| CTRI Number |
CTRI/2025/07/090666 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Better postoperative analgesic injection technique after knee surgeries |
|
Scientific Title of Study
|
Ultrasound-Guided 4-in-1 Block Versus Combined Genicular Nerve and iPACK Blocks for Postoperative Analgesia in Total Knee Arthroplasty: A Randomised Clinical 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 |
Pradeesh Johny T |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadai Veedu Medical College,Puducherry |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry - 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003549061 |
| Fax |
|
| Email |
pradeeshjohny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeesh Johny T |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadai Veedu Medical College,Puducherry |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry - 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003549061 |
| Fax |
|
| Email |
pradeeshjohny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeesh Johny T |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadai Veedu Medical College,Puducherry |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry - 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003549061 |
| Fax |
|
| Email |
pradeeshjohny@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pradeesh Johny |
| Address |
Department of Anaesthesiology,
Aarupadai Veedu Medical College,
Puducherry-607402,India |
| Type of Sponsor |
Other [self] |
|
|
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 Pradeesh Johny |
Aarupadai Veedu Medical College |
Department of Anaesthesiology,1st floor,A block
Pondicherry
PONDICHERRY |
9003549061
pradeeshjohny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC Institutional Human Ethical Commitee |
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 |
4 in 1 block |
30 ml of 0.25 percent bupivacaine with 8 mg dexamethasone will be given in mid thigh |
| Comparator Agent |
Genicular nerve block, iPACK block |
3o ml of 0.25 percent bupivacaine with 8 mg dexamethasone will be used for both genicular nerve and iPACK block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 and 3
BMI less than 30 |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Patients unwilling to enrol for the study
Change in the plan of anaesthesia
Patients with a history of allergy to the drugs used in the study
Patients with infection at the site of injection.
Chronic opioid use
Neuropathy
Bilateral TKR
Surgeries extending beyond 3 hours duration
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Analgesic efficacy of ultrasound-guided 4-in-1 Block versus ultrasound-guided genicular nerve block with iPACK block postoperatively for patients undergoing total knee arthroplasty, measured by the Visual Analogue Scale. |
Postoperatively at 2,4,6,12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the requirement of postoperative rescue analgesia |
End of surgery till 24 hours postoperatively |
| To assess the ease of the procedure in terms of duration |
From insertion of the needle till the needle is taken out after final injection |
| To evaluate the time to mobilisation postoperatively |
From end of surgery to the time when the patient walks first |
| To assess the incidence of complications like hematoma and nerve injury |
End of surgery till 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="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 - 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - If requested through email data will be shared - pradeeshjohny@gmail.com
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
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
|
Effective postoperative analgesia for total knee arthroplasty(TKA) requires addressing the complex innervation of knee joint. The femoral nerve innervates the anterior and medial aspects of the knee, and branches of the sciatic nerve innervate the posterior aspects of the knee capsule. The 4 in 1 block is a novel technique designed to anaesthetise the saphenous nerve, obturator nerve, nerve to vastus medialis, and sciatic nerve using a single injection, potentially offering complete analgesia for TKA. Infiltration between the popliteal artery and capsule of the knee(iPACK) block provides analgesia to the posterior compartment of the knee without causing any motor weakness, and the genicular nerve block targets the articular branches innervating the anterior, medial and superolateral aspects of the knee and has motor sparing effect. In this study, we hypothesise that 4 in 1 block would provide better postoperative analgesia after TKA compared to genicular nerve block with iPACK block.. |