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临床试验/NCT03341234
NCT03341234已完成不适用

Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study

Ataturk University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.

The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection 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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

排除标准

  • chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications

研究组 & 干预措施

Group Control

Active Comparator

Ultrasound guided sham block with 2 ml saline subcutaneously

干预措施: Saline (Drug)

Group SPB

Active Comparator

Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine

干预措施: Bupivacaine (Drug)

Group SPB

Active Comparator

Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine

干预措施: Ultrasound (Device)

Group Control

Active Comparator

Ultrasound guided sham block with 2 ml saline subcutaneously

干预措施: Ultrasound (Device)

结局指标

主要结局

Opioid Consumption

时间窗: First 24 hours total opioid consumption

First 24 hours total fentanyl consumption with patient controlled analgesia

次要结局

  • Visual analog pain score(postoperative 24th hour)

研究者

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

Ahmet Murat Yayik

Principal Investigator

Ataturk University

研究点 (1)

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