Postoperative Steroids for Scoliosis

Overseen By Tiffany Phan, BA

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Prior spine surgery, Spina bifida, Allergies, Drug or alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Up to 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using the steroid dexamethasone (also known as Decadron, Dexone, or Hexadrol) immediately after surgery can help teens recover faster from spinal fusion surgery for scoliosis. The researchers aim to determine if steroids can reduce the need for painkillers like opioids, help patients start moving earlier, and assess any effects on wound healing and scars. Those between 9 and 18 years old, scheduled for spinal fusion surgery due to adolescent idiopathic scoliosis (AIS) or neuromuscular scoliosis (NMS), may be suitable for this study. Participants will complete surveys and have photos taken of their surgical scar over two years. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Dexamethasone?

Research has shown that dexamethasone, a type of steroid, is generally safe for use after surgery. In a large study of nearly 19,000 hip and knee surgeries, a low dose of dexamethasone did not increase the risk of joint infections, indicating it is well-tolerated post-surgery. Another study on children undergoing spine surgery found that dexamethasone effectively reduced nausea and vomiting without causing major problems. Additionally, when used near nerves, dexamethasone did not cause any nerve damage. Overall, these findings suggest dexamethasone is safe and does not usually cause serious side effects when used after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for scoliosis surgery recovery focus on pain management and reducing inflammation with standard options like NSAIDs and opioids. Dexamethasone is unique because it is a corticosteroid that aims to reduce inflammation more effectively and expedite healing after surgery. Researchers are excited about Dexamethasone because it has the potential to not only manage pain but also minimize swelling, leading to a faster and smoother recovery for patients. This could mean less reliance on pain medications and a quicker return to normal activities.

What evidence suggests that this trial's treatments could be effective for scoliosis?

In this trial, participants will be divided into two groups: one receiving dexamethasone and the other not. Research has shown that dexamethasone, a type of steroid, can be beneficial after spinal surgery. Specifically, previous studies found that dexamethasone reduced the need for opioid painkillers by about 40% post-surgery. This reduction means patients might experience less pain and require fewer pain medications. Additionally, dexamethasone did not increase the risk of wound complications. Evidence also indicates it helps reduce nausea and vomiting after surgery. Overall, these findings suggest dexamethasone can aid recovery and enhance comfort after scoliosis surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Lindsay M Andras, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young people aged 9-18 with Adolescent Idiopathic Scoliosis (AIS) or Neuromuscular Scoliosis (NMS), who are scheduled for posterior spinal fusion surgery. It's not open to those who've had prior spine surgeries, have conditions like spina bifida that affect wound healing, steroid allergies, or substance abuse issues.

Inclusion Criteria

I am between 9 and 18 years old and will have surgery to correct my curved spine.

Individuals must fulfill all the requirements in order to take part in this study.

Exclusion Criteria

I have a condition like spina bifida that affects how my wounds heal.

I have had previous spine surgery or a procedure involving spinal instruments.

Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior spinal fusion surgery with or without immediate postoperative steroid administration

Up to 2 weeks

Hospitalization for surgery until discharge

Follow-up

Participants are monitored for safety, effectiveness, and scar formation after treatment

2 years

Visits at 3 months, 1 year, and 2 years

Long-term Monitoring

Participants complete PROMIS surveys and have clinical photos taken for scar evaluation

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests if using steroids right after scoliosis surgery can reduce pain medication needs and help patients move sooner. It also looks at whether steroids impact wound healing and scar appearance over time. Participants will be randomly assigned to receive steroids post-surgery or not.

How Is the Trial Designed?

Group I: With Steroid (WS) Experimental Treatment 1 Intervention

With Dexamethasone (WS)

Group II: No Steroid (NS) Active Control 1 Intervention

No Dexamethasone (NS)

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

A short course of postoperative dexamethasone after posterior spinal fusion for adolescent idiopathic scoliosis significantly reduced opioid usage by 39.6% without increasing the risk of wound complications, as shown in a study of 113 patients from 2015 to 2018.

Patients receiving steroids were also more likely to walk during their initial physical therapy evaluation, indicating improved recovery outcomes compared to those who did not receive steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Fletcher, ND., Ruska, T., Austin, TM., et al.[2021]

A meta-analysis of five randomized controlled trials found that adding epidural dexamethasone to local anesthetics significantly reduces postoperative morphine consumption by an average of 7.89 mg, indicating its efficacy in pain management.

