| CTRI Number |
CTRI/2026/01/101953 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
iPACK block in chronic knee pain. |
|
Scientific Title of Study
|
Role of iPACK ( Infiltration between popletial artery and capsule of knee ) in chronic knee pain. |
| 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 Kritika Khanduri |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences (IMS), Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR Pradesh
221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7895606573 |
| Fax |
|
| Email |
kritikakhanduriz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Prakash |
| Designation |
Professor |
| Affiliation |
Institue of Medical Sciences (IMS), Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences (IMS), Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453047154 |
| Fax |
|
| Email |
dr.shashi.prakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Institute (IMS), Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences (IMS), Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765514029 |
| Fax |
|
| Email |
dr.sumita.1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institue of Medical Sceinces, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences (IMS), Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS), Banaras Hindu University (BHU) |
| Type of Sponsor |
Government 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 |
| Dr Kritika Khanduri |
Institute of Medical Sciences, Banaras Hindu University |
Department of Anaesthesiology, Institute of Medical Sciences(IMS), Banaras Hindu Unviersity(BHU)
Varanasi
UTTAR PRADESH |
77895606573
kritikakhanduriz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMITTEE |
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 |
iPACK (Infiltration between popletial artery and capsule of knee) block |
Group I - Patients that will recieve iPACK block with 10 ml of 0.2% Ropivacaine and 20mg of Triamcinolone |
| Comparator Agent |
Placebo |
Group P - Patients will recieve normal saliine as placebo |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients with knee pain of more than 3 month duration.
2-Patients aged 35 - 70 years.
3-Patients with posterior knee pain.
4-Informed consent obtained from patient .
5-Paitients with ASA grade 1-3.
|
|
| ExclusionCriteria |
| Details |
1-Patients with knee pain due to any lumbo - sacral spine pathology.
2- Patients with previous history of tibial or femoral fracture.
3- Patients with BMI more than 30 kg/metre suqare.
4- Patients with history of any infection or inflammation.
5- Patients who are allergic to local anaesthetic drugs.
6-Patients who decline to provide consent or withdraw from study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the effect of iPACK block on pain score - Numerical Rating Scale (NRS ) Score. |
1. Before the procedure.
2. 2 hours after the procedure.
3. 7 days after the procedure.
4. 15 days after the procedure.
5. 30 days after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluate the effect of iPACK on functional recovery of the patient - Western Ontario and McMaster Universities Osteoarthritis Index( WOMAC Score ).
2. Monitor complications (motor weakness, sensory loss) that may occur during and after the procedure. |
1. Before the procedure.
2. 2 hours after the procedure.
3. 7 days after the procedure.
4. 15 days after the procedure.
5. 30 days after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
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 [kritikakhanduriz@gmail.com].
- For how long will this data be available start date provided 28-01-2026 and end date provided 28-01-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
We will divide patients into two groups - 1. Group I -Patients that will recieve iPACK block for knee pain. 2. Group P -Patients that will recieve placebo (Normal saline).
We will start with baseline work up of the patient. It will include- Proper history of the patient. Baseline investigations ( Complete blood counts, Viral markers, Liver function test , Renal function test). After baseline workup, patient is taken to pain OT. We secure intravenous canula, monitor blood pressure , ECG , and Sp02 during the procedure.
• Group I - For the patient recieving iPACK block, the pt is kept in prone position, a 6-15 MHz high frequency linear transducer is kept at the medial part of knee. The probe was moved from cranial to caudal direction until the two heads of the gastrocnemius muscle were visualized.We then identify the popletial artery. At this plane the stimuplex needle (10 centimetre) is advanced in lateral to medial direction using an in-plane approach until the needle tip was located between the popletial artery and the capsule of knee. The drug is then given in this plane. We give 10 ml of 0.2 % Ropivacaine with 20 mg Triamcinolone.
• Group P- For the second group, we will give normal saline as a placebo.
We will also observe for any adverse effects and complications during and after the procedure. We will observe the patient for 2 hours after the procedure, and the patient will be discharged on the same day.
Patient will be given following advice on discharge - 1. Keep cold compression on the knee for 3 hours after the procedure. 2. Avoid brisk walking , increasing load on knee, and performing heavy strenuous exercise of the knee for a week after the procedure. 3. Tell the patient to come for follow up a week after the procedure. 4. Patient will be given aceclofenac + paracetamol tablet as a rescue drug, and will be asked to take the tablet if NRS score is more than 4 at anytime . We will also note how many times the patient took rescue drugs.
The parameters that we will study are - 1. NRS Score . 2. WOMAC Score. 3. Motor weakness.
The parameters will be compared at following time points- 1. Before the procedure. 2. 2 hours after the procedure. 3. 7 days after the procedure. 4. 15 days after the procedure. 5. 30 days after the procedure.
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