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NCT Number: NCT06023043

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

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.

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Key information

Conditions

Neuromuscular Scoliosis Adolescent Idiopathic Scoliosis Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

Lindsay Andras, MD

PRINCIPAL_INVESTIGATOR

Tiffany Phan

CONTACT

[email protected]

3108488377

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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)

Primary outcomes

  1. Length of Stay

    Time frame: 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.

  2. Post Operative Opioid Use

    Time frame: 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)

Secondary outcomes

  1. Post Operative Ambulation (for ambulatory patients)

    Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

    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.

  2. Return of Bowel Function

    Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks

    Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.

  3. Rate of wound complications requiring intervention

    Time frame: Less than 90 days from hospitalization

    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.

  4. Scar Appearance

    Time frame: Immediately from enrollment through study completion, at an average of 2 years

    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).

  5. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Immediately from enrollment through study completion, at an average of 2 years

    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.

  6. Post-Operative Complications

    Time frame: Within 2 years from date of surgery.

    Any additional emergency room visits/readmission or revision surgery

  7. Body Mass Index

    Time frame: Immediately from enrollment through study completion, at an average of 2 years

    Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay M Andras, MD

CONTACT

[email protected]

323-361-2142

Tiffany Phan, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 5, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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