- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712394
Knee Osteoarthritis and IPACK (IPACK)
Interspace Between the Popliteal Artery and Capsule of the Posterior Knee-
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sakarya
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Adapazarı, Sakarya, Turkey (Türkiye), 54010
- Sakarya University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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IPACK
IPACK block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment
Time Frame: 1st and 3rd month after the procedure
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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.
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1st and 3rd month after the procedure
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Functional status
Time Frame: 1st and 3rd month after the procedure
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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.
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1st and 3rd month after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life assessment
Time Frame: 1st and 3rd month after the procedure
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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.
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1st and 3rd month after the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Rıdvan Isık, sakarya training and research hospital, pain clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- isik eman ipack
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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