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CTRI Number  CTRI/2025/03/081876 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Assessing Pain in critically ill patients by the evaluation of Perfusion Index derived by oximetry in postoperative patients admitted in surgical ICU. 
Scientific Title of Study   Assessing pain in critically ill patients by the evaluation of Perfusion Index on postoperative patients admitted to the surgical ICU at the Department of Anaesthesiology and Critical Care, AIIMS, Nagpur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshay Rana 
Designation  junior resident 
Affiliation  Dept of Anaesthesiology and Critical care Aiims Nagpur 
Address  1st floor, OT Complex, Dept of Anaesthesiology and Critical care Aiims Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  8813091700  
Fax    
Email  lakshayrana1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sucheta Meshram 
Designation  Associate Professor 
Affiliation  Dept of Anaesthesiology and Critical Care AIIMS Nagpur 
Address  1st floor , OT Complex, Dept of Anaesthesiology and Critical care AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone    
Fax    
Email  sucheta1021@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sucheta Meshram 
Designation  Associate professor 
Affiliation  Dept of Anaesthesiology and Critical care AIIMS Nagpur 
Address  1st floor, OT Complex,Dept of Anaesthesiology and Critical care AIIMS Nagpur


MAHARASHTRA
441108
India 
Phone    
Fax    
Email  sucheta1021@aiimsnagpur.edu.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology & Critical Care, AIIMS Nagpur 
 
Primary Sponsor  
Name  AIIMS Nagpur 
Address  Department of Anaesthesiology and Critical Care AIIMS Nagpur Mihan 441108 
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 Lakshay Rana  AIIMS Nagpur  Department of Anaesthesiology and Critical Care AIIMS Nagpur Mihan 441108
Nagpur
MAHARASHTRA 
8813091700

lakshayrana1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Nagpur  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Postoperative adult patients admitted in the surgical ICU 
 
ExclusionCriteria 
Details  Amputed patients, patients with steep inotropic support, peripheral vascular disease and any factor affecting microcirculation in the limb shall be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the co-relation of perfusion index with pain levels.  at baseline (admission to ICU), 12 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/03/2025 
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 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 study aims to investigate the utility of the perfusion index (PI) as an objective tool for pain assessment in critically ill postoperative patients admitted to the surgical ICU. Pain management is a crucial component of care in such patients, but conventional methods like the Visual Analog Scale (VAS) and Behavioral Pain Scale-Non Intubated (BPS-NI) often have limitations due to the subjective nature of their measurements, especially in patients who are non-verbal or have altered mental status.

The perfusion index (PI), derived from photoplethysmography (PPG), offers a potential solution. It is a non-invasive method that measures peripheral blood flow, providing real-time data on the patient’s hemodynamic status. Since stress responses to pain can affect peripheral circulation, PI may serve as an indirect indicator of pain levels. This study will evaluate the correlation between PI and traditional pain scales, such as VAS and BPS-NI, to determine whether PI can provide a reliable and objective assessment of pain in critically ill patients. By establishing a correlation between PI and conventional pain metrics, the research aims to improve pain management strategies in the ICU, potentially leading to better patient outcomes, reduced complications, and enhanced comfort.

 
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