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Clinical Trials/NCT06304298
NCT06304298CompletedPhase 4

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

Poznan University of Medical Sciences1 site in 1 country60 target enrollmentStarted: March 30, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Neutrophil-to-lymphocyte ratio

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
20 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Sham blocks

Active Comparator

iPACK block with 20ml of 0.9% sodium chloride

Intervention: 0.9% Sodium Chloride Injection (Drug)

iPACK block

Active Comparator

iPACK block with 20ml 0f 0.2% ropivacaine

Intervention: Ropivacaine 0.2% Injectable Solution (Drug)

Outcomes

Primary Outcomes

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

  • PLR(48 hours after surgery)
  • NLR(48 hours after surgery)
  • first need of opiate(48 hours after procedure)
  • Opioid Consumption(48 hours after surgery)
  • Pain score(48 hours after surgery)

Investigators

Sponsor
Poznan University of Medical Sciences
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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