Patients receiving epidural dexamethasone also required fewer rescue analgesic boluses, with a risk ratio of 0.51, suggesting that it effectively decreases the need for additional pain relief after abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. Jebaraj, B., Khanna, P., Baidya, DK., et al.[2022]

In a study of 18,872 hip and knee arthroplasties, a single low dose of dexamethasone (5-10 mg) did not increase the risk of post-operative prosthetic joint infections (PJIs), indicating its safety for use in these surgeries.

Dexamethasone effectively prevents post-operative nausea and vomiting (PONV) and may help reduce post-operative pain without raising infection rates, making it a beneficial option in multimodal pain management for arthroplasty patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infection safety of dexamethasone in total hip and total knee arthroplasty: a study of eighteen thousand, eight hundred and seventy two operations. Vuorinen, MA., Palanne, RA., Mäkinen, TJ., et al.[2020]

Intraoperative administration of dexamethasone (40 mg) during surgery for cervical spondylotic myelopathy did not improve postoperative outcomes or clinical follow-up scores, indicating it may not be beneficial in this context.

However, patients who received dexamethasone experienced a significantly higher rate of wound healing complications, with five cases compared to none in the non-dexamethasone group, suggesting potential safety concerns with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacking Benefit of Intraoperative High-Dose Dexamethasone in Instrumented Surgery for Cervical Spondylotic Myelopathy. Blume, C., Wiederhold, H., Geiger, M., et al.[2018]

In a study of 100 adolescents undergoing scoliosis correction surgery, a single dose of dexamethasone significantly reduced the incidence of postoperative nausea and vomiting (PONV) compared to a saline control, with rates of 62.5% versus 84.0%.

Dexamethasone also led to lower nausea and pain scores in the first 24 hours post-surgery and did not increase adverse events, indicating it is a safe and effective option for PONV prevention in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prophylactic dexamethasone on postoperative nausea and vomiting in scoliosis correction surgery: a double-blind, randomized, placebo-controlled clinical trial. Wakamiya, R., Seki, H., Ideno, S., et al.[2020]

In a study comparing dexamethasone (Dex) and hydrocortisone (HC) in newborn rats, Dex was found to negatively impact brain and body weight gain, while HC did not have these adverse effects.

Dex increased neurotoxicity markers and impaired learning and memory in juvenile rats, whereas HC, even at high doses, did not affect cognitive behavior, suggesting that HC may be a safer alternative for treating premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone but not the equivalent doses of hydrocortisone induces neurotoxicity in neonatal rat brain. Feng, Y., Kumar, P., Wang, J., et al.[2017]

In a study of 180 patients undergoing elective surgeries with spinal anesthesia, both diabetic and nondiabetic patients experienced a significant increase in blood glucose levels after receiving low doses of dexamethasone (4 mg and 8 mg).

The maximum rise in blood glucose was similar for both groups, reaching about 40-45 mg/dL, indicating that clinicians should carefully consider the potential for hyperglycemia when administering dexamethasone for preventing postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized study on the impact of low-dose dexamethasone on perioperative blood glucose concentrations in diabetics and nondiabetics. Purushothaman, AM., Pujari, VS., Kadirehally, NB., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33086348/

Postoperative Dexamethasone Following Posterior Spinal ... A short course of postoperative steroids after posterior spinal fusion was associated with a 40% decrease in the use of opioids, with no increase in wound ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6376007/

a double-blind, randomized, placebo-controlled clinical trial The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction ...

3. withpower.com withpower.com/trial/phase-4-scoliosis-10-2023-f4c3f

Postoperative Steroids for Scoliosis · Info for Participants A short course of postoperative dexamethasone after posterior spinal fusion for adolescent idiopathic scoliosis significantly reduced opioid usage by 39.6% ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pne2.12117

Posterior spinal fusion for adolescent idiopathic scoliosis ... Dosing consisted of intravenous dexamethasone 0.1 mg/kg up to 4 mg per dose for a total of three doses at 8, 16, and 24 h postoperatively. As ...

5. trial.medpath.com trial.medpath.com/clinical-trial/46a2079ffe687571/randomized-trial-postoperative-steroid-use-spinal-fusion-scoliosis

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis ... The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11163225/

Posterior spinal fusion for adolescent idiopathic scoliosis ... Postoperative intravenous dexamethasone was added to an established postoperative care pathway for patients undergoing posterior spinal fusion for idiopathic ...

7. journals.lww.com journals.lww.com/spinejournal/fulltext/2025/09150/effects_of_perineural_dexamethasone_and.1.aspx

Effects of Perineural Dexamethasone ... Furthermore, no nerve damage was observed in any groups, suggesting that DEM and DEX are safe when administered perineurally in the context of ESPB for ...