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

NCT ID: NCT07214558

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2025-10-22

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.

Conditions

Inflammatory Response in Total Knee Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinal Anesthesia Group

Patients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.

Routine Clinical Anesthesia Practice

Intervention Type: 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.

General Anesthesia Group

Patients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.

Routine Clinical Anesthesia Practice

Intervention Type: 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.

Interventions

Routine 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elazıg Fethi Sekin Sehir Hastanesi

OTHER

Sponsor Role: lead

Responsible Party

Sevim Şenol Karataş

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevim Şenol Karataş

Role: PRINCIPAL_INVESTIGATOR

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Locations

University of Health Sciences, Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.

Reference Type: BACKGROUND

PMID: 33067685 (View on PubMed)

Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.

Reference Type: BACKGROUND

PMID: 18715852 (View on PubMed)

Related Links

https://elazigsehir.saglik.gov.tr/

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Other Identifiers

EFSH-ANES-2025-09-DELTANEUTROP

Identifier Type: -

Identifier Source: org_study_id