Distal versus proximal iPACK for pain control after total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a double-blind, randomized controlled design, 120 adults undergoing primary unilateral total knee arthroplasty for osteoarthritis will receive either a distal iPACK (between the femoral condyles) or a proximal iPACK (at the distal femoral shaft) as part of perioperative analgesia. Pain scores at rest and on movement, opioid consumption, and time to first rescue analgesia will be recorded, together with measures of motor function and recovery. The iPACK targets the posterior knee capsule to provide analgesia while sparing major motor nerves, and investigators hypothesize the distal injection may better cover posterior innervation. Standardized anesthesia and postoperative care protocols will be used and patients with contraindications to regional anesthesia or non-osteoarthritis diagnoses are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 80 years
* Patients undergoing primary unilateral total knee arthroplasty (TKA) 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 (e.g., VAS)

Exclusion Criteria:

* Refusal to participate or failure to sign informed consent
* Bilateral or revision TKA
* Partial or unicondylar knee replacement
* Severe knee deformity (flexion, varus, or valgus \>30°)
* Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, septic arthritis, post-traumatic arthritis)
* Allergy to local anesthetics or any medications used in the study
* Contraindications to regional anesthesia (e.g., infection at the injection site, coagulopathy, therapeutic anticoagulation)
* BMI \> 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 VAS
* Planned outpatient (same-day discharge) procedure

Where it's running

• 1st Department of Anaesthesiology and Intensive Care Medicine
  Bratislava, Slovakia Recruiting

Study contacts

• Study coordinator: Andrej Dano, MD
• Email: danoandreas@gmail.com
• Phone: +421911571616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.