The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty

NCT07080892 | Recruiting

• 1 other identifier: UNB/RU/052025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain Following Knee Arthroplasty

Keywords

pain; postoperative pain; arthroplasty; peripheral nerve block; iPACK

Outcome Measures

Primary Outcomes (1)

• total opioids consumption

  total opioids consumption calculated to MME (morphine milligrams equivalent)

  from surgery until 24 hours after surgery

Secondary Outcomes (7)

• time to first opioid administration

  up to 24 hours after surgery

• Visual analog scale 6 (rest)

  6 hours postoperatively

• Visual analog scale 12 (rest)

  12 hours postoperatively

• Visual analog scale 24 (rest)

  24 hours postoperatively

• Visual analog scale 6 (flexion)

  6 hours postoperatively

Study Arms (2)

proximal iPACK group

EXPERIMENTAL

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).

Procedure: proximal iPACK

distal iPACK group

EXPERIMENTAL

In the distal iPACK group, the 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.

Procedure: distal iPACK

Interventions

distal iPACK PROCEDURE

● 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.

distal iPACK group

proximal iPACK PROCEDURE

● 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).

proximal iPACK group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

1st Department of Anaesthesiology and Intensive Care Medicine

Bratislava, 82101, Slovakia

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Andrej Dano, MD

CONTACT

+421911571616; danoandreas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)