NLR and PLR Levels Following IPACK Block in Knee Arthroplasty

NCT ID: NCT06304298

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2025-02-10

Brief Summary

Effect of iPACK block on NLR and PLR following knee arthroplasty

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.

Conditions

Knee Arthropathy; Knee Osteoarthritis; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham blocks

iPACK block with 20ml of 0.9% sodium chloride

Group Type: ACTIVE_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type: DRUG

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride

iPACK block

iPACK block with 20ml 0f 0.2% ropivacaine

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine

Interventions

0.9% Sodium Chloride Injection

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride

Intervention Type: DRUG

Ropivacaine 0.2% Injectable Solution

After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine

Intervention Type: DRUG

Other Intervention Names

Placebo; iPACK block

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Małgorzata Domagalska, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Poznań University of Medical Sciences

Locations

Poznan University of Medical Sciences

Poznan, Poznań, Poland

Countries

Poland

Other Identifiers

10/2023

Identifier Type: -

Identifier Source: org_study_id