| CTRI Number |
CTRI/2018/05/014091 [Registered on: 24/05/2018] Trial Registered Prospectively |
| Last Modified On: |
23/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Treatment for pain, nausea vommitting and ambulation post Total knee arthroplasty surgery |
|
Scientific Title of Study
|
Impact of clinical pathway on the postoperative outcome of patients for Total Knee Arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Dr. Lakhumal Hiranand Hiranandani Hospital
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Dr. Lakhumal Hiranand Hiranandani Hospital
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenoti Potdar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Dr. Lakhumal Hiranand Hiranandani Hospital |
| Address |
Dr. Lakhumal Hiranand Hiranandani Hospital
Department of Anaesthesia,
Hiranandani Gardens, Hillside Avenue, Powai
Hiranandani Gardens, Hillside Avenue, Powai
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
9920627839 |
| Fax |
|
| Email |
meenoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr L H Hiranandani Hospital
Hillside Avenue,
Hiranandani Gardens
Powai
Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr L H Hiranandani Hospital |
| Address |
Hillside Avenue,
Hiranandani Gardens
Powai
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 Meenoti Potdar |
Operation Theatre recovery room and wards |
Dr L H Hiranandani Hospital Hillside Avenue
Hiranandani Gardens Powai Mumbai
2nd floor - Operation theatre recovery room
4th, 5th, 9th, 10,th and 11th floor -wards
Mumbai (Suburban)
MAHARASHTRA |
9920627839
meenoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr L H Hiranandani Hospital Powai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1, 2 and 3 patients clinically fit undergoing elective TKA surgery , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1to 3 patients electively posted for total knee arthtroplasty surgery
2. Total Knee arthroplasty under combined spinal epidural anaesthesia
3. POst operative management as per the clinical pathway protocols set
4. patients willing to be enrolled under clinical pathway protocols |
|
| ExclusionCriteria |
| Details |
1. ASA4 patints who would require post operative intensive care monitoring.
2. Patients operated by orthopaedic surgeons other than the full time consultants of the hospital
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To link evidence to practice and optimize clinical outcomes while maximizing clinical efficiency.
1.Nausea vomitting postoperatively
2.Early Feeding post operatively
3. Ambulation and rehabilitation of patients
4. Post operative analgesia
5. Numbness uring post operative period
|
1.Nausea vomitting postoperatively -immediate recovery room till day of discharge from hospital
2.Early Feeding post operatively- immediate post operatively in the recovery room till 6 hours
3. Ambulation and rehabilitation of patients Post poeratively from 6 hours till day of discharge
4. Post operative analgesia - from recovery room till day of discharge
5. Numbness during post operative period- during ambulation postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
Length of hospital stay- Day of discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| 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="8"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical Pathways (CP) or Integrated care pathways are defined as structured multidisciplinary care plans which detail essential steps in the care of patients with a specific clinical problem.
Aims To link evidence to practice and optimize clinical outcomes while maximizing clinical efficiency.
Introduced in our hospital in 2011 for Total knee Arthroplasty TKA is a complex surgery whose functional outcome depends on early mobilization which indirectly depends on good post operative pain relief We introduced CP for TKA to streamline the post operative course for optimising rehabilitation Better pain relief minimising the side effects.
|