A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post Operative Opioid Use
研究概览
简要总结
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:
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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
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Have clinical photos of their incision at 3 months, 1 year, and 2 years
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Their photos will be assessed using the stony book scar evaluation scale
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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.
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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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
With Steroid (WS)
With Dexamethasone (WS)
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Post Operative Opioid Use
时间窗: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
Length of Stay
时间窗: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Day/hours to discharge from hospital following completion of surgery.
次要结局
- Post Operative Ambulation (for ambulatory patients)(From date of hospitalization for surgery until date of first discharge, assessed up to two weeks)
- Scar Appearance(Immediately from enrollment through study completion, at an average of 2 years)
- Post-Operative Complications(Within 2 years from date of surgery.)
- Return of Bowel Function(From date of hospitalization for surgery until date of first discharge, assessed up to two weeks)
- Rate of wound complications requiring intervention(Less than 90 days from hospitalization)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(Immediately from enrollment through study completion, at an average of 2 years)
- Body Mass Index(Immediately from enrollment through study completion, at an average of 2 years)
研究者
Lindsay Andras
Associate Division Chief and Director of the Spine Program
Children's Hospital Los Angeles