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NCT Number: NCT07056413

BRILMA Block 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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast-conserving surgery
  • ASA I-III

Exclusion criteria

  • 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

Treatment and study plan

BRILMA block

Procedure

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.

Primary outcomes

  1. Morphine consumption

    Time frame: postoperative 24-hour

    Amount of morphine consumption

Secondary outcomes

  1. Static and dynamic pain scores assessed with numeric rating scale

    Time frame: postoperative 24 hours

    pain scores recorded at 0., 1., 4., 8., 12., 24. hours postoperatively

  2. number of blocked dermatome

    Time frame: 20. minute after block performance

    pinprick test in mid-axillary and mid-claviculary line

  3. Duration of block application

    Time frame: up to 15 minutes

    time from the insertion of probe to the removal of needle from skin

  4. Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]

    Time frame: during surgery

    Amount fentanyl use during surgery

  5. Rescue analgesia

    Time frame: postoperative 24 hours

    number of patients needed rescue analgesia

  6. Nausea and vomit

    Time frame: postoperative 24 hours

    postoperative nausea and vomiting (0=no, 1= mild nausea, 2= severe nausea or vomiting)

  7. Complications

    Time frame: Up to 24 hours

    Hematoma, vascular puncture, pneumothorax

  8. Patient's satisfaction

    Time frame: Up to 24 hours

    Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

BRILMA Block: A Regional Approach to Pain Management in Breast-Conserving Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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