Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 9 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06023043
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Los Angeles
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lindsay Andras, MD
Principal Investigator Affiliation Children's Hospital Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis
Additional Details

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.

Arms & Interventions

Arms

No Intervention: No Steroid (NS)

No Dexamethasone (NS)

Experimental: With Steroid (WS)

With Dexamethasone (WS)

Interventions

Drug: - Dexamethasone

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Los Angeles, Los Angeles, California

Status

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

Tiffany Phan

[email protected]

310-848-8377