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临床试验/NCT03148951
NCT03148951已完成不适用

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

Akdeniz University1 个研究点 分布在 1 个国家目标入组 754 人开始时间: 2017年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
754
试验地点
1
主要终点
postoperative VAS (visual analogue scale) score

研究概览

简要总结

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.

详细描述

  • 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • knee arthroplasty patients with general or spinal anesthesia.

排除标准

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

结局指标

主要结局

postoperative VAS (visual analogue scale) score

时间窗: 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)

次要结局

  • analgesic drugs(total dose of analgesic drugs required at twenty four hours will be evaluated)
  • postoperative major morbidities(at postoperative first, sixth, twelfth and twenty-forth hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlker Onguc Aycan

Associated Professor

Akdeniz University

研究点 (1)

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