BRILMA Block in Breast-Conserving Surgery
BRILMA Block: A Regional Approach to Pain Management in Breast-Conserving Surgery
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Apr 2024
Typical duration for not_applicable postoperative-pain
1 active site
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
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2025
CompletedFirst Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 9, 2025
CompletedJuly 9, 2025
June 1, 2025
1 year
June 30, 2025
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption
Amount of morphine consumption
postoperative 24-hour
Secondary Outcomes (8)
Static and dynamic pain scores assessed with numeric rating scale
postoperative 24 hours
number of blocked dermatome
20. minute after block performance
Duration of block application
up to 15 minutes
Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]
during surgery
Rescue analgesia
postoperative 24 hours
- +3 more secondary outcomes
Study Arms (2)
Group B: BRILMA block
EXPERIMENTAL20 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
OTHERStandard intravenous analgesia.
Interventions
20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.
Eligibility Criteria
You may qualify if:
- Breast-conserving surgery
- ASA I-III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nükhet Sivrikoz, Assoc. Prof. Dr.
Attending anesthesiologist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Anesthesiologist
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 9, 2025
Study Start
April 22, 2024
Primary Completion
May 5, 2025
Study Completion
May 5, 2025
Last Updated
July 9, 2025
Record last verified: 2025-06