal Block Analgesia in Pediatric Patients: 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  Dr. Akanksha Tyagi 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anesthesiology, Level 6, Medical College Building, AIIMS Rishikesh, Virbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  08072117950  
Fax    
Email  akkushippu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Yashwant Singh Payal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anesthesiology, Level 6, Medical College Building, AIIMS Rishikesh, Virbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9411789762  
Fax    
Email  yashwant.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr Yashwant Singh Payal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anesthesiology, Level 6, Medical College Building, AIIMS Rishikesh, Virbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9411789762  
Fax    
Email  yashwant.anaes@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
AIIMS Rishikesh, Virbhadra marg, Rishikesh, Uttarakhand,India Pincode: 249203  
 
Primary Sponsor  
Name  AKANKSHA TYAGI 
Address  All India Institute of Medical Sciences Rishikesh, Virbhadra marg, Rishikesh Dehradun UTTARANCHAL 249203 India  
Type of Sponsor  Other [Self] 
 
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 Akanksha Tyagi  AIIMS Rishikesh  Department of Anaesthesiology Level 6, Medical College building
Dehradun
UTTARANCHAL 		 08072117950

akkushippu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, RISHIKESH  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 
Comparator Agent  Modified Spiegel Formula Based Caudal Epidural Block  Caudal block performed using a pre-calculated volume of 0.25 percent Ropivacaine determined by the modified Spiegel formula based on spinal height to achieve block up to T10 level. Needle placement is confirmed under ultrasound guidance. The drug is injected slowly at the rate of 0.5 ml per second after confirming negative aspiration for blood or cerebrospinal fluid. The entire intervention lasts approximately 3–5 minutes and is performed once intra-operatively. 
Intervention  Ultrasound Guided Caudal Epidural Block  Caudal block performed under real-time ultrasound guidance using a high-frequency linear probe to identify the sacral hiatus and visualise drug spread. 0.25 percent Ropivacaine is injected slowly at the rate of 0.5 ml per second until Doppler visualisation confirms spread up to the T10 level. The total volume of the drug injected is recorded. The entire intervention lasts approximately 4–6 minutes and is performed once intra-operatively. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Pediatric patients of either Gender aged between 1 and 6 years
American Society of Anaesthesiologists (ASA) physical status I, II
Patients undergoing infra-umbilical surgery
 
 
ExclusionCriteria 
Details  Refusal to participate
Allergy to local anaesthetic
Coagulopathy
Infection at the injection site
Lumbosacral deformity
Neurological disorders (e.g., cerebral palsy, developmental delay affecting sensory/motor assessment) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Volume of 0.25% Ropivacaine (mL) required to achieve sensory block up to T10 dermatome level.  Assessed intra-operatively at the time of caudal block administration — from needle insertion to completion of drug injection (approximately 0–6 minutes). 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative pain using FLACC (Face, Legs, Activity, Cry, Consolability) score  Postoperatively at 5, 10, 15, 20, 25, and 30 minutes, and then hourly up to 24 hours 
Maximum sensory block level achieved  Within 30 minutes after caudal block, tested by response to cold stimulus using spirit-soaked cotton; absence of response recorded as level of sensory block. 
Incidence of adverse effects (hypotension, bradycardia, motor weakness, urinary retention, local anaesthetic toxicity)  intraoperative and up to 24 hours postoperatively 
Motor block assessment using Modified Bromage Scale  Every 5 minutes up to 30 minutes post-block 
Duration of Post-operative Analgesia  Duration of Analgesia from completion of block until first rescue analgesia ( when FLACC score is more than or equal to 4) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/12/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akkushippu@gmail.com].

  6. For how long will this data be available start date provided 10-11-2025 and end date provided 10-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomised controlled trial compares ultrasound-guided and formula-based volume determination for caudal block analgesia in children aged 1 to 6 years undergoing infra-umbilical surgeries. 80 ASA I AND II patients will be randomly allocated into the two groups. In the ultrasound group, 0.25% Ropivacaine will be administered under real-time ultrasound guidance until spread is visualised up to the T10 level. In the modified Speigel formula group, the volume will be pre-calculated based on spinal height. The primary outcome is the volume of drug required to achieve a T10 sensory block. Secondary outcomes include postoperative pain score, duration of analgesia, maximum sensory level and adverse effects.
 
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