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CTRI Number  CTRI/2025/03/082549 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Study to assess the need and type of pain killers analgesics prescribed at discharge for patients undergoing cancer surgery. 
Scientific Title of Study   Observational study to assess the need and pattern of analgesics prescribed at discharge for patients undergoing major cancer surgery. 
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 Sumitra Bakshi  
Designation  Professor  
Affiliation  Tata Memorial Hospital and Homi Bhabha Institute Mumbai. 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, 2nd floor, OT complex, Tata Memorial Hospital, Parel,Mumbai Mumbai MAHARASHTRA 4000012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumitra Bakshi  
Designation  Professor  
Affiliation  Tata Memorial Hospital and Homi Bhabha Institute Mumbai. 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, 2nd floor, OT complex, Tata Memorial Hospital, Parel,Mumbai Mumbai MAHARASHTRA 4000012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Vaibhav Patil 
Designation  PG student  
Affiliation  Tata Memorial Hospital and Homi Bhabha Institute Mumbai. 
Address  Tata Memorial Hospital Address Department of Anesthesia, Critical Care and Pain, Main Building, 2nd floor, OT complex, Tata Memorial Hospital, Parel,Mumbai Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177058  
Fax    
Email  vaibhavpatil13381@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai 400028, India.  
 
Primary Sponsor  
Name  Department of Anesthesia Critical Care and Pain  
Address  Main building, 2 nd floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400028, India  
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 Sumitra G Bakshi  Tata Memorial Hospital   Main Building, 2nd floor, OT complex, Tata Memorial Hospital, Parel, Mumbai 400028, India
Mumbai
MAHARASHTRA 		 02224177058

sumitrabakshi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients upto 80 years following major oncology surgery with discharge within 96 hours of surgery will be included. 
 
ExclusionCriteria 
Details  1. Refusal to participation.
2.Emergenecy surgeries.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total number of patients in moderate -severe pain a week after discharge from the hospital following major onco surgeries, assessed by analysing the severity of average pain recorded in the short form of Brief Pain Inventory ( BPI)   a week after discharge from the hospital  
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of patients (in percentage) advised round the clock analgesics at discharge, since evaluation will be done at end of a week – this assessment will be recorded for the first 2 days
2. The pattern of analgesic prescribed as number of analgesics from different sub types- opioid, PCM, NSAIDS, adjutants
3. Number of patients who still needed rescue analgesics at time of evaluation ( ie a week after surgery )
4. Number of patients who returned to the hospital for pain complains either to OPD / casualty
 		 One week after surgery 
5. Number of patients who did not take medications as advised
6. Number of patients who needed additional analgesics than prescribed in first week of surgery. The source of additional analgesics will also be noted as local doctor/ local dispensary /medications left over from previous prescriptions.
7. The association of pain scores, need for additional analgesics , will be correlated with various DMG to identify areas of improvement
 		 One week after surgery 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   28/03/2025 
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="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 - NO
Brief Summary  

After taking approval from Institutional ethics committee, 30 patients from each DMG (Thoracic, Gastrointestinal, Gynecology, Urology, Bone and soft tissue, Breast, and Head neck surgeries), and a total of 210 consecutive patients who are discharged within 96 hours of major surgery will be enrolled in the study after taking valid informed consent.

Based on the feedback from surgeons, patients planned for discharge within 96 hours will be consented. After consent, patient will be given hard copy of BPI and the scale will be explained to them.  The analgesics on discharge card will be noted. If the patients are asked to follow-up with in a week, then at first follow up or else telephonically, the pain assessment based on BPI will be done. In case patient has severe pain not being controlled by analgesic advised then a follow-up with the unit and if needed pain clinic will be advised.

 
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