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
|
|
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
|
|
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
|
|
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 |