| CTRI Number |
CTRI/2025/11/098101 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of iPACK block versus local infiltration analgesia for total knee arthroplasty |
|
Scientific Title of Study
|
Comparison of the role of the iPACK Interspace between the Popliteal Artery and the Capsule of the Posterior Knee block versus local infiltration analgesia as part of a multimodal regimen for total knee arthroplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NiIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Shantesh Kaushik |
| Designation |
Consultant anaesthesiology |
| Affiliation |
Wockhardt Hospitals |
| Address |
Department of Anesthesia, 11th floor, Wockhardt Hospital, Mumbai Central
Mumbai
MAHARASHTRA
400011
India |
| Phone |
9820335085 |
| Fax |
|
| Email |
ap.kshik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farha Tarig Sed Ahmed |
| Designation |
Resident (Primary DNB) |
| Affiliation |
Wockhardt Hospitals |
| Address |
Department of Anesthesia, 11th floor, Wockhardt Hospital, Mumbai Central
Mumbai
MAHARASHTRA
400011
India |
| Phone |
9372323813 |
| Fax |
|
| Email |
farhatarig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farha Tarig Sed Ahmed |
| Designation |
Resident (Primary DNB) |
| Affiliation |
Wockhardt Hospitals |
| Address |
Department of Anesthesia, 11th floor, Wockhardt Hospital, Mumbai Central
MAHARASHTRA
400011
India |
| Phone |
9372323813 |
| Fax |
|
| Email |
farhatarig@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aparna Shantesh Kaushik |
| Address |
Department of Anaethesiology, Wockhardt Hospitals, 1877, Dr. Anand Rao Nair Road, Near Agripada Police Station, Mumbai Central (E), Mumbai -400011 |
| Type of Sponsor |
Other [] |
|
|
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 Farha Tarig Sed Ahmed |
Wockhardt Hospitals |
Police Station,1877, Dr Anandrao Nair Marg, near Agripada, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA |
9372323813
farhatarig@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Wockhardt Hospitals Institutional Review Board |
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: M238||Other internal derangements of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
iPACK (interspace between popliteal artery and the capsule of the posterior knee |
20 ml of 0.2% Ropivacaine administered under ultrasound guidance as a single intervention before the start of the surgery
Intervention time is 15 minutes |
| Comparator Agent |
Local infiltration analgesia at the posterior capsule |
20ml of 0.75% Ropivacaine, 30mg of Traiamcinolone, 30mg of Ketorolac, 75mcg of Clonidine, 100mcg of Epinephrine diluted in Normal Saline to make a total of 40ml of infiltration solution which is injected after the bony resections into the synovium, medial and lateral retinacula, surrounding muscles and subcutaneous tissues. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 undergoing elective unilateral total knee replacement under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate
2. Patient refusal for spinal anaesthesia
3.any contraindications for spinal anaesthesia
4. Coagulopathy or bleeding disorders
5.infection or injury at the site of block administration
6.history of allergy to any local anaesthetic or adjuvants
7. Patients with peripheral neuropathy
8. Patients classified as ASA grade 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VAS Scores
2. Duration of analgesia
3. Requirement of rescue analgesia |
8 hour interval upto 48 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mobilization
Post-operative haemodynamics
Any adverse effects |
8 hour interval upto 48 hours post operatively |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/12/2025 |
| 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="0"
Months="11"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [farhatarig@gmail.com].
- For how long will this data be available start date provided 14-11-2025 and end date provided 13-11-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Total knee arthroplasty (TKA), or total knee replacement, is a frequently performed surgical procedure associated with significant postoperative pain that has the potential to delay mobilization, reduce patient satisfaction, and contribute to development of chronic pain if inadequately controlled. With an aging population, the expected rise in TKA procedures underscores the need for optimized multimodal analgesia that provides optimal analgesia while facilitating early mobility. Pain management strategies for TKA include: 1. Neuraxial techniques (e.g. epidural analgesia) 2. Peripheral nerve blocks (e.g. femoral nerve block, adductor canal block [ACB], the iPACK block) 3. Local techniques (e.g. local infiltration analgesia [LIA], intra - articular catheters) These are typically combined with systemic analgesics to form comprehensive multimodal regimens. Motor - sparing peripheral techniques - especially ACB and iPACK - are emphasized within Enhanced Recovery After Surgery (ERAS) pathways, as they allow early ambulation with minimal quadriceps impairement. This study looks at three techniques: Local infiltration analgesia (LIA), the adductor canal and the iPACK block. |