Breast Cancer - FemaleIRPVBESPNCT07648810
Comparison Immune Response in Paravertebral and Erector Spinal Plane Block in Breast Cancer Patients
A study testing Regional Anesthetic Injection and Blood draw for the laboratory assessment in people with Breast Cancer - Female, run by Clinical Hospital Center Rijeka.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer - Female
- What is being tested?
- Regional Anesthetic Injection and Blood draw for the laboratory assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and ASA II status, normal BMI
Who cannot join
- ASA III and ASA IV status, coagulopathy, chronic opioid use, diabetes, local infection of the skin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Regional Anesthetic Injection, Blood draw for the laboratory assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Anesthetic InjectionProcedure or surgery
Draw of venous blood and application of paravertebral and erector spinae plane block
Blood draw for the laboratory assessmentProcedure or surgery
Draw of venous blood 24 hours after surgery
Blood draw for the laboratory assessmentProcedure or surgery
Blood draw 48 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Draw of venous blood 1 hour prior surgery | Experimental | Draw of venous blood and application of paravertebral or erector spinae plane block Receives: Procedure: Regional Anesthetic Injection |
| Draw of venous blood 24 hours after surgery | Experimental | Draw of venous blood Receives: Procedure: Blood draw for the laboratory assessment |
| Draw of venous blood 48 hours after surgery | Experimental | Draw of venous blood Receives: Procedure: Blood draw for the laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response in two different regional anesthesia techniques
Measured: From enrollment to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - FemaleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648810
- Sponsor's protocol ID
- uniri-iz-25-239
- Acronym
- IRPVBESP
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Response in Breast Cancer Before and After Application of Paravertebral and Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT07648810
- Acronym / sponsor ID
- IRPVBESP / uniri-iz-25-239
- Conditions
- Breast Cancer - Female
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 15 Jun 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Draw of venous blood 1 hour prior surgery | Experimental | Procedure: Regional Anesthetic InjectionDraw of venous blood and application of paravertebral or erector spinae plane block |
| Draw of venous blood 24 hours after surgery | Experimental | Procedure: Blood draw for the laboratory assessmentDraw of venous blood |
| Draw of venous blood 48 hours after surgery | Experimental | Procedure: Blood draw for the laboratory assessmentDraw of venous blood |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and ASA II status, normal BMI
Key exclusion criteria (1 listed)
- ASA III and ASA IV status, coagulopathy, chronic opioid use, diabetes, local infection of the skin
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 |
|---|---|---|
| Regional Anesthetic InjectionDraw of venous blood and application of paravertebral and erector spinae plane block | Procedure or surgery | Draw of venous blood 1 hour prior surgery |
| Blood draw for the laboratory assessmentDraw of venous blood 24 hours after surgery | Procedure or surgery | Draw of venous blood 24 hours after surgery |
| Blood draw for the laboratory assessmentBlood draw 48 hours after surgery | Procedure or surgery | Draw of venous blood 48 hours after surgery |
Primary outcome
Immune response in two different regional anesthesia techniques
Time frame: From enrollment to 30 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Anesthetic Injection and Blood draw for the laboratory assessment in people with Breast Cancer - Female, run by Clinical Hospital Center Rijeka.
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 1 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: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Maroević, medical doctor (+385981859039, jan.maroevic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response in two different regional anesthesia techniques (time frame: From enrollment to 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.