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临床试验/NCT07056413
NCT07056413已完成不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast-conserving surgery
  • ASA I-III

排除标准

  • Patient refusal
  • Presence of contraindications for regional anesthesia ( bleeding disorder, infection at the injection site, local anesthetic allergy)
  • Chronic analgesic use
  • Preoperative breast pain

结局指标

主要结局

Morphine consumption

时间窗: postoperative 24-hour

Amount of morphine consumption

次要结局

  • 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)
  • Nausea and vomit(postoperative 24 hours)
  • Complications(Up to 24 hours)
  • Patient's satisfaction(Up to 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nukhet Sivrikoz

Attending Anesthesiologist

Istanbul University

研究点 (1)

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