Knee Osteoarthritis and IPACK

NCT06712394 | Not Yet Recruiting

• 1 other identifier: isik eman ipack
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Pain assessment

  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.

  1st and 3rd month after the procedure

• Functional status

  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.

  1st and 3rd month after the procedure

Secondary Outcomes (1)

• Quality of life assessment

  1st and 3rd month after the procedure

Study Arms (1)

IPACK

IPACK block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.

Procedure: IPACK

Interventions

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.

IPACK

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 50-90 who underwent IPACK block treatment due to Knee OA

You may qualify if:

• Patients suffering from grade 3 and 4 knee osteoarthritis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sakarya University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rıdvan Isık

  sakarya training and research hospital, pain clinic

  STUDY CHAIR

Central Study Contacts

Ali eman

CONTACT

+905325152816; dralieman02@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11