BRILMA Block in Breast-Conserving Surgery

NCT ID: NCT07056413

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2025-05-05

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group B: BRILMA block

20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.

Group Type EXPERIMENTAL

BRILMA block

Intervention Type 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.

Group C: Control

Standard intravenous analgesia.

Group Type OTHER

Standard intravenous analgesia.

Intervention Type OTHER

Standard intravenous analgesia.

Interventions

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BRILMA block

20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.

Intervention Type PROCEDURE

Standard intravenous analgesia.

Standard intravenous analgesia.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nukhet Sivrikoz

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nükhet Sivrikoz, Assoc. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Attending anesthesiologist

Locations

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Istanbul University, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/676

Identifier Type: -

Identifier Source: org_study_id

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