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Completed

NCT Number: NCT06304298

NLR and PLR Levels Following IPACK Block in Knee Arthroplasty

Effect of iPACK block on NLR and PLR following knee arthroplasty

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% sodium chloride injection

Drug

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

Other names: Placebo

Ropivacaine 0.2% Injectable Solution

Drug

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

Other names: iPACK block

Primary outcomes

  1. Neutrophil-to-lymphocyte ratio

    Time frame: 12 hours after surgery

    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.

Secondary outcomes

  1. PLR

    Time frame: 12 hours after surgery

    Platelet-to-lymphocyte ratio

  2. PLR

    Time frame: 24 hours after surgery

    Platelet-to-lymphocyte ratio

  3. PLR

    Time frame: 48 hours after surgery

    Platelet-to-lymphocyte ratio

  4. NLR

    Time frame: 24 hours after surgery

    Neutrophile-to-lymphocyte ratio

  5. NLR

    Time frame: 48 hours after surgery

    Neutrophile-to-lymphocyte ratio

  6. first need of opiate

    Time frame: 48 hours after procedure

    Time after surgery when the patient needs opiate for the first time

  7. Opioid Consumption

    Time frame: 48 hours after surgery

    Total opiate consumption after surgery

  8. Pain score

    Time frame: 4 hours after surgery

    NRS (Numerical Rating Scale)

  9. Pain score

    Time frame: 8 hours after surgery

    NRS (Numerical Rating Scale)

  10. Pain score

    Time frame: 12 hours after surgery

    NRS (Numerical Rating Scale)

  11. Pain score

    Time frame: 18 hours after surgery

    NRS (Numerical Rating Scale)

  12. Pain score

    Time frame: 24 hours after surgery

    NRS (Numerical Rating Scale)

  13. Pain score

    Time frame: 36 hours after surgery

    NRS (Numerical Rating Scale)

  14. Pain score

    Time frame: 48 hours after surgery

    NRS (Numerical Rating Scale)

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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