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临床试验/NCT06533566
NCT06533566已完成不适用

Effect of Erector Spinae Plane Block Versus Local Wound Infiltration on Postoperative Pain After Modified Radical Mastectomy

Tanta University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
total morphine consumption

研究概览

简要总结

This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

详细描述

Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea & vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I & pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) physical status I-II
  • scheduled for unilateral Modified radical mastectomy

排除标准

  • Patient refusal.
  • Patient with neurological deficit.
  • Patient with bleeding disorders.
  • Uncooperative patient.
  • Infection at the block injection site.
  • Patients with history of allergy to local anesthetics.
  • Advanced hepatic, cardiac or renal failure.
  • Chronic opioid consumption.
  • Body mass index (BMI)≥ 30 kg m-2
  • Chronic use of gabapentin or pregabalin

结局指标

主要结局

total morphine consumption

时间窗: first postoperative day after modified radical mastectomy surgery

total morphine amount which will be consumed in the first postoperative day

次要结局

未报告次要终点

研究者

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

tarek abdel hay mostafa

principle investigator

Tanta University

研究点 (2)

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