NLR and PLR Levels Following IPACK Block in Knee Arthroplasty

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

Effect of iPACK block on NLR and PLR following knee arthroplasty

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthropathy; Knee Pain Chronic
• Intervention / Treatment: Drug: 0.9% Sodium Chloride Injection; Drug: Ropivacaine 0.2% Injectable Solution

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sham blocks; iPACK block with 20ml of 0.9% sodium chloride	Drug: 0.9% Sodium Chloride Injection; After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride; Other Names: Placebo
Active Comparator: iPACK block; iPACK block with 20ml 0f 0.2% ropivacaine	Drug: Ropivacaine 0.2% Injectable Solution; After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine; Other Names: iPACK block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours after procedure
PLR	Platelet-to-lymphocyte ratio	48 hours after surgery
PLR	Platelet-to-lymphocyte ratio	12 hours after surgery
PLR	Platelet-to-lymphocyte ratio	24 hours after surgery
Opioid Consumption	Total opiate consumption after surgery	48 hours after surgery
Pain score	NRS (Numerical Rating Scale)	4 hours after surgery
Pain score	NRS (Numerical Rating Scale)	8 hours after surgery
Pain score	NRS (Numerical Rating Scale)	12 hours after surgery
Pain score	NRS (Numerical Rating Scale)	18 hours after surgery
Pain score	NRS (Numerical Rating Scale)	24 hours after surgery
Pain score	NRS (Numerical Rating Scale)	36 hours after surgery
Pain score	NRS (Numerical Rating Scale)	48 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	24 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Małgorzata Domagalska, Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Actual): January 16, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: 10/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No