- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07137702
- Original Trial
Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index
Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index in Breast-conserving Surgery: A Retrospective Cohort Study
The primary objective of the study is to determine whether there is a relationship between postoperative SII and erector spinae plane block application. If data emerges indicating a more suppressed inflammatory response in patients undergoing block, widespread use of this block in the specified patient group would reflect the clinical significance of the study.
The searches did not uncover any studies investigating the effects of trunk blocks, such as erector spinae plane block, on postoperative systemic inflammatory response, indicating that this study could make a significant contribution to the literature.
Study Overview
Status
Intervention / Treatment
Detailed Description
Because the study will be conducted retrospectively, it carries no potential risks.
If it can be demonstrated that blocking has a suppressive effect on the inflammatory response, the main expected benefit of the study is its widespread use to improve postoperative outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Basaksehir Cam ve Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: ASA score ≤ 3, breast-conversing surgery, age > 18 -
Exclusion Criteria: ASA score > 3, reoperation, surgical wound infection, chemotherapy in less than 2 weeks, bening lesions
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ESPB + group
the patients who received erector spinae plane block
|
A standardized perioperative care management protocol is applied for all breast-conserving surgery procedures in our department.
All patients are informed about ESPB and offered its application preoperatively.
Patients who accept the procedure receive ESPB (preoperatively, in the sitting position, at the level of ipsilateral T4 vertebra, USG guided, out-of-plane approach) while those who refuse are subjected to routine intravenous analgesia protocols.
All blocks were performed by an anesthesiologist experienced in the application of truncal blocks and 20 cc 0.5% bupivacaine (within the safe dose range for all patients to be used according to their weight) are injected and its spread is visualized under USG.
|
|
ESPB - group
the patients who didn't receive erector spinae plane block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
systemic immune-inflammation index
Time Frame: 7 days after surgery
|
Platelet count × Neutrophil count / Lymphocyte count
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7 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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