NCT07080892 The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty
| NCT ID | NCT07080892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comenius University |
| Condition | Postoperative Pain Following Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-02-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07080892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Postoperative Pain Following Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07080892 currently recruiting?
Yes, NCT07080892 is actively recruiting participants. Contact the research team at danoandreas@gmail.com for enrollment information.
Where is the NCT07080892 trial being conducted?
This trial is being conducted at Bratislava, Slovakia.
Who is sponsoring the NCT07080892 clinical trial?
NCT07080892 is sponsored by Comenius University. The trial plans to enroll 120 participants.