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

Recruiting

• Conditions: Inflammatory Response in Total Knee Arthroplasty

• Registration Number: NCT07214558
• Lead Sponsor: Elazıg Fethi Sekin Sehir Hastanesi

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.

Study Timeline

• Study Start: 2025-09-22
• Study First Submitted: 2025-09-22
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2025-10-22
• Study Completion: 2025-10-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Neutrophil Count	Preoperative to 24 hours postoperative.	Absolute neutrophil count measured preoperatively and at 24 hours postoperatively.
Perioperative Complications	Intraoperative and during hospital stay (up to 7 days).	Incidence of complications such as infection, bleeding, or cardiovascular events.
Operative Time	Intraoperative period.	Duration of surgery recorded in minutes.
Lymphocyte Count	Preoperative 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.

Trial Locations

Locations (1)

University of Health Sciences, Elazığ Fethi Sekin City Hospital; Elâzığ, Merkez, Turkey (Türkiye)