| CTRI Number |
CTRI/2024/08/072745 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Different Approaches to Pain Management during Surgeries that Involve Changing Damaged parts of the knee joint at a specialty Hospital |
|
Scientific Title of Study
|
Various practice patterns in perioperative pain management in Total Knee Replacement in tertiary care hospital |
| 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 Arya K Ramesh |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College ,Manipal |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, Kasturba Medical College, Manipal Academy of Higher Education, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
7907165518 |
| Fax |
|
| Email |
aryakramesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Kini |
| Designation |
Associate Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, Kasturba Medical College, Manipal Academy of Higher Education, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
priyanka.kini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Kini |
| Designation |
Associate Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, Kasturba Medical College, Manipal Academy of Higher Education, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845801588 |
| Fax |
|
| Email |
priyanka.kini@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Trauma Operation Theatre Complex and post-operative care Unit,Udupi,Karnataka |
|
|
Primary Sponsor
|
| Name |
DR ARYA K RAMESH |
| Address |
JUNIOR RESIDENT,DEPARTMENT OF ANAESTHESIOLOGY,KASTURBA MEDICAL COLLEGE,MANIPAL ACADEMY OF HIGHER EDUCATION,UDUPI, KARNATAKA-576104 |
| Type of Sponsor |
Other [DR ARYA K RAMESH] |
|
|
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 Arya K Ramesh |
Kasturba Medical College , Manipal |
DEPARTMENT OF ANAESTHESIOLOGY,OT COMPLEX,KASTURBA MEDICAL COLLEGE,MANIPAL ACADEMY OF HIGHER EDUCATION,UDUPI, KARNATAKA-576104
Udupi
KARNATAKA |
7907165518
aryakramesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College And Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all total knee replacement surgeries in both male and female patients within the age limit of 30-99 years |
|
| ExclusionCriteria |
| Details |
patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe various practice patterns in perioperative pain management of elective Total Knee Replacement done in right setting with vigilant monitoring in a tertiary care hospital
|
Visual Analogue Scale at 6 Hours and 24 Hours
Time required to ask for the first analgesic
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To note the patient satisfaction in pain management
-To note the multimodal approach to perioperative pain
management
|
Visual Analogue Scale at 6 Hours & 24 Hours
Time required to ask for the first analgesic
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
27/08/2024 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Total Knee Replacement [TKR] is one of the most common surgeries performed to relieve joint pain in patients with osteoarthritis and degenerative disease of the knee.Postoperative pain in TKR restricts the early ambulation and range of motion there by risking thromboembolism. Multimodal approach to pain management are made and studied for the optimal result .This is an observational study where the pain score is noted before, during, after the surgery and at the time of discharge. Also noting the pain management practices which is useful in early ambulation and patient satisfaction. |