Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population. The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.

Official Title
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Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study

Conditions
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Pain, Postoperative, Opioid Use, Recruitment

Intervention / Treatment
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* Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
* Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10-19 years old Patients undergoing multilevel posterior spinal instrumentation and fusion Undergoing surgery for correction of adolescent idiopathic scoliosis Patients under the care of participating surgeons English Speaking Exclusion Criteria: Patients younger than 10 years old or older than 19 years old Neuromuscular scoliosis Patient under the care of non-participating surgeon performing the procedure History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks) Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin) Allergy, intolerance, or contraindication to any protocol component/study medication/technique Patient or parent refusal Non-english speaking

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESPB with Bupivacaine and Dexamethasone<br>12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight. | Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone<br>* Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.<br>|
| Placebo Comparator: No ESPB<br>12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery. | Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)<br>* Patients who are randomized to this group will not receive a bilateral erector spinae plane block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who receive bilateral, pre-incision ESPB | Rate of adherence, number who enroll, number who receive the intervention and complete all assessments | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Recruitment | Number screened/number enrolled | through study completion, an average of 1 year | 
| Blinding Assessment | Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to. | 24 hours after surgery | 
| Type and incidence of factors preventing performance of the block | Patient, surgical, anesthetic, and/or work flow related barriers | Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery | 
| Attrition | Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons | through study completion, an average of 1 year | 
| Incidence of intra- and postoperative complications attributed to ESPB | Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness | During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery | 
| Pain Scores at Rest and Movement | Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine) | PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery) | 
| Total Opioid Consumption | Measured in mean oral morphine equivalents (OME) | 0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery) | 
| Time to first opioid use | Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid | Up to 24 hours after surgery | 
| Opioid Related Side Effects | Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS) (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much) | 24 hours after surgery | 
| Patient/parent satisfaction with pain management | Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied) | At hospital discharge (average 48 hours after surgery) |