Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery
Condition: Recovery After Cleft Palate Surgery
MeSH terms: Cleft Palate
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A cleft deformity of the lip and/or palate is one of the commonest major birth defects.

      Primary surgery of cleft palates (CP) varies according to the different surgical teams. Its
      peculiarity lies in the numerous care management protocols proposed according to the surgical
      techniques used, operating time (between M3 and M18 of life), anesthetic technique and
      postoperative management.

      This surgery must be associated to a specific care management because of potential associated
      complications, especially the risk of obstruction of the upper respiratory tract and
      respiratory distress majored by the use of morphine anesthetics during and after surgery.

      Adequate postoperative analgesia in children is a vital part of perioperative care. Regional
      block given preoperatively in combination with general anesthesia (GA) provides good
      preemptive analgesia. It is associated with perioperative hemodynamic stability, rapid and
      complete recovery and reduced analgesic requirement in the postoperative period.

      CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the
      risk of postoperative respiratory depression and airway obstruction is important, and
      continuous monitoring is required during the initial 24-h postoperative period. Cleft palate
      surgery is not only painful, but may also compromise the airway, particularly in children
      with craniofacial syndromes. Opiate analgesia has the potential to further compromise the
      airway, whereas bilateral maxillary nerve block can provide analgesia without the risk of
      respiratory depression in these vulnerable patients. Bilateral maxillary nerve block is
      performed using a suprazygomatic approach and is based on a computer tomography study.

      The nerve supply to the hard and soft palate is from the greater and lesser palatine nerves
      passing through the sphenopalatine ganglion. The maxillary nerve (MN) provides sensory
      innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus,
      and the posterior nasal cavity. Maxillary nerve block (MNB) through the infrazygomatic route,
      used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire
      palatine territory. However, this nerve block has led to complications such as orbital
      puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall
      injury.
    

Detailed description: 
      A prospective randomized controlled double blind study using a computer generated
      randomization scheme will be conducted in Assiut University Hospitals and will be carried out
      on 60 children undergoing primary cleft palate repair surgery. Combined general anesthesia
      and regional bilateral maxillary nerve block (MNB) will be used for anesthesia in these
      surgeries.

      The study drugs (used in MNB) and randomization will be prepared by the second anesthetist.
      The MNB and observed parameters (intraoperative and postoperative) will be done by the first
      anesthetist.

      Children will be randomly allocated into one of two groups of 30 patients each:

      Group L: children will receive 0.15 ml/kg of 0.2% Levobupivacaine

      Group B: children will receive 0.15 ml/kg of 0.2% Bupivacaine

      Preoperative Assessment

      The day prior to surgery, all children participating in this study will undergo
      pre-anesthetic checkup (preoperative fitness) including detailed history from the parents,
      thorough general, physical and systematic examinations. Weight and height of all children
      will be carefully recorded.

      Anesthetic Technique

      Premedication: All children will be premedicated with intramuscular midazolam 0.05 mg/kg
      10-20 minutes before induction of general anesthesia.

      Monitoring: Pulse Oxymetry (SaO2), Non-Invasive Mean Arterial Blood Pressure (MABP), ECG, End
      Tidal CO2 (EtCO2) and Non-Invasive Temperature probes will be applied to each patient.

      After 3 minutes of 100% pre-oxygenation, general anesthesia will be induced by Sevoflurane
      inhalation 4-6% MAC via facemask then intravenous line will be secured and intravenous fluids
      (NaCl 0.9%) will be started at the calculated volume and rate. Fentanyl 1 µg/kg and Propofol
      1.5 mg/kg will be given intravenously then intubation with oral RAE tube of the appropriate
      size will be inserted and secured. Assisted ventilation will be adjusted to maintain 30-35
      mmHg EtCO2. Anesthesia will be maintained with 100% O2 and Sevoflurane 2-4% MAC. Broad
      spectrum antibiotic will be given to each child participated in the study.

      Suprazygomatic MNB: Bilateral suprazygomatic MNB will be performed after complete aseptic
      preparation of the skin and before surgery in an anesthetized patient. Success of MNB will be
      assessed by the lack of sympathetic response to surgical stimulation.

      Data Collection

      Demographic data: including age, sex, weight and height.

      Intraoperative data: heart rate (HR), mean arterial pressure (MAP), ECG, SaO2, EtCO2 and
      Sevoflurane MAC % will be measured every 15 minutes after MNB till the end of the surgery.

      Postoperative data: HR, MAP, SaO2 and respiratory rate (RR) will be measured at the same
      times of pain assessment times.

      Pain Severity: pain will be assessed by the second anesthetist blinded to the study drug
      used. Pain score will be evaluated on arrival to recovery room (T0), 1, 2, 4, 6, 8, 12 and 24
      hours using the FLACC pain scale (Face, Legs, Activity, Cry and Consolability scale). If
      FLACC score ≥ 3, IV nalbuphine 0.1 mg/kg will be given for supplemental analgesia.

      Time of the first analgesic requirement, total dose of nalbuphine consumption or any adverse
      effects (sedation, vomiting, respiratory depression, bleeding at the puncture site or any
      systemic toxicity related to the local anesthetic) will also be recorded.

      Sedation score: will be evaluated by the 4 points (1-4) score. (Awake and alert -1, Sedated
      and responding to verbal command-2, Sedated and responding to mild stimulus-3, Sedated and
      responding to moderate to severe physical stimulus-4).

      Blood glucose level will be measured before MNB, 15 minutes after block and 2 hours after end
      of surgery.

      Statistical Analysis

      All data will be collected and processed using SPSS (SPSS Inc., Chicago, Illinois, USA)
      version 20. All results will be expressed as mean ± SD, range, numbers and percentages.
      Categorical data will be compared using Chi-Square test. Non parametric data will be compared
      using the Mann-Whitney U test. Numerical data will be compared using the Independent Samples
      Student t-Test. P ˂ 0.05 will be considered significant.
    

Intervention name(s): Levobupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Children will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB.; Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Levobupivacaine; Bupivacaine; Nerve Block; Cleft Palate