Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Study Overview
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Brief Summary
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The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years Have clinical photos of their incision at 3 months, 1 year, and 2 years Their photos will be assessed using the stony book scar evaluation scale For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.

Detailed Description
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Children remain a vulnerable population historically known to be undertreated and underrecognized for their pain, only perpetuating the complexity of managing pain control in this cohort. Children's Hospital of Los Angeles conducted a study observing patient and family's perioperative perception regarding their posterior spinal fusion and found that pain control is a primary concern, however, surgeons did not share the sentiment. Opioids were primarily the medication of choice with dentists and surgeons accounting for approximately two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and its adverse effects not limited to addiction, providers are gravitating towards alternative multidisciplinary use of medication to manage pain. Though steroids were formerly used for surgical patients, concerns regarding increased surgical site infection and wound healing complications were of major concern. However, to the investigators knowledge, these issues have only been documented with chronic steroid use. The impact of immediate use of steroids postoperatively for accelerated discharge has gained momentum in the literature with its demonstration in facilitating earlier mobility, decreased pain scores, and decreased narcotic usage. A retrospective study suggested that post-operative dexamethasone administration can have the positive effect of reducing opioid use in pediatric PSF patients without increasing wound complications. The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, while also understanding the incidence of wound complications and long-term scar formation. Should the randomized controlled trial align with the literature, the implementation of post-operative steroids could potentially alter standard of care for adolescent PSF patients.

Official Title
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A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)

Conditions
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Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study: • Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS Exclusion Criteria: Patients will be excluded if any of the following criteria are met at baseline: Prior instrumentation or spine surgery Conditions associated with increased wound healing issues such as spina bifida Non AIS or NMS patients Not undergoing PSF Outside the ages of 9-18 Allergies to the steroids and/or their ingredients Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Ages Eligible for Study
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Minimum Age: 9 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Steroid (NS)<br>No Dexamethasone (NS) | |
| Experimental: With Steroid (WS)<br>With Dexamethasone (WS) | Drug: Dexamethasone<br>* Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Day/hours to discharge from hospital following completion of surgery. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | 
| Post Operative Opioid Use | Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg) | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Ambulation (for ambulatory patients) | Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | 
| Return of Bowel Function | Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement. | From date of hospitalization for surgery until date of first discharge, assessed up to two weeks | 
| Rate of wound complications requiring intervention | 3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection. | Less than 90 days from hospitalization | 
| Scar Appearance | Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale. The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best). | Immediately from enrollment through study completion, at an average of 2 years | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) | The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so. PROMIS domains that will be utilized include: pain interference A five-point Likert scale ranging from 1 (never) to 5 (almost always) is used. A higher score is indicative of more problems with pain hindering activities than a lower score. physical activity A five-point Likert scale ranging from 1 (never) to 5 (almost always) is used. A higher score is indicative of engagement with more physical activities than a lower score. mobility A five-point Likert scale ranging from 1 (never) to 5 (almost always) is used. A higher score is indicative of engagement with more mobility than a lower score. | Immediately from enrollment through study completion, at an average of 2 years | 
| Post-Operative Complications | Any additional emergency room visits/readmission or revision surgery | Within 2 years from date of surgery. | 
| Body Mass Index | Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2 | Immediately from enrollment through study completion, at an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid, Dexamethasone, Scoliosis