The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.
This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, Poland
RECRUITINGPoznan University of Medical Sciences
Poznan, Poland
RECRUITINGPain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 30 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 60 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 90 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 120 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 6 hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 12 hours hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 24 hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time frame: 48 hours after surgery
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neutrophil/lymphocyte ratio
neutrophil/lymphocyte ratio
Time frame: 12 hours and 24 hours after surgery
platelet/lymphocyte ratio
platelet/lymphocyte ratio
Time frame: 12 hours and 24 hours after surgery
Nausea or Vomiting
presence or absence
Time frame: during first 24 hours after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 1 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 2 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 3 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 4 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 5 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 6 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Time frame: Day 7 after surgery
Motor Evoked Potential amplitude
Motor Evoked Potentials durring surgery
Time frame: up to seven days prior to the correction of scoliosis
Motor Evoked Potential amplitude
Motor Evoked Potentials during surgery
Time frame: up to 24 weeks following the correction of scoliosis