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临床试验/NCT05352282
NCT05352282已完成不适用

Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月1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
50
试验地点
1
主要终点
analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy

研究概览

简要总结

Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .

Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.

Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.

We assumed that SAPB could safely provide a better analgesic profile with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.

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
None

入排标准

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

入选标准

  • 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery

排除标准

  • Patient refusal.
  • Patient with significant neurological , psychiatric or neuromuscular disease
  • Alcoholism .
  • Drug abuse .
  • Pregnancy or lactating women .
  • Suspected Coagulopathy .
  • Morbid obesity .
  • Known allergy to study medications .
  • Septicaemia and local infection at the block site.

结局指标

主要结局

analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy

时间窗: 1 year

compare the analgesic effect between serratus anterior plane block and lumbar intrathecal fentanyl injection by using visual analogue score (vas). -Postoperative pain will be assessed using visual analog score (VAS) \[0-10\]. 0 - 3 mild pain 4 - 6 moderate pain 7 - 10 severe pain 10 \<unbearable pain)

次要结局

  • Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy(1 year)
  • Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy(one year)

研究者

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

Ahmed Mohamed Nozahy

resident doctor at anesthesia and ICU department

Sohag University

研究点 (1)

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