Dexmedetomidine Versus Magnesium Sulphate Added to Bupivacaine in Infraorbital Nerve Block for Perioperative Analgesia in Paediatric Patients for Cleft Lip Surgery
Condition: Analgesia
MeSH terms: Cleft Lip
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): Dexmedetomidine +Bupivacaine; Magnesium Sulfate + Bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): infraorbital nerve block by dexmedetomidine plus bupivacaine; infraorbital nerve block by magnesium sulphate plus bupivacaine; infraorbital nerve block by bupivacaine only
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment