NCT07137702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 16, 2025

Last Update Submit

August 16, 2025

Conditions

Keywords

systemic immune-inflammatory indexerector spinae plane blockbreast conserving surgery

Outcome Measures

Primary Outcomes (1)

  • systemic immune-inflammation index

    Platelet count × Neutrophil count / Lymphocyte count

    7 days after surgery

Study Arms (2)

ESPB + group

the patients who received erector spinae plane block

Procedure: Erector Spinae Plane Block

ESPB - group

the patients who didn't receive erector spinae plane block

Interventions

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women who have undergone breast-conserving surgery for malignant causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 22, 2025

Study Start

July 15, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations