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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07214558
Acronym
DNA-TKA
Enrollment
84
Registered
2025-10-09
Start date
2025-09-22
Completion date
2025-10-22
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response in Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty, Spinal Anesthesia, General Anesthesia, Delta Neutrophil Index, Inflammatory Response

Brief summary

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.

Detailed 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.

Interventions

OTHERRoutine Clinical Anesthesia Practice

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.

Sponsors

Elazıg Fethi Sekin Sehir Hastanesi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Delta Neutrophil Index (DNI)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

MeasureTime frameDescription
Neutrophil CountPreoperative to 24 hours postoperative.Absolute neutrophil count measured preoperatively and at 24 hours postoperatively.
Perioperative ComplicationsIntraoperative and during hospital stay (up to 7 days).Incidence of complications such as infection, bleeding, or cardiovascular events.
Operative TimeIntraoperative period.Duration of surgery recorded in minutes.
Lymphocyte CountPreoperative to 24 hours postoperative.Absolute lymphocyte count measured preoperatively and at 24 hours postoperatively.
Neutrophil-to-Lymphocyte Ratio (NLR)Preoperative to 24 hours postoperative.NLR calculated from complete blood count values preoperatively and at 24 hours postoperatively.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026