Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.

Conditions
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Scoliosis Idiopathic

Intervention / Treatment
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* Drug: Sham block
* Drug: ESPB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 10-18 years old pediatric patients who will undergo the surgical correction of idiopathic scoliosis Exclusion Criteria: a history of chronic pain (use of gabapentin/pregabalin for > 3 months or opioid use > 1 repeated opioid prescription in the last three months) morbid obesity (BMI > 99th percentile) previous surgery back abnormalities infection at block application area coagulopathy

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sham group<br>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 | Drug: Sham block<br>* 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<br>* Other names: 0,9% normal saline;|
| Active Comparator: ESPB group<br>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) | Drug: ESPB<br>* 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)<br>* Other names: 0,2% ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 30 minutes after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 60 minutes after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 90 minutes after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 120 minutes after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 6 hours after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 12 hours hours after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 24 hours after surgery | 
| Pain Numerical Rating Scale | Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain) | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutrophil/lymphocyte ratio | neutrophil/lymphocyte ratio | 12 hours and 24 hours after surgery | 
| platelet/lymphocyte ratio | platelet/lymphocyte ratio | 12 hours and 24 hours after surgery | 
| Nausea or Vomiting | presence or absence | during first 24 hours after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 1 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 2 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 3 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 4 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 5 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 6 after surgery | 
| total opioid consumption | intravenous milligrams of morphine equivalents | Day 7 after surgery | 
| Motor Evoked Potential amplitude | Motor Evoked Potentials durring surgery | up to seven days prior to the correction of scoliosis | 
| Motor Evoked Potential amplitude | Motor Evoked Potentials during surgery | up to 24 weeks following the correction of scoliosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, peripheral nerve block, erector spinae plane block, euromonitoring