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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Dexamethasone for postoperative recovery in scoliosis surgery?

Research shows that Dexamethasone can help reduce nausea and vomiting after scoliosis surgery and may also decrease the need for pain medication without increasing wound-healing problems. ^{1 2 3 4 5}

Is dexamethasone safe for use in humans after surgery?

Dexamethasone is generally considered safe for use in humans after surgery, as it helps reduce nausea and pain without increasing wound-healing problems or adverse events. However, it can cause an increase in blood sugar levels, which is important to monitor, especially in people with diabetes. ^{1 2 3 6 7}

How does the drug dexamethasone differ from other treatments for scoliosis surgery?

Dexamethasone is unique in scoliosis surgery because it can reduce postoperative nausea and vomiting and decrease opioid use for pain management without increasing wound-healing problems. This makes it different from other treatments that may not address these specific postoperative issues. ^{1 2 3 4 5}

Research Team

Lindsay M Andras, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. [2021]

2. England 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. [2020]

3. India 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. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Lacking Benefit of Intraoperative High-Dose Dexamethasone in Instrumented Surgery for Cervical Spondylotic Myelopathy. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone but not the equivalent doses of hydrocortisone induces neurotoxicity in neonatal rat brain. [2017]

7. Germany 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. [2020]