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Completed

NCT Number: NCT07214558

Spinal Versus General Anesthesia and Inflammatory Response Measured by Delta Neutrophil Index in Total Knee Arthroplasty: An Observational Study

This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. A total of at least 84 patients will be included, with anesthesia type determined according to routine clinical practice. Preoperative and postoperative blood tests will be analyzed, and no additional blood samples will be required.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences, Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

About this study

This prospective observational study will be conducted at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Patients undergoing total knee arthroplasty will be assigned to two groups based on the anesthesia method used in routine practice: spinal anesthesia or general anesthesia. The primary outcome measure is the Delta Neutrophil Index (DNI), an inflammation marker automatically calculated by hematology analyzers using complete blood count parameters. DNI values will be compared preoperatively and postoperatively between groups. Additional data including age, sex, ASA classification, duration of surgery, hemogram parameters, and perioperative complications will be collected. The sample size calculation indicated that a minimum of 42 patients per group (total 84) are required to detect significant differences in DNI levels with 80% power at a 5% significance level. Statistical analyses will include Kolmogorov-Smirnov test for normality, independent t test or Mann-Whitney U test for between-group comparisons, and paired t test or Wilcoxon test for within-group comparisons. A p-value <0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for total knee arthroplasty
  • Age ≥ 18 years
  • ASA physical status classification I-III

Exclusion criteria

  • Active infection
  • Hematologic disease (e.g., leukemia, aplastic anemia)
  • Autoimmune or chronic inflammatory disease
  • Use of corticosteroids or immunosuppressive drugs
  • Malignancy
  • Acute trauma or sepsis
  • Pregnancy

Treatment and study plan

Routine Clinical Anesthesia Practice

Other

Patients undergoing total knee arthroplasty will receive either spinal or general anesthesia as determined by routine clinical practice and the attending anesthesiologist's decision. Investigators will not influence the choice of anesthesia method.

Primary outcomes

  1. Change in Delta Neutrophil Index (DNI)

    Time frame: From baseline (preoperative) to 24 hours postoperative.

    Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.

Secondary outcomes

  1. Neutrophil Count

    Time frame: Preoperative to 24 hours postoperative.

    Absolute neutrophil count measured preoperatively and at 24 hours postoperatively.

  2. Perioperative Complications

    Time frame: Intraoperative and during hospital stay (up to 7 days).

    Incidence of complications such as infection, bleeding, or cardiovascular events.

  3. Operative Time

    Time frame: Intraoperative period.

    Duration of surgery recorded in minutes.

  4. Lymphocyte Count

    Time frame: Preoperative to 24 hours postoperative.

    Absolute lymphocyte count measured preoperatively and at 24 hours postoperatively.

  5. Neutrophil-to-Lymphocyte Ratio (NLR)

    Time frame: Preoperative to 24 hours postoperative.

    NLR calculated from complete blood count values preoperatively and at 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

he Effect of Spinal and General Anesthesia on Inflammatory Response Measured by Delta Neutrophil Index in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study

Acronym: DNA-TKA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2025
Registry last updated
Nov 26, 2025

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.