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CTRI Number  CTRI/2024/07/071598 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
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   ultrasound versus landmark-guided caudal block in infants 
Scientific Title of Study   Comparison of ultrasound versus landmark-guided caudal block in neonates and infants: A randomized controlled study 
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 Jayanam patel 
Designation  Resident doctor in Department of Anaesthesiology 
Affiliation  Government medical college,baroda 
Address  Resident doctor Department of Anesthesia, Government Medical College, Baroda Vadodara GUJARAT

Vadodara
GUJARAT
390001
India 
Phone  8155854997  
Fax    
Email  jayanam.patel98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDevyani Desai 
Designation  Associate professor in department of Anaethesiology 
Affiliation  Government medical college,Baroda 
Address  Associate Professor Department of Anesthesia, Government Medical College, Baroda Vadodara GUJARAT

Vadodara
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayanam patel 
Designation  Resident doctor in department of anaethesiology 
Affiliation  Government medical college, baroda 
Address  Resident doctor of Department of Anaesthesiology, Government Medical College, Baroda Vadodara GUJARAT

Vadodara
GUJARAT
390001
India 
Phone  8155854997  
Fax    
Email  jayanam.patel98@gmail.com  
 
Source of Monetary or Material Support  
Government medical college baroda department of anaesthesia , india , gujrat , baroda Pincode -390001 
 
Primary Sponsor  
Name  Medical college baroda department of anaesthesia india gujrat 
Address  Medical College Baroda, Vinoda Bhave Road, Anandpura, Vadodara Pin code -390001 
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 
DrJayanam patel  SSG Hospital  4th floor, OT Block, Department of Surgery, Baroda Medical College Vadodara GUJARAT
Vadodara
GUJARAT 		 8155854997

jayanam.patel98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for biomedical& health research, government medical college baroda  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  LANDMARK GUIDED CAUDAL BLOCK  The patient will be put in a lateral decubitus position with hip and knee flexed. Under strict aseptic precaution, sacral cornua and sacral hiatus will be palpated over the skin. 24gauge hypodermic needle will be inserted at 60–80 degrees angle with the skin surface and will be advanced until the sacrococcygeal ligament will be passed with a “pop” by the “standard loss of resistance” technique for identification of the caudal space. Then the angle will be reduced by 20–30 degrees and the needle will be advanced further by 2–3 mm, till the sacral canal will be entered. The syringe will be aspirated for blood/CSF and once the position is confirmed, the anaesthetic drug will be administered.  
Intervention  ULTRASOUND GUIDED CAUDAL BLOCK  The patient will be put in a lateral decubitus position with hip and knee flexed. The field will be prepared with a sterilizing solution and a sterile drape covering the ultrasound probe in a sterile cover Initial scanning in the transverse plane will be done for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the ‘frog-eye sign’. Then, the probe will be rotated 90 degrees to acquire a longitudinal view. The needle is advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament. Once the needle is confirmed to be in the caudal space on the screen, careful aspiration will be done to confirm the absence of CSF or blood. The use of a saline bolus (0.1-0.2 ml/kg) can be performed to confirm correct positioning. If this is the case, real-time visualization of the cranial spread of the saline with anterior displacement of the posterior dura is seen. Then the local anaesthetic, Bupivacaine 0.125%, 1ml/kg will be injected slowly under direct supervision of ultrasound. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  1. Patients undergoing posted for elective or emergency lower abdominal surgery like non-obstructed inguinal hernia, anoplasty, colostomy, circumcision etc.
2. Term neonates and age £ 1 year

3. Patients conformed to American Society of Anaesthesiologists (ASA) physical status -II-III in preoperative assessment

4. Ability to follow the study protocol by parents 
 
ExclusionCriteria 
Details  1) Neonates with upper/midgut obstruction
2) Coagulation abnormalities
3) Sacral anomalies
4) Long-duration surgeries with major fluid shifts
5) Neuromuscular or metabolic disorders
6) Systemic infection
7) Meningitis
8) Local infection at the site of puncture
9) Raised intra-cranial tension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.1st Attempt success rate  At basline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to perform the block
2. Number of needle punctures required for successful block
3. Tachycardia on putting incision
4. Duration of post-op analgesia
5. Complication of block 		 From starting point to 24 hr 
 
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   Phase 4 
Date of First Enrollment (India)   05/08/2024 
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 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   The aim of our study is compare the first attempt success rate and efficacy of ultrasound versus landmark guided caudal block.80 patients belonging to age group <= 1 year with ASA II or III are randomly selected into two groups.In group US ultrasound guided caudal block given to neonates and infants and in group LB landmark guided caudal block given to neaonates and infants. The primary objective is to compare the first attempt success rate in both group.Block performance time, number of needle puncture,tachycardia on putting incision, duration if post operative analgesia,complication of block are the secondary parameters and also noted in both the groups. The proposed advantage of our study is first attempt success rate is higher in ultrasound guided caudal block. 
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