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Completed

NCT Number: NCT06712394

Knee Osteoarthritis and IPACK

Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.

The purpose of the study; To investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice.

In this study, patients who underwent IPACK block by the practitioner; Demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. Before and after the block procedure, patients' pain was measured with the Numeric Rating Scale (NRS) at 1st and 3rd months, their disability levels were measured with The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Short Form-12 (Short Form). Quality of life will be measured with the -SF-12) survey.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University

Adapazarı, Sakarya, 54010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from grade 3 and 4 knee osteoarthritis

Exclusion criteria

  • Patients who have had previous knee surgery
  • Patients who have had any knee injection in the last 3 months
  • Malignancy
  • Inflammatory disease
  • Infectious disease (local or general)

Treatment and study plan

IPACK

Procedure

The IPACK block involves infiltration of the space between the popliteal artery and the posterior knee joint capsule with 20 ml of 0.25% local anesthetic (bupivacain) under ultrasound guidance.

Primary outcomes

  1. Pain assessment

    Time frame: 1st and 3rd month after the procedure

    The Numeric Rating Scale (NRS) is a frequently used tool for assessing and monitoring the severity of pain. The pain scale measures on an 11-point rating system, where 0 indicates the absence of pain and 10 represents the most severe pain one can imagine. Patients are requested to assess their pain on a scale ranging from 0 to 10. The physician obtained from measurements at each visit by directly questioning the patient.

  2. Functional status

    Time frame: 1st and 3rd month after the procedure

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The questionnaire evaluates activities of daily living and functional mobility. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Secondary outcomes

  1. Quality of life assessment

    Time frame: 1st and 3rd month after the procedure

    The assessment of quality of life was conducted using the SF-12, a questionnaire specifically designed to measure health-related quality of life. The SF-12 consists of twelve items that evaluate eight different health domains, providing an evaluation of both physical and mental well-being. The SF-12 provides two summary scores: the mental component score (MCS-12) and the physical component score (PCS-12). A decrease in the questionnaire score indicates progression of disability. The questionnaire's validity and reliability were ensured, and the Turkish version of the questionnaire was filled out by the patients.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Interspace Between the Popliteal Artery and Capsule of the Posterior Knee-

Acronym: IPACK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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