The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty
The Effect of Distal Versus Proximal Approach to the Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee (iPACK) on Pain After Total Knee Arthroplasty
Comenius University
120 participants
Feb 12, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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
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Interventions
● In the distal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the most distal part of the thigh, between the femoral condyles.
● In the proximal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the level of the distal femoral shaft (a straight portion of the femur without the condyles).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07080892