Scoliosis Idiopathic Clinical Trial
Official title:
Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial
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.
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.
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