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CTRI Number  CTRI/2023/09/057736 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Priospective observational trial 
Study Design  Other 
Public Title of Study   A prospective observational study of pain assessment after operation for planned cancer surgery  
Scientific Title of Study   Utility of Perfusion index as a tool for assessment of Acute postoperative pain in elective oncosurgery: A PROSPECTIVE OBSERVATIONAL STUDY 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna Cahtterjee 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Critical Care and Pain Tata Memorial Hospital Mumbai Maharashtra India
NA
Mumbai
MAHARASHTRA
400012
India 
Phone  9322243936  
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Siddharaj Vaze 
Designation  Junior resident 2 
Affiliation  Tata memorial hospital 
Address  Department of Anaesthesiology Critical Care and Pain Tata Memorial Hospital Mumbai Maharashtra India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869937199  
Fax    
Email  sidvaze@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Siddharaj Vaze 
Designation  Junior resident 2 
Affiliation  Tata memorial hospital 
Address  Department of Anaesthesiology Critical Care and Pain Tata Memorial Hospital Mumbai Maharashtra India


MAHARASHTRA
400012
India 
Phone  9869937199  
Fax    
Email  sidvaze@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept of Anaesthesia, Critical care and Pain, Dr. E Borges Road,Parel, Mumbai 
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 Aparna Chatterjee  Tata memorial hospital  Dept of Anaesthesia Critical care and Pain Dr. E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA 
9322243936

aparnasanjay@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee  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, (2) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (3) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adults : Age 18–80 years
2. ASA 1 and 2
3. Patients posted for surface surgeries which include ,breast surgery ( without reconstruction) , orthopedic surgeries ,head and neck surgeries awake , non intubated patient
 
 
ExclusionCriteria 
Details  1. Severe cardiac disease (ischemic/valvular/failure related) which limit the functional activities of the patient, (above NYHA class 1)
2. History of chronic kidney disease, or current deranged renal functions,
3. History of liver disease, or current deranged liver functions,
4. Patients on preoperative opioids, both strong and weak opioids like Tramadol, codeine.
5. Patients with a history of a neurological, psychiatric, disorder, who were taking psychotropic drugs
6. Patients with allergy to any drug used in the study.
7. Postoperative unstable hemodynamic status, or on ventilator support
8. Patient who have received intraoperative regional analgesia (Epidural/regional blocks)
9. Patients on anti hypertensive(NTG ) / Dexmedetomidine infusion
10. Patients with blood loss more than 1 litre.
11. Postoperative temperature less than 35 degree Celsius or 95 F
12. Surgeries which lasted for more than 3 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish correlation between NRS score and PI or delta PI in PACU patients undergoing surface surgeries at a tertiary cancer care hospital.
To analyse the trend of perfusion index with pain score  
The PI will be recorded every 30 mins after admission to recovery room at the time of the first request for analgesia At the time of the first request for analgesia NRS for pain intensity will be recorded 
 
Secondary Outcome  
Outcome  TimePoints 
- To analyse the trend of perfusion index with pain score  Thirty minutes after postoperative analgesia, second measurements of the above-mentioned parameters will be taken simultaneously. (NRS for pain intensity, PI, HR, MAP, peripheral oxygen saturation, & axillary temperature.) 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   25/09/2023 
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  

Pain after cancer surgeries procedures can be severe. Pain management is based on a subjective criterion, and works best when patient is able to understand and communicate his level of pain. The adequacy of analgesic administered is also decided according to improvement in the subjective parameters which may vary from person to person. These variations are difficult to standardise. Hence objective criteria to guide pain management may be of certain help as an adjunct to the subjective criterion. Perfusion index is a parameter obtained non-invasively by a pulse oximeter probe. (Probe attached to a finger that gives a reading of level of oxygen on monitor) Perfusion index may be used as a objective criteria for pain assessment.

If you agree to participate in the study, the following which will be monitored ( HR, blood pressure ,oxygen saturation and perfusion index) during your stay in the recovery room, post surgery,  as per standard of care, will be recorded for study purpose. All the above parameters will be noted half hourly for 2 hours in recovery room. Pain scores (NRS) will be noted hourly. Whenever patient has moderate to severe pain rescue pain killer (injection tramadol) will be given. The parameters (HR, BP, Perfusion index, oxygen saturation, and temperature) will be noted prior to administration of pain killer and 30 minutes after the administration of pain killer. The change in perfusion index as well as its correlation with pain scores will be noted

 
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