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临床试验/NCT02930733
NCT02930733已完成4 期

The Effects of Bilateral Serratus Plane Block on Postoperative Opioid Consumption After Breast Reduction Surgery

Ataturk University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

Serratus plane block was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application and less adverse effects than neuroaxial blocks, has been defined after these blocks and has taken its place in the literature.In spite of the insufficient randomized clinical trials in the literature, SPB has been reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections, and the results are promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral serratus plane block in patients undergoing breast reduction surgery.

Main outcome measures: The primary endpoint is postoperative opioid consumption.

Secondary endpoints are visual analogue pain scores, opioid related side effects.

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 breast reduction surgery

排除标准

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

研究组 & 干预措施

ultrasound guided serratus plane block

Active Comparator

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

干预措施: Bupivacaine (Drug)

ultrasound guided sham block

Placebo Comparator

Bilateral ultrasound guided sham block with 2 ml saline subcutaneously

干预措施: Saline (Drug)

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

Ali Ahiskalioglu

MD

Ataturk University

研究点 (1)

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