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CompletedNCT03148951Updated Jan 13, 2023

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

An observational study in Knee Arthropathy, sponsored by Akdeniz University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by Akdeniz University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
754
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Knee Arthropathy

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Keywords

  • MPV
  • NLR
  • Postoperative pain
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 754 is above the median of 100 across 216 observational studies indexed under Joint Diseases.

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Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All consecutive patients undergoing knee arthroplasty in 3 years period with general or spinal anesthesia.

Inclusion criteria

  • knee arthroplasty patients with general or spinal anesthesia.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
754 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1

    Group 1: patients receiving general anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

  • Group 2

    Group 2: patients receiving general anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

  • Group 3

    Group 3: patients receiving regional (spinal) anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

  • Group 4

    Group 4: patients receiving spinal anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval.

06

What researchers measure

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. analgesic drugs

    analgesic drugs given according to the routine practice in the ward

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

  2. postoperative major morbidities

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

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

Other outcomes

  1. postoperative side effects

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

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

07

Study locations

1 site
  • AkdenizU
    Antalya, 07058, Turkey
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03148951
Lead sponsor
Akdeniz University
Responsible party
İlker Onguc Aycan (Associated Professor, Akdeniz University) — Principal investigator
First posted
May 11, 2017
Start date
Jun 28, 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Last update
Jan 13, 2023

Study contacts

Ilker o Aycan, asso prof
principal investigator · Akdeniz University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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