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临床试验/NCT06737458
NCT06737458已完成不适用

Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7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
40
试验地点
1
主要终点
Total dose of pethidine consumption

研究概览

简要总结

This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

详细描述

Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).

Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.

Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.

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
None

入排标准

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

入选标准

  • Women aged >20 years.
  • Patient's approval.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Patients underwent breast surgeries.

排除标准

  • Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
  • Advanced heart block, ventricular dysfunction.
  • Skin infection at the site of injection.
  • Pre-existing chronic pain.
  • Coagulopathies, significant liver or renal insufficiency.

研究组 & 干预措施

Serratus anterior plane block group

Active Comparator

Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

干预措施: Bupivacaine + Dexmedetomidine (Drug)

Erector spinae plane block group

Experimental

Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.

干预措施: Bupivacaine + Dexmedetomidine (Drug)

结局指标

主要结局

Total dose of pethidine consumption

时间窗: 24 hours postoperatively

Patients get 1 g paracetamol IV like clockwork. Salvage absence of pain as bolus IV pethidine at 0.5 mg/kg was managed if NRS \> 3

次要结局

  • Intraoperative fentanyl consumption(Intraoperatively)
  • Heart rate(Every 15 minutes until the end of the surgery (Up to 2 hours))
  • Mean arterial pressure(Every 15 minutes until the end of the surgery (Up to 2 hours))
  • Degree of pain(24 hours postoperatively)
  • Incidence of complications(24 hours postoperatively)

研究者

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

Hend Saad Rizk Farhat

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt

Kafrelsheikh University

研究点 (1)

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