Inguinal HerniaNCT07567534
Inflammatory Response: General vs Spinal Anesthesia
A study testing inflammatory response during inguinal hernia repair. in people with Inguinal Hernia, run by Sezen Kumaş Solak at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- inflammatory response during inguinal hernia repair.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcılar Training Research Hospital
Istanbul, 34200
About this study
Official title: A Cellular-Level Assessment of the Inflammatory Response in Inguinal Hernia Repair Under General Versus Spinal Anesthesia
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.
Read more
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.
Read the 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).
- Conditions
- Inguinal Hernia
- Being tested
- inflammatory response during inguinal hernia repair.
- Keywords
- anesthesia,, cellular inflammation, inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory response during inguinal hernia repair.Other
Also called spinal anesthesia, general anesthesia
Compared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia (n=30) | Other | Following 3 minutes of preoxygenation with 100% oxygen via face mask, anesthesia was induced with IV propofol (2.5 mg/kg) and fentanyl (1 µg/kg). Once loss of consciousness was confirmed, IV rocuronium (0.2 mg/kg) was administered to facilitate insertion of a laryngeal mask airway (LMA). LMA sizes 3 or 4 were used for female patients and sizes 4 or 5 for male patients based on weight. Correct LMA placement was confirmed by auscultation Receives: Other: inflammatory response during inguinal hernia repair. |
| spinal anesthesia (n=30). | Other | With the patient in a seated position (knees slightly flexed, head bent forward, arms crossed at chest level), a 25G Quincke needle was inserted via the midline approach at the L4-L5 interspace. After confirming free flow of clear cerebrospinal fluid, 2.5-3 mL (12.5-15 mg) of hyperbaric bupivacaine was injected into the subarachnoid space based on patient height. Sensory and motor block levels were assessed. Receives: Other: inflammatory response during inguinal hernia repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change in serum inflammatory markers
Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
Measured: Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level
Secondary outcomes (1)
Perioperative MAP values, preoperative inflammatory blood markers
Secondary outcomes included perioperative MAP values measured ,inflammatory markers (leukocyte count, neutrophil percentage, and neutrophil-to-lymphocyte ratio)
Measured: Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start30 Nov 2021
- Primary completion1 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sezen Kumaş Solak
- Sponsor type
- Other government
- Collaborators
- Bagcilar Training and Research Hospital
- Responsible party
- Sponsor-investigator, Sezen Kumaş Solak, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567534
- Sponsor's protocol ID
- SBU BAGCILAR
- Other IDs
- Sezen Kumaş SOLAK
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finsterwald M, Muster M, Farshad M, Saporito A, Brada M, Aguirre JA. Spinal versus general anesthesia for lumbar spine surgery in high risk patients: Perioperative hemodynamic stability, complications and costs. J Clin Anesth. 2018 May;46:3-7. doi: 10.1016/j.jclinane.2018.01.004. Epub 2018 Jan 6.
PubMed 29316474Singh V, Kaur R, Kumari P, Pasricha C, Singh R. ICAM-1 and VCAM-1: Gatekeepers in various inflammatory and cardiovascular disorders. Clin Chim Acta. 2023 Aug 1;548:117487. doi: 10.1016/j.cca.2023.117487. Epub 2023 Jul 11.
PubMed 37442359Di Vita G, D'Agostino P, Patti R, Arcara M, Caruso G, Davi V, Cillari E. Acute inflammatory response after inguinal and incisional hernia repair with implantation of polypropylene mesh of different size. Langenbecks Arch Surg. 2005 Aug;390(4):306-11. doi: 10.1007/s00423-004-0534-3. Epub 2005 Feb 3.
PubMed 15690201
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cellular-Level Assessment of the Inflammatory Response in Inguinal Hernia Repair Under General Versus Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07567534
- Acronym / sponsor ID
- SBU BAGCILAR
- Conditions
- Inguinal Hernia
- Keywords
- anesthesia,, cellular inflammation, inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sezen Kumaş SolakOther government
- Collaborators
- Bagcilar Training and Research Hospital
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| general anesthesia (n=30) | Other | Other: inflammatory response during inguinal hernia repair.Following 3 minutes of preoxygenation with 100% oxygen via face mask, anesthesia was induced with IV propofol (2.5 mg/kg) and fentanyl (1 µg/kg). Once loss of consciousness was confirmed, IV rocuronium (0.2 mg/kg) was administered to facilitate insertion of a laryngeal mask airway (LMA). LMA sizes 3 or 4 were used for female patients and sizes 4 or 5 for male patients based on weight. Correct LMA placement was confirmed by auscultation |
| spinal anesthesia (n=30). | Other | Other: inflammatory response during inguinal hernia repair.With the patient in a seated position (knees slightly flexed, head bent forward, arms crossed at chest level), a 25G Quincke needle was inserted via the midline approach at the L4-L5 interspace. After confirming free flow of clear cerebrospinal fluid, 2.5-3 mL (12.5-15 mg) of hyperbaric bupivacaine was injected into the subarachnoid space based on patient height. Sensory and motor block levels were assessed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inflammatory response during inguinal hernia repair.Also: spinal anesthesia, general anesthesiaCompared to general anesthesia, spinal anesthesia may result in a reduced inflammatory response during inguinal hernia repair. | Other | general anesthesia (n=30), spinal anesthesia (n=30). |
Primary outcome
Perioperative change in serum inflammatory markers
Time frame: Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level
Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
1 secondary outcome
Perioperative MAP values, preoperative inflammatory blood markers
Time frame: Baseline (preoperative), immediately after anesthesia induction (before incision), 15 minutes after surgical incision, and 15 minutes after skin closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 29316474Finsterwald M, Muster M, Farshad M, Saporito A, Brada M, Aguirre JA. Spinal versus general anesthesia for lumbar spine surgery in high risk patients: Perioperative hemodynamic stability, complications and costs. J Clin Anesth. 2018 May;46:3-7. doi: 10.1016/j.jclinane.2018.01.004. Epub 2018 Jan 6.
- Background: PubMed 37442359Singh V, Kaur R, Kumari P, Pasricha C, Singh R. ICAM-1 and VCAM-1: Gatekeepers in various inflammatory and cardiovascular disorders. Clin Chim Acta. 2023 Aug 1;548:117487. doi: 10.1016/j.cca.2023.117487. Epub 2023 Jul 11.
- Results publication: PubMed 15690201Di Vita G, D'Agostino P, Patti R, Arcara M, Caruso G, Davi V, Cillari E. Acute inflammatory response after inguinal and incisional hernia repair with implantation of polypropylene mesh of different size. Langenbecks Arch Surg. 2005 Aug;390(4):306-11. doi: 10.1007/s00423-004-0534-3. Epub 2005 Feb 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflammatory response during inguinal hernia repair. in people with Inguinal Hernia, run by Sezen Kumaş Solak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative change in serum inflammatory markers (time frame: Perioperative change in serum ICAM-1 level,P-selectin (SELP) level,thrombomodulin (TM) level). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567534, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.