Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy
Condition: Aortic Coarctation; Erector Spinae Plane Block; Paediatric
MeSH terms: Aortic Coarctation
Study type: Interventional
Phase: Phase 3

Summary: 
      Pain is considered to be subjective, however in children it is believed to be felt rather
      than expressed, because they often depend on the caregiver for their safety and well-being.

      There is significant pain after thoracotomy surgery because of pleural and muscular damage,
      ribcage disruption, and intercostal nerve damage during surgery, which if not effectively
      managed, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia,
      and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and
      tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and
      prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric
      patients is mandatory.

      The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread
      popularity during the last 20 years.In addition to the important advantage of hemodynamic
      stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response,
      However, large doses can cause oversedation, respiratory depression, and prolonged mechanical
      ventilation after surgery.

      Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique
      in management of thoracic neuropathic pain guided by ultrasound. It became popular because it
      is much safer and easily administered than other alternative regional techniques as thoracic
      paravertebral and thoracic epidural block.

      To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy
      operations has not been investigated yet.This has encouraged the performance of the present
      study.
    

Detailed description: 
      Our study will be designed to estimate and compare the analgesic effect of single shot
      erector spinae plane block in pediatric patients undergoing aortic coarcitectomy via
      thoracotomy incision versus fentanyl infusion as the control group. Our primary outcome will
      be the total dose of intraoperative fentanyl bouluses.

      Randomization will be achieved by using an online random number generator. Patient codes will
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
      not involved in the study. A medical personnel not involved in patient management will be
      responsible for opening the envelope and give the instructions contained within each envelope
      to the anesthesiologist who is expert in doing the ESPB in patients included within the block
      group. this expert anaesthesiologist will not be involved in collecting data but another
      anaesthesia doctor will be responsible for patient management and collecting the
      intraoperative and postoperative data.

      The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh
      Pediatric Hospital -Cairo University on 28 pediatric patients aged 3 months-12 months, ASA
      III undergoing aortic coarcitectomy (with thoracotomy incision).

      All patients will attend at the pre- anesthesia room with their parents 1 hour before the
      procedure after taking approval of research ethical comittee and informed consent.

      Detailed history from the parents will be taken followed by a full and detailed clinical
      examination of the child then all investigations including CBC, coagulation profile, liver
      enzymes, kidney function tests, Chest x-ray ,echocardiography and blood grouping will be
      checked.

      ECG, pulse oximetry and non-invasive blood pressure will be applied to all patients. All
      patients will be premedicated by intramuscular midazolam 2mg/Kg and atropine 0.2 mg/Kg 20
      minutes before induction of anesthesia.

      Anesthesia will be induced in all patients by sevoflurane 5% in 100% O2 followed by Placement
      of peripheral I.V cannula and IV administration of fentanyl (1-2µg/kg). Oral endotracheal
      intubation will be facilitated by IV atracurium 0.5 mg/kg and then capnogram will be
      connected to monitor End-tidal CO2 and muscle relaxation will be maintained by atracurium
      infusion in a dose of 0.5 mg/ kg/ hr.

      All patients will be mechanically ventilated using pressure controlled mode with FiO2 50%,
      positive end expiratory pressure (PEEP) 5 cmH2O,I: E ratio of 1:2,peak inspiratory pressure
      (PIP) will be set to deliver a tidal volume of 6-8 ml/kg and respiratory rate will be 15 to
      35 cycle / minute according to the age. our aim is to keep end tidal CO2 between 30-40 mmHg.

      Sevoflurane will be used for maintenance of anaesthesia and its MAC will be determined by
      using bispectoral index (targeting 40-60) to standardize the depth of anaesthesia.

      After insertion of a central venous catheter and an arterial cannula , nasopharyngeal
      temperature probe will be placed and the patient's position will be changed from supine to
      right lateral position.
    

Intervention name(s): Fentanyl; Erector spinae plane block
Intervention type(s): Drug; Procedure
Intervention description(s): fentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings.; ultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius, rhomboids major, and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalic direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment