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

E

Elazıg Fethi Sekin Sehir Hastanesi

Status

Completed

Conditions

Inflammatory Response in Total Knee Arthroplasty

Treatments

Other: Routine Clinical Anesthesia Practice

Study type

Observational

Funder types

Other

Identifiers

NCT07214558
EFSH-ANES-2025-09-DELTANEUTROP

Details and patient eligibility

About

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.

Full description

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.

Enrollment

84 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

Spinal Anesthesia Group
Description:
Patients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.
Treatment:
Other: Routine Clinical Anesthesia Practice
General Anesthesia Group
Description:
Patients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.
Treatment:
Other: Routine Clinical Anesthesia Practice

Trial contacts and locations

1

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Central trial contact

Sait F Öner; Sevim Şenol Karataş, MD

Data sourced from clinicaltrials.gov

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