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

NCT07648810 | Not Yet Recruiting

• 1 other identifier: uniri-iz-25-239
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer - Female

Outcome Measures

Primary Outcomes (1)

• Immune response in two different regional anesthesia techniques

  From enrollment to 30 days post surgery

Study Arms (3)

Draw of venous blood 1 hour prior surgery

EXPERIMENTAL

Draw of venous blood and application of paravertebral or erector spinae plane block

Procedure: Regional Anesthetic Injection

Draw of venous blood 24 hours after surgery

EXPERIMENTAL

Draw of venous blood

Procedure: Blood draw for the laboratory assessment

Draw of venous blood 48 hours after surgery

EXPERIMENTAL

Draw of venous blood

Procedure: Blood draw for the laboratory assessment

Interventions

Regional Anesthetic Injection PROCEDURE

Draw of venous blood and application of paravertebral and erector spinae plane block

Draw of venous blood 1 hour prior surgery

Blood draw for the laboratory assessment PROCEDURE

Draw of venous blood 24 hours after surgery

Draw of venous blood 24 hours after surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and ASA II status, normal BMI

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jan Maroević, medical doctor

CONTACT

+385981859039; jan.maroevic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06