NLR and PLR Levels Following iPACK Block in Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

The Neutrophil-to-lymphocyte Ratio (NLR) and Platelet-to-lymphocyte Ratio (PLR) Levels Following iPACK Block in Knee Arthroplasty: a Randomized, Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304298
• Other study ID #: 10/2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of iPACK block on NLR and PLR following knee arthroplasty

Description:

The NLR is a sensitive indicator of inflammation confirmed in numerous studies and has a predictive and prognostic value. NLR is a cheap, simple, fast-acting, readily available stress and inflammation parameter with high sensitivity and low specificity. Dynamic changes in the NLR precede the clinical state for several hours and may alert clinicians early about the ongoing pathological process. NLR is a new promising marker of cellular immune activation, an important indicator of stress and systemic inflammation. It opens a new dimension for clinical medicine to understand better the biology of inflammation, the linkage, and antagonism between innate and adaptive immunity, and its clinical consequences for health and disease. NLR is affected not only by surgical trauma but also by the method of anesthesia. In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, there have been very few studies evaluating the effect of various methods of anesthesia on the NLR. This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing knee replacement surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with ASA classification I-III
• Aged 20-90 years
• Who will be scheduled for hip arthroplasty under spinal anesthesia

Exclusion Criteria:

• Patients who have a history of bleeding diathesis
• Take anticoagulant therapy
• History of chronic pain before surgery
• Multiple trauma
• patients unable to assess their pain (dementia)
• patients operated under general anesthesia
• patients having an infection in region of the procedure
• patient who do not accept the procedure

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 0.9% Sodium Chloride Injection
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride
• Ropivacaine 0.2% Injectable Solution
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophil-to-lymphocyte ratio	Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.	12 hours after surgery
Primary	Neutrophil-to-lymphocyte ratio	Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.	24 hours after surgery
Primary	Neutrophil-to-lymphocyte ratio	Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.	48 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	12 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	24 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	48 hours after surgery
Secondary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
Secondary	Opioid Consumption	Total opiate consumption after surgery	48 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	4 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	8 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	12 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	18 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	24 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	36 hours after surgery
Secondary	Pain score	NRS (Numerical Rating Scale)	48 hours after surgery