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临床试验/NCT02839083
NCT02839083Unknown不适用

Thoracic Paravertebral Block Versus Pecs II Block for Perioperative Analgesia in Modified Radical Mastectomy

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Pain scores

研究概览

简要总结

Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.

详细描述

Various modalities have been used for perioperative pain management in relevance to breast surgery. Thoracic epidural and paravertebral blocks (PVB) became the gold standard techniques to achieve this goal. However, both techniques may be associated with devastating complications such as spinal cord injury, total spinal anesthesia, inadvertent intravascular injection and pneumothorax.

On the other hand, the advancement of ultrasound (US) technology and our ability to visualize the pleura and other structures in and around the paravertebral space has increased interest in performing thoracic paravertebral blocks guided by US.

"Pecs" block is a less invasive procedure involving US guided interfascial injections has been suggested as potential alternative analgesic technique. The Pecs I block was initially described by Blanco for minor breast surgery. A year later, on 2012, he described a Pecs II block or "modified Pecs block" for breast surgery involving the axilla.

The Pecs I block targets the medial pectoral nerve (MPN) from C8 and T1 and the lateral pectoral nerve (LPN) from C5, C6, and C7. These nerves arise from the medial and lateral cords of the brachial plexus, respectively, and innervate the pectoralis muscles.

The Pecs II block targets the T2-6 intercostal nerves, the long thoracic nerve which supplies the serratus anterior, and the thoracodorsal nerve which supplies the latissimus dorsi. Potential complications include accidental intravascular injection and pneumothorax.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • American Association for Anesthesiologists physical status I or II
  • Body mass index > 40 kg/m2

排除标准

  • Patient refusal
  • Severe or uncompensated cardiovascular disease.
  • Significant renal disease.
  • Significant hepatic disease.
  • Significant endocrinal disease.
  • Pregnancy.
  • Postpartum period.
  • Lactating females.
  • Allergy to any of the study medication.
  • Coagulation disorders.
  • Infection at the site of needle insertion.

结局指标

主要结局

Pain scores

时间窗: For 24 hours after surgery

Pain visual analog scale is used to assess the severity of postoperative pain

次要结局

  • Duration of postoperative analgesia(for 12 hours after surgery)
  • Cumulative postoperative meperidine consumption(for 48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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