Postoperative PainNCT07056413
BRILMA Block in Breast-Conserving Surgery
A study testing BRILMA block and Standard intravenous analgesia. in people with Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Regional analgesia technique in addition to multimodal analgesia in breast-conserving surgery aims to reduce opioid consumption. This study evaluates the postoperative analgesic efficacy of ultrasound-guided BRILMA block in patients undergoing breast conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- BRILMA block and Standard intravenous analgesia.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast-conserving surgery
- ASA I-III
Who cannot join
- Patient refusal
- Presence of contraindications for regional anesthesia ( bleeding disorder, infection at the injection site, local anesthetic allergy)
- Chronic analgesic use
- Preoperative breast pain
- BMI >35
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul
About this study
Official title: BRILMA Block: A Regional Approach to Pain Management in Breast-Conserving Surgery
Regional analgesia technique in addition to multimodal analgesia in breast-conserving surgery aims to reduce opioid consumption. This study evaluates the postoperative analgesic efficacy of ultrasound-guided BRILMA block in patients undergoing breast conserving surgery.
Read the detailed description
Breast-conserving surgery has become a standard surgical approach in the management of early-stage breast malignancies. Despite being less invasive than other oncologic procedures, postoperative pain remains a significant concern. In postoperative pain management, the addition of regional analgesia techniques to multimodal approaches aims to reduce opioid consumption.
First described in 2013, the Serratus-Intercostal Interfascial Plane block targets the branches of the intercostal nerves at the level of the mid-axillary line, specifically around the fourth rib-an anatomical region referred to by the acronym BRILMA. This regional anesthesia technique has demonstrated efficacy in managing postoperative pain, particularly after breast surgery.
In the study, investigators planned to evaluate the postoperative analgesic efficacy of ultrasound-guided BRILMA block via 24-hour morphine consumption in patients undergoing breast conserving surgery.
- Conditions
- Postoperative Pain
- Being tested
- BRILMA block, Standard intravenous analgesia.
- Keywords
- BRILMA block, breast-conserving surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRILMA blockProcedure or surgery
20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.
Standard intravenous analgesia.Other
Standard intravenous analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group B: BRILMA block | Experimental | 20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level. Receives: Procedure: BRILMA block |
| Group C: Control | Other | Standard intravenous analgesia. Receives: Other: Standard intravenous analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Amount of morphine consumption
Measured: postoperative 24-hour
Secondary outcomes (8)
Static and dynamic pain scores assessed with numeric rating scale
pain scores recorded at 0., 1., 4., 8., 12., 24. hours postoperatively
Measured: postoperative 24 hours
number of blocked dermatome
pinprick test in mid-axillary and mid-claviculary line
Measured: 20. minute after block performance
Duration of block application
time from the insertion of probe to the removal of needle from skin
Measured: up to 15 minutes
Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]
Amount fentanyl use during surgery
Measured: during surgery
Rescue analgesia
number of patients needed rescue analgesia
Measured: postoperative 24 hours
Nausea and vomit
postoperative nausea and vomiting (0=no, 1= mild nausea, 2= severe nausea or vomiting)
Measured: postoperative 24 hours
Complications
Hematoma, vascular puncture, pneumothorax
Measured: Up to 24 hours
Patient's satisfaction
Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start22 Apr 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nukhet Sivrikoz, Istanbul University
- Investigators
- Nükhet Sivrikoz, Assoc. Prof. Dr., Principal investigator, Attending anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056413
- Sponsor's protocol ID
- 2023/676
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRILMA Block: A Regional Approach to Pain Management in Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07056413
- Acronym / sponsor ID
- 2023/676
- Conditions
- Postoperative Pain
- Keywords
- BRILMA block, breast-conserving surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 9 Jul 2025 (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.
Regional analgesia technique in addition to multimodal analgesia in breast-conserving surgery aims to reduce opioid consumption. This study evaluates the postoperative analgesic efficacy of ultrasound-guided BRILMA block in patients undergoing breast conserving surgery.
Detailed description
Breast-conserving surgery has become a standard surgical approach in the management of early-stage breast malignancies. Despite being less invasive than other oncologic procedures, postoperative pain remains a significant concern. In postoperative pain management, the addition of regional analgesia techniques to multimodal approaches aims to reduce opioid consumption.
First described in 2013, the Serratus-Intercostal Interfascial Plane block targets the branches of the intercostal nerves at the level of the mid-axillary line, specifically around the fourth rib-an anatomical region referred to by the acronym BRILMA. This regional anesthesia technique has demonstrated efficacy in managing postoperative pain, particularly after breast surgery.
In the study, investigators planned to evaluate the postoperative analgesic efficacy of ultrasound-guided BRILMA block via 24-hour morphine consumption in patients undergoing breast conserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: BRILMA block | Experimental | Procedure: BRILMA block20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level. |
| Group C: Control | Other | Other: Standard intravenous analgesia.Standard intravenous analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast-conserving surgery
- ASA I-III
Key exclusion criteria (5 listed)
- Patient refusal
- Presence of contraindications for regional anesthesia ( bleeding disorder, infection at the injection site, local anesthetic allergy)
- Chronic analgesic use
- Preoperative breast pain
- BMI >35
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 |
|---|---|---|
| BRILMA block20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level. | Procedure or surgery | Group B: BRILMA block |
| Standard intravenous analgesia.Standard intravenous analgesia. | Other | Group C: Control |
Primary outcome
Morphine consumption
Time frame: postoperative 24-hour
Amount of morphine consumption
8 secondary outcomes
Static and dynamic pain scores assessed with numeric rating scale
Time frame: postoperative 24 hours
number of blocked dermatome
Time frame: 20. minute after block performance
Duration of block application
Time frame: up to 15 minutes
Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]
Time frame: during surgery
Rescue analgesia
Time frame: postoperative 24 hours
Nausea and vomit
Time frame: postoperative 24 hours
Complications
Time frame: Up to 24 hours
Patient's satisfaction
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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. This study is not recruiting at the moment.
Nükhet Sivrikoz, Assoc. Prof. Dr. principal investigator
Attending anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRILMA block and Standard intravenous analgesia. in people with Postoperative Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: postoperative 24-hour). 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 9 Jul 2025.