Actively Recruiting
The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty
Led by Comenius University · Updated on 2026-02-04
120
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Total knee arthroplasty (TKA) often results in significant postoperative pain, which can hinder recovery despite advances in surgical and anesthetic techniques. Traditional pain management methods like femoral nerve blocks may impair motor function, delaying rehabilitation. The iPACK block, targeting the posterior knee without affecting motor control, offers a promising alternative. This study aims to compare the effectiveness of two iPACK block approaches-proximal (at the distal femoral shaft) and distal (between the femoral condyles)-in managing postoperative pain in TKA patients. In a double-blind, randomized controlled trial with 120 participants, pain scores, opioid use, and time to rescue analgesia will be assessed. The hypothesis is that the distal iPACK block provides superior pain relief, potentially improving patient outcomes and recovery.
CONDITIONS
Official Title
The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis
- Ability to understand and sign informed consent
- American Society of Anesthesiologists (ASA) classification I-III
- Ability to cooperate and participate in postoperative pain assessments such as VAS
You will not qualify if you...
- Refusal to participate or failure to sign informed consent
- Bilateral or revision total knee arthroplasty
- Partial or unicondylar knee replacement
- Severe knee deformity (flexion, varus, or valgus >30 degrees)
- Diagnosis other than osteoarthritis such as rheumatoid arthritis, septic arthritis, or post-traumatic arthritis
- Allergy to local anesthetics or any medications used in the study
- Contraindications to regional anesthesia such as infection at injection site, coagulopathy, or therapeutic anticoagulation
- Body mass index greater than 40 kg/m2
- Severe renal impairment (KDIGO stage G4 or higher) or liver failure (Child-Pugh score ≥ 10)
- Prior surgery or vascular procedure on the femoral vessels of the operated limb
- Language barrier or inability to assess pain using the Visual Analogue Scale
- Planned outpatient (same-day discharge) procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
1st Department of Anaesthesiology and Intensive Care Medicine
Bratislava, Slovakia, 82101
Actively Recruiting
Research Team
A
Andrej Dano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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