| CTRI Number |
CTRI/2024/11/076600 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing the efficacy of Abive knee Nerve Block with injection in the back in providing post operative pain releif and early ambulation in patients undergoing total knee replacement. |
|
Scientific Title of Study
|
Comparison of Ultrasound- Guided Continuous Adductor canal Block-iPACK(Infiltration between the popliteal artery and capsule of the knee)Block with Epidural analgesia on Functional Recovery in Patients Undergoing Total knee Arthroplasty - A Randomised Controll |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pon Sushma |
| Designation |
Post Graduate MD Anaesthesiology |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd floor SRM Medical college and research hospital
Kattangulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
dr.ponsushma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Anand |
| Designation |
Professor |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd floor SRM Medical college and research hospital Kanchipuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Anand |
| Designation |
Professor |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Room No 208 B Block Dept of Anaesthesiology 2nd floor SRM Medical college and research hospital Kanchipuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre Kattangulathur Kanchipuram
Tamil Nadu
603203
India |
|
|
Primary Sponsor
|
| Name |
SRM Medical college |
| Address |
Room No 209 B Block 2nd floor Department of Anesthesiology SRM Medical college Hospital and Research centre Kattangulathur Kanchipuram Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Pon Sushma |
SRM institute of Science and technology |
Room No 209 B Block 2nd floor Department of Anesthesiology SRM Medical college Hospital and Research centre Kattangulathur Kanchipuram
Kancheepuram
TAMIL NADU |
7357378949
dr.ponsushma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee -Students |
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: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous Epidural infusion post operatively |
0.2% Ropivacaine at 6 ml per hour post operatively |
| Intervention |
Ultrasound guided Continuous adductor canal block ,IPACK block |
0.2% Ropivacaine at 6 ml per hour post operatively
IPACK BLOCK given using 0.5% Ropivacaine 20 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiology criteria 1 2 and 3 patients |
|
| ExclusionCriteria |
| Details |
Patients refusing consent
Revision Total knee arthroplasty patients
Severe cardiac and renal illness
Body mass index more than 25
Cellulitis infection at local site coagulopathy allergy to local anaethetic agents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare functional recovery in both groups using TUG score. |
To compare functional recovery in both groups using TUG score
at 24 hours and 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score
|
12hours and 24 hours |
| Blood loss |
24hrs |
| Patients requiring catheterization |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
22/11/2024 |
| 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="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
|
We hypothesize that the functional recovery in post Total knee arthroplasty patients who receive Continuous adductor canal block with IPACK block is better than in patients who receive continuous epidural infusion as measured with the TUG score. The visual analogue score , post operative urinary retention and blood loss are the secondary objectives rephrased to focus on improvement. |