| CTRI Number |
CTRI/2025/04/083775 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects between two comparison groups planned to undergo replacement of knee joint based on post operative pain and early rehabilitation one group receiving epidural analgesia and intervention group receiving regional anaesthesia with adductor canal block and IPACK block |
|
Scientific Title of Study
|
Effects of Adductor canal block combined with infiltration between the popliteal artery and capsule of the knee on pain management compared with epidural analgesia for patients undergoing total knee arthroplasty a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjot Multani |
| Designation |
PG resident |
| Affiliation |
Armed forces medical college, |
| Address |
dept of anaesthesia and citical care, Armed forces medical college, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9988265487 |
| Fax |
|
| Email |
drmanjotmultani1211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig Rahul Yadav |
| Designation |
head of department |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
dept of anaesthesia and citical care, Armed forces medical college, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjot Multani |
| Designation |
PG resident |
| Affiliation |
Armed forces medical college, |
| Address |
dept of anaesthesia and citical care, Armed forces medical college, Pune
MAHARASHTRA
411040
India |
| Phone |
9988265487 |
| Fax |
|
| Email |
drmanjotmultani1211@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College Pune, Maharashtra, India
pincode: 411040 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College Pune |
| Address |
armed forces medical college pune, maharashta, india
pincode 411040 |
| 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 |
| manjot multani |
Armed forces medical college |
dept of anaesthesia and citical care, Armed forces medical college, Pune
Pune
MAHARASHTRA |
09988265487
drmanjotmultani1211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adductor canal block with infiltration between the popliteal artery and capsule of the knee |
20 ml of 0.25% bupivacaine for adductor canal block and 15ml of 0.25% bupivacaine for IPACK block will be given Ultrasound guided |
| Comparator Agent |
Epidural Analgesia |
CSEA will be performed at L3-L4 or L4-L5 position and catheter to be inserted which will have continous infusion at 5ml/hr of 0.125% bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 to 3
body mass indexes between 18 to 40 kg/m2
fully oriented and cooperative |
|
| ExclusionCriteria |
| Details |
refusal to participate
any contraindication to neuraxial anaesthesia
lower extremity neuropathy
local anaesthetic allergy
revision surgery
advanced liver, heart, kidney failure
inability to comprehend VAS score
cognitive impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the visual analogue scale VAS of the patients at postoperative 8th hour during passive physical therapy movements |
VAS of the patients at postoperative 8th hour during passive physical therapy movements |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare VAS score of the patients at 1st postoperative day and 2nd postoperative day during active and passive physical therapy movements
2. to compare 25M ambulation times on POD1
3. to compare opioid consumption in postoperative POD1 and POD2 |
POD 1 and POD 2 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
01/04/2025 |
| 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 Applicable |
| 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
|
Total knee arthroplasty is regarded as one of the most painful orthopaedic operations. Adequate pain relief is essential in the immediate postoperative period to enable ambulation, initiation of physiotherapy, prevention of postoperative complications. A variety of procedures are currently being employed to achieve the same including neuraxial anaesthesia and regional anaesthesia including Adductor canal block. However, ACB does not relieve posterior knee pain and hence the addition of IPACK block ( infiltration between popliteal artery and capsule of the knee) has shown promising results in providing significant posterior knee analgesia without affecting motor nerves resulting in better range of motion and ambulation compared to adductor canal block alone |