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CTRI Number  CTRI/2025/07/091837 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   “Studying Finger Pulse Changes to Detect the Effect of Nerve Block in Children Undergoing Surgery Under Anesthesia” 
Scientific Title of Study   A prospective observational clinical trial to assess the efficacy of perfusion index (PI) as a predictor of onset of pediatric caudal block 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  SINGAREDDY SUMANTH KUMAR REDDY 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
Belgaum
KARNATAKA
590010
India 
Phone  8448365364  
Fax    
Email  DOCSUMANTHREDDY@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  MANJUNATH C PATIL 
Designation  PROFESSOR 
Affiliation  Jawaharlal Nehru Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
Belgaum
KARNATAKA
590010
India 
Phone  9743322063  
Fax    
Email  MCPATIL52@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  SINGAREDDY SUMANTH KUMAR REDDY 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010
Belgaum
KARNATAKA
590010
India 
Phone  8448365364  
Fax    
Email  DOCSUMANTHREDDY@GMAIL.COM  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka, India 
 
Primary Sponsor  
Name  SINGAREDDY SUMANTH KUMAR REDDY 
Address  DEPARTMENT OF ANAESTHESIOLOGY J.N MEDICAL COLLEGE, BELAGAVI, KARNATAKA -590010 
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 SINGAREDDY SUMANTH KUMAR REDDY  KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre  2nd floor, Department of Anaesthesiology, JNMC,Belgaum
Belgaum
KARNATAKA 
08448365364

DOCSUMANTHREDDY@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Medical and Surgical 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2, undergoing infraumbilical surgeries 
 
ExclusionCriteria 
Details  who are allergic to local anaesthetics, with coagulation abnormalities, spinal abnormalities, neurological deficits and infection at the site of caudal block 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.  first 20 minutes during surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor PI trends after caudal epidural anesthesia in children  first 20 minutes during surgery 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   10/08/2025 
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 - 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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [DOCSUMANTHREDDY@GMAIL.COM].

  6. For how long will this data be available start date provided 13-07-2025 and end date provided 13-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Caudal block under general anesthesia is quite popular for pediatric lower limb surgeries as it is one technique that fits all. It is relatively easy to learn with a high mean success rate and a remarkable safety record. However, failure of the caudal block is about 4% due to abnormal anatomy, operator inexperience and wrong choice of block.

It is often very difficult to assess the quality of analgesia in children intra-operatively as most of the regional blocks are performed under general anesthesia or sedation in contrast to adults. Conventionally one waits to see the patient’s response to the surgical skin incision to make a clinical decision of working caudal block. Unsuccessful block causes a raise in HR, Blood Pressure on skin due to pain. This calls for more reliable and faster objective parameters that can confirm the efficacy of caudal block in children.

Recent advances in Pulse Oximeter technology have broadened the ability to measure more parameters such as Perfusion Index (PI). PI is a noninvasive numerical assessment of the pulsatile strength at a monitoring site providing useful information about the peripheral perfusion status of the patient. A decrease in PI can occur because of local vasoconstriction while vasodilatation results in an increase in PI in the skin at the monitoring site. Recent studies recommended that PI can be used as an early and sensitive indicator to detect the development of epidural-induced sympathectomy leading to vasodilation and increased perfusion in adults. In adult population many numbers of studies done and most of them concluded that PI is the best tool in predicting the onset and adequacy of caudal block. In children especially in Indian population, the studies that have been done are very limited. This study that mainly focusing on pediatric population might be helpful to assess whether PI can be applied to detect the onset and adequacy of caudal block under GA similar to adults. Hence in this study we tried to compare the role of PI, HR and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

 
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