BRILMA Block in Breast-Conserving Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT07056413
• Lead Sponsor: Istanbul University

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.

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 Timeline

• Study Start: 2024-04-22
• Primary Completion: 2025-05-05
• Study Completion: 2025-05-05
• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine consumption	postoperative 24-hour	Amount of morphine consumption

Secondary Outcome Measures

Name	Time	Method
Static and dynamic pain scores assessed with numeric rating scale	postoperative 24 hours	pain scores recorded at 0., 1., 4., 8., 12., 24. hours postoperatively
number of blocked dermatome	20. minute after block performance	pinprick test in mid-axillary and mid-claviculary line
Duration of block application	up to 15 minutes	time from the insertion of probe to the removal of needle from skin
Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]	during surgery	Amount fentanyl use during surgery
Rescue analgesia	postoperative 24 hours	number of patients needed rescue analgesia
Nausea and vomit	postoperative 24 hours	postoperative nausea and vomiting (0=no, 1= mild nausea, 2= severe nausea or vomiting)
Complications	Up to 24 hours	Hematoma, vascular puncture, pneumothorax
Patient's satisfaction	Up to 24 hours	Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey