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Completed

NCT Number: NCT03148951

Effect of NLR and MPV on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations

In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

AkdenizU

Antalya, 07058, Turkey (Türkiye)

About this study

  • In this study the investigators aim to determine the relation between the MPV and N/L ratio and the incidence of postoperative adverse events and complications in patients undergoing knee arthroplasty.
  • In this study only the laboratory tests that are routinely used for the operative patients are going to be used and no extra tests will be performed. The study will begin after the postoperative blood samples are collected for routine laboratory measurements. The patients will be allocated to 4 groups according to the type of anesthesia and VAS scores. Preoperative and postoperative peripheral blood total whole blood MPV and N/L ratio and 1st 6th 12th ve 24th hours VAS scores and complications, morbidities and mortality will be recorded. The patients will receive analgesics according to the routine practice in the ward and the doses of analgesics given will be recorded at 1st 6th 12th ve 24the hours wil be recorded.
  • Statistical analysis: the numerical variables will be analyzed tested with Kolmogorov-Smirnov test for normality. For the parametric variables that are normally distributed t-test will be used for the comparison between groups. For the parametric variables that are not normally distributed Mann Whitney-U test will be used. All the categorical variables will be evaluated with q- square tests. A p value < 0.05 will be determined as statistically significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • knee arthroplasty patients with general or spinal anesthesia.

Exclusion criteria

  • patients not giving consent
  • reoperations
  • patients having inflammatory disease
  • infection in the knee
  • sepsis
  • bleeding disorders
  • hematologic diseases,
  • using steroids.
  • trauma
  • fracture patients,
  • bilateral knee prothesis
  • combined surgery procedures
  • patients needing perioperative transfusions
  • uncooperative patients.

Treatment and study plan

Primary outcomes

  1. postoperative VAS (visual analogue scale) score

    Time frame: VAS score at postoperative twenty-forth hours will be evaluated

    postoperative visual analog scale score for pain evaluation 0,10,20,30,40,50,60,70,80,90,100)

Secondary outcomes

  1. analgesic drugs

    Time frame: total dose of analgesic drugs required at twenty four hours will be evaluated

    analgesic drugs given according to the routine practice in the ward

  2. postoperative major morbidities

    Time frame: at postoperative first, sixth, twelfth and twenty-forth hours

    postoperative Myocardial Infarction (MI), Acute Kidney Injury(AKI), and Cerebrovascular Events (CVO)s.

Other outcomes

  1. postoperative side effects

    Time frame: at postoperative first, sixth, twelfth and twenty-forth hours

    nausea, vomiting, abdominal pain, agitation, head ache, muscular weakness, dizziness,hiccups, bronchospasm, bradycardia, itching, urinary retention,

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Effect of Neutrophil /Lymphocyte Ratio (NLR) and Mean Platelet Volume (MPV) on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Jan 13, 2023

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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