Clinical trial NCT03148951: Effect of NLR and MPV on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations
Official title: Effect of Neutrophil /Lymphocyte Ratio (NLR) and Mean Platelet Volume (MPV) on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthropathy
Keywords: MPV
NLR
Postoperative pain
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 754
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing knee arthroplasty in 3 years period with general or spinal anesthesia.

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative VAS (visual analogue scale) score
timeFrame: VAS score at postoperative twenty-forth hours will be evaluated
Secondary outcomes:
measure: analgesic drugs
timeFrame: total dose of analgesic drugs required at twenty four hours will be evaluated
measure: postoperative major morbidities
timeFrame: at postoperative first, sixth, twelfth and twenty-forth hours
Other outcomes:
measure: postoperative side effects
timeFrame: at postoperative first, sixth, twelfth and twenty-forth hours
Locations:
city: Antalya
country: Turkey
facility: AkdenizU
Study officials:
affiliation: Akdeniz University Hospital
name: Ilker o Aycan, asso prof
role: PRINCIPAL_INVESTIGATOR
References: