| CTRI Number |
CTRI/2024/10/075649 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of relief of post-operative pain by measuring BP, heart rate in post operative period |
|
Scientific Title of Study
|
Evaluation of the role of PERFUSION INDEX as an indicator of objective assessment of pain relief in the Post-Operative period- A Prospective Observational Study. |
| 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 Bhavna Saxena |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay, Hospital |
| Address |
Department of Anesthesiology
Deen Dayal Upadhyay Hospital
Harinagar
New Delhi
India
West
DELHI
110064
India |
| Phone |
9718990124 |
| Fax |
|
| Email |
drbhavnasaxena2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Saxena |
| Designation |
Senior Medical Officer |
| Affiliation |
Deen Dayal Upadhyay, Hospital |
| Address |
Department of Anesthesiology
Deen Dayal Upadhyay Hospital
Harinagar
New Delhi
India
West
DELHI
110064
India |
| Phone |
9718990124 |
| Fax |
|
| Email |
drbhavnasaxena2109@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehraj ud din Bhat |
| Designation |
DNB resident (secondary) |
| Affiliation |
Deen Dayal Upadhyay Hospital |
| Address |
Pain clinic
2nd floor, OT complex
Department of Anesthesiology
Deen Dayal Upadhyay Hospital
Harinagar
New Delhi
India
West
DELHI
110064
India |
| Phone |
7889395584 |
| Fax |
|
| Email |
mehraj392@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deen Dayal Upadhyay Hospital
Harinagar
Delhi
110064 |
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Harinagar
New Delhi
110064 |
| 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 Mehraj ud din bhat |
Deen Dayal Upadhyay Hospital |
Deen Dayal Upadhyay Hospital
Main Operation Theatre
2nd floor
Department of anesthesiology
Deen Dayal Upadhyay Hospital
Harinagar
110064
West
DELHI |
7889395584
mehraj392@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Deen Dayal Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I,II
Patients in immediate post-operative period who underwent elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients unable to communicate and cooperate
Hemodynamically unstable patients
Pre existing cardiac disease, neurological problems and peripheral occlusive atery disease
Patient with COPD and bronchial asthma
Infections of hand
Patients with history of psychiatric illness and chronic pain disorder
Patients with fever or hypothermia
History of drug allergy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate PI and VAS scores before and after use of analgesics for pain relief in the post-operative period |
T0- immediate post-operative period
T1- time of first request for analgesia
T2- 30 min after analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate PI with hemodynamic parameters before and after the use of analgesics for pain relief in the post-operative period |
T0- immediate post-operative period
T1- at the time of first request for analgesia
T2- 30 min after analgesia |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/10/2024 |
| 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="0"
Months="6"
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
|
It is a prospective observational study to study the role of perfusion index as an indicator of objective assessment of pain relief by giving injection diclofenac sodium 1.5 mg/kg IV in the post-operative period. Here the patients of 18-60 years of age undergoing elective surgery under general anesthesia will be assessed in the immediate post-opeeative period(T0), then patients with be assessed at T1- time of first request for analgesia and then reassessed at T2 - 30 min after recieving analgesia. The PI ,VAS scores and hemodynamic parameters (MAP, SBP, DBP, HR) with be measured and compared. |