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

Knee Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148951
• Other study ID #: MANLOP
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: January 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 754
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Locations

Country	Name	City	State
Turkey	AkdenizU	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative side effects	nausea, vomiting, abdominal pain, agitation, head ache, muscular weakness, dizziness,hiccups, bronchospasm, bradycardia, itching, urinary retention,	at postoperative first, sixth, twelfth and twenty-forth hours
Primary	postoperative VAS (visual analogue scale) score	postoperative visual analog scale score for pain evaluation 0,10,20,30,40,50,60,70,80,90,100)	VAS score at postoperative twenty-forth hours will be evaluated
Secondary	analgesic drugs	analgesic drugs given according to the routine practice in the ward	total dose of analgesic drugs required at twenty four hours will be evaluated
Secondary	postoperative major morbidities	postoperative Myocardial Infarction (MI), Acute Kidney Injury(AKI), and Cerebrovascular Events (CVO)s.	at postoperative first, sixth, twelfth and twenty-forth hours

External Links

•   Neutrophil/Lymphocyte Ratio as a Predictor of In-Hospital Major Adverse Cardiac Events, New-Onset Atrial Fibrillation, and No-Reflow Phenomenon in Patients with ST Elevation Myocardial Infarction
•   The role of mean platelet volume in patients with non-specific abdominal pain in an emergency department