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临床试验/NCT05624151
NCT05624151已完成3 期

Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery: A Prospective, Randomized Double Blinded Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年11月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
75
试验地点
1
主要终点
first time to analgesic requirment

研究概览

简要总结

Regional analgesia is considered the cornerstone for postoperative analgesia in paediatric patients. One of the most common birth defects which require surgical intervention early in life is the cleft lip. Infraorbital nerve block (IONB) has been used for postoperative analgesia in this delicate and sensitive area.

As the assessment of pain may be very challenging especially in young children, the local anaesthetics administration can be a safe alternative to opioids.[2] However, the regional block after a single dose of local anaesthetic is of limited duration and efficacy. Hence, the coadministration of adjuvants with local anaesthetics may be helpful for potentiation of analgesic effect.

Infraorbital nerve block is a well-recognized regional anaesthetic technique which can provide intraoperative and postoperative pain relief in nasal endoscopic surgery and in some types of oral and dental surgery including cleft lip repair . The block may also be used to help diagnose neuralgia arising from the second division of the trigeminal nerve. The technique for infraorbital nerve blockade is most performed as it exits the infraorbital foramen just below the inferior orbital rim.Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. [9, 10] perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption. The exact mechanism of peripheral nerve block produced by α2 adrenoreceptor agonists includes central analgesia, anti-inflammatory effect.Another suggested mechanism is that DE may exert its action through blocking the hyperpolarization-activated cation current after the transient sodium influx. The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research have also reported that the intraoperative use of magnesium is characterized by a reduced use of anaesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate. In a study performed by (El-Emam and El motlb) in 2019 they compared the efficacy of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided infraorbital nerve block in paediatric patients scheduled for cleft lip repair. they noticed that dexmedetomidine produced a more prolonged duration of analgesia and a lower pain score and increased sedation than produced by dexamethasone. Also, they found that Both dexamethasone and dexmedetomidine were tolerable with no significant difference regarding the incidence of postoperative nausea and vomiting or intraoperative hemodynamic changes.Aim of the work:

The purpose of this randomized controlled double-blind study is to compare the efficacy of Dexmedetomidine or Magnesium sulphate as adjuvants for bupivacaine in infraorbital nerve block in paediatric patients scheduled for cleft lip repair.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients who will be scheduled for indicated cleft lip surgery. • physical status American Society of Anesthesiologists (ASA) I or II.

排除标准

  • failure to gain the consent from parents
  • allergy to any of drugs used
  • coagulopathy
  • thrombocytopenia
  • history of any lower or upper airway disorders
  • history of sleep apnea syndrome with a suspected need for postoperative ventilation
  • any wound or infection related to puncture site
  • major illness failure to gain the consent of parents.

研究组 & 干预措施

general anesthesia+ infraorbital nerve block by dexmedetomidine plus bupivacaine

Active Comparator

干预措施: Dexmedetomidine +Bupivacaine (Drug)

general anesthesia+ infraorbital nerve block by magnesium sulphate plus bupivacaine

Active Comparator

干预措施: Magnesium Sulfate + Bupivacaine (Drug)

general anesthesia+infraorbital nerve block by bupivacaine only

Active Comparator

干预措施: Bupivacaine (Drug)

结局指标

主要结局

first time to analgesic requirment

时间窗: 1st 24 hour

paracetamol will be given as the first rescue analgesia

次要结局

  • postoperative side effects(1st 24 hour postoperatively)
  • Total amount of analgesics(1st 24 hours postoperatively)
  • pain score (FLACC Score) face, leg , cry, activity ,conslolability(1st 24 postoperatively)

研究者

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

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Ain Shams University

研究点 (1)

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