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Inflammatory Response: General vs Spinal Anesthesia

A Cellular-Level Assessment of the Inflammatory Response in Inguinal Hernia Repair Under General Versus Spinal Anesthesia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07567534
Enrollment
60
Registered
2026-05-05
Start date
2021-11-30
Completion date
2022-03-15
Last updated
2026-05-05

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

Conditions

Inguinal Hernia

Keywords

anesthesia,, cellular inflammation, inguinal hernia

Brief summary

Objective: This study aimed to compare the effects of general and spinal anesthesia on the inflammatory response by measuring intercellular adhesion molecule-1 (ICAM-1), P-selectin (SELP), and thrombomodulin (TM) levels in patients undergoing inguinal hernia repair. Materials and Methods: A total of 43 patients scheduled for IHR were divided into two groups: general anesthesia (Group G, n=21) and spinal anesthesia (Group S, n=22). Blood samples were collected at the following time points: for Group G-before induction (T0), after intubation (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3); for Group S-before spinal anesthesia (T0), after spinal anesthesia (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3). ICAM-1, SELP and TM levels were analyzed.

Detailed description

Approval for this study was obtained from the Clinical Research Ethics Committee of Istanbul Medipol University (approval number: E-10840098-772.02-5920, dated 18/11/21). The study was conducted at the University of Health Sciences, Istanbul Bagcılar Training and Research Hospital. Patients were included if they had provided informed consent for either regional or general anesthesia during preoperative evaluation; were aged between 18 and 65 years; had a body weight ≥45 kg and a body mass index (BMI) between 18-32 kg/m²; classified as American Society of Anesthesiologists (ASA) physical status I-II; and scheduled for elective IHR. Exclusion criteria were: history of hypertension, diabetes mellitus or malignancy; severe cardiovascular or cerebrovascular disease (e.g., decompensated heart failure, history of cerebrovascular accident); severe liver or renal dysfunction; hematologic disorders, thromboembolism or coagulopathies; chronic infections, immune or endocrine disorders; regular use of antiplatelet or anticoagulant medications; history of immune therapy or hormonal therapy; surgery or blood transfusion within the past month; pregnancy or lactation; preoperative abnormal white blood cell count or neutrophil percentage; hemoglobin \<8 g/dL; abnormal coagulation tests; or presence of intracranial space-occupying lesions or conditions associated with increased intracranial pressure. Exclusion during the study included: mechanical ventilation duration \>30 minutes, surgical changes or intraoperative complications. A power analysis performed prior to the study determined a minimum of 20 patients per group (total of 40) to achieve 80% power with α = 0.05 and β = 0.2. Considering potential exclusions, the sample size was increased by 50%, and 60 patients were evaluated for inclusion. Participants were randomly assigned using a computer-generated randomization program into two groups: general anesthesia (n=30) and spinal anesthesia (n=30). Following exclusions, the final analysis included 21 patients in the general anesthesia group (Group G) and 22 patients in the spinal anesthesia group (Group S).

Interventions

OTHERinflammatory response during inguinal hernia repair.

Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.

Sponsors

Sezen Kumaş Solak
Lead SponsorOTHER_GOV
Bagcilar Training and Research Hospital
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

A total of 60 patients scheduled for IHR were divided into two groups: general anesthesia (Group G, n=30) and spinal anesthesia (Group S, n=30). Blood samples were collected at the following time points: for Group G-before induction (T0), after intubation (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3); for Group S-before spinal anesthesia (T0), after spinal anesthesia (T1), 15 minutes after surgical incision (T2) and 15 minutes after final skin suturing (T3). ICAM-1, SELP and TM levels were analyzed.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

nclusion Criteria: Age between 18 and 65 years Patients scheduled for elective inguinal hernia repair American Society of Anesthesiologists (ASA) physical status I-II Body mass index (BMI) between 18 and 32 kg/m² Body weight ≥45 kg Patients who provided informed consent for general or spinal anesthesia

Exclusion criteria

History of hypertension, diabetes mellitus, or malignancy Severe cardiovascular or cerebrovascular disease Severe hepatic or renal dysfunction Hematologic disorders, coagulopathy, or thromboembolic disease Chronic infection, immune, or endocrine disorders Use of antiplatelet or anticoagulant medications History of immunotherapy or hormonal therapy Surgery or blood transfusion within the past 1 month Pregnancy or breastfeeding Abnormal preoperative white blood cell count or neutrophil percentage Hemoglobin \<8 g/dL Abnormal coagulation test results Intracranial space-occupying lesion or increased intracranial pressure

Design outcomes

Primary

MeasureTime frameDescription
Perioperative change in serum inflammatory markersPerioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) levelBaseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure

Secondary

MeasureTime frameDescription
Perioperative MAP values, preoperative inflammatory blood markersBaseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closureSecondary outcomes included perioperative MAP values measured ,inflammatory markers (leukocyte count, neutrophil percentage, and neutrophil-to-lymphocyte ratio)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026