Comparison Immune Response in Paravertebral and Erector Spinal Plane Block in Breast Cancer Patients (IRPVBESP)

June 10, 2026 updated by: Clinical Hospital Center Rijeka

Immunologic Response in Breast Cancer Before and After Application of Paravertebral and Erector Spinae Plane Block

The goal of this clinical trial is to find the difference in immune response between two types of regional anesthesia in female patients suffering from breast cancer.

The main question it aims to answer is there a difference in the immune response between paravertebral block and erector spinal plane block.

Hypothresis of the study is that paravertebral block with propofol induces less immune response in surgical treatment of breast cancer patients than erector spinal plane block.

Participants will be asked to sign the informant consent. They will be given either paravertebral block or erector spinae plane block with general anesthesia using propofol. Their venous blood will be taken 1 hour prior surgery and 24 and 48 hours after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I and ASA II status, normal BMI

Exclusion Criteria:

  • ASA III and ASA IV status, coagulopathy, chronic opioid use, diabetes, local infection of the skin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Draw of venous blood 1 hour prior surgery
Draw of venous blood and application of paravertebral or erector spinae plane block
Procedure: Regional Anesthetic Injection
Draw of venous blood and application of paravertebral and erector spinae plane block
Experimental: Draw of venous blood 24 hours after surgery
Draw of venous blood
Procedure: Blood draw for the laboratory assessment
Draw of venous blood 24 hours after surgery
Procedure: Blood draw for the laboratory assessment
Blood draw 48 hours after surgery
Experimental: Draw of venous blood 48 hours after surgery
Draw of venous blood
Procedure: Blood draw for the laboratory assessment
Draw of venous blood 24 hours after surgery
Procedure: Blood draw for the laboratory assessment
Blood draw 48 hours after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune response in two different regional anesthesia techniques
Time Frame: From enrollment to 30 days post surgery
From enrollment to 30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Center Rijeka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uniri-iz-25-239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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