Erector Spinae Plane Block in Scoliotic Adolescents
Condition: Scoliosis Idiopathic; Scoliosis; Adolescence; Erector Spinae Plane Block
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach
      for perioperative pain management with decreasing the opioids requirement, improving recovery
      and decreasing ICU stay.
    

Detailed description: 
      All patients will be assessed clinically and investigated for Pulmonary function test and
      Echocardiography. Laboratory work needed will be: Complete blood count (CBC); prothrombin
      time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT);
      clotting time (CT) and liver function tests.

      an online randomization program (http://www.randomizer.org) will be used to generate random
      list and to allocate patients into the two study groups. Random allocation numbers will be
      concealed in opaque closed envelops.participants and those assessing/analyzing the outcome(s)
      will be blind to group assignment.

      Eutectic Mixture of Local Anesthetics (EMLA) cream will be applied to the site of venous
      puncture. After insertion of venous access, all children will receive midazolam at a dose of
      0.1 mg/Kg. Intraoperative monitoring will include continuous electrocardiogram (ECG), pulse
      oximetry, invasive arterial blood pressure, end-tidal carbon dioxide (CO2), inhaled gas
      analyzer and temperature monitoring.

      General anesthesia will be induced in both groups (Erector Spinae group and control group)
      using propofol 2.5 mg/kg over 20-30 seconds, atracurium 0.5 mg/kg to facilitate endotracheal
      intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and
      atracurium infused as 0.5 mg/kg/hr. All patients will receive IV ranitidine 2 mg/kg,
      ondansetron 0.1 mg/kg, cefotaxime 50 mg/kg and acetaminophen 15 mg/kg. An arterial catheter
      and a urinary catheter will be placed. Then patients will be turned to the prone position.

      In group E: will receive Erector Spinae Plane Block (ESPB) In group C: control group will
      receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision. After end of
      surgery and emergence from anesthesia, patients will receive continuous intravenous morphine
      with 0.03 mg/kg/hr.

      In both groups, if the analgesia obtained from both methods of ESBP or IV fentanyl was
      inadequate in the form of increase in heart rate and or arterial blood pressure by more than
      20% of baseline values during surgery, this warrants the administration of intravenous
      fentanyl (0.5µg/kg). Total blood loss, duration of surgery, number of vertebral levels fixed,
      total fentanyl consumed will be recorded. After completion of surgical procedure and
      emergence from anesthesia the patient will be referred to post-anaesthesia care unit (PACU).
      Quality of analgesia will be assessed immediately postoperative and then at 4, 8, 12, 16, and
      24 hours postoperatively in the Intensive Care Unit (ICU) by using VAS pain score. All
      patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours, ketorolac from
      second day 15 mg q 6 hours, not to exceed 5 days. Patients will also receive ranitidine 2
      mg/kg q 12 hours. Vital signs and urinary output will be monitored. Morphine IV will be given
      as rescue analgesia (20 µg/kg) in all study groups if visual analogue scale (VAS) pain score
      more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr. After reaching maximum
      hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5
      mg/kg. Morphine will be stopped if maximum hourly dose is reached or the patient becomes
      sedated (Ramsay score >2), has a ventilatory rate of <12 bpm, or an oxygen saturation of
      <95%, or has a serious adverse event (allergy, hypotension, severe vomiting).

      Patients will be continuously monitored in the PACU and ICU. Naloxone and full resuscitation
      equipment are available. Time of first need for morphine and total 24 hr morphine consumption
      will be recorded. Complications e.g nausea, vomiting, pruritis or respiratory depression will
      be recorded.
    

Intervention name(s): Erector Spinae Plane Block; Fentanyl; additional Fentanyl; Morphine; rescue Morphine; pethidine; Ketorolac; Acetaminophen
Intervention type(s): Procedure; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.; patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).; patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.; After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.; Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.; After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.; patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.; patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours
Other intervention name(s): fentanyl for induction and maintenance; morphine infusion
Intervention MeSH terms: Acetaminophen; Ketorolac; Fentanyl; Meperidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care