Postoperative Dexamethasone for Scoliosis

Overseen By Nicholas Fletcher, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Congenital scoliosis, Pregnant, Prisoners, 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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Inpatient stay (up to 48 hours)

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how dexamethasone, a medication often used to reduce inflammation, can improve recovery after scoliosis surgery. Researchers aim to determine if additional doses of dexamethasone can lower the need for pain medications like morphine, reduce nausea, and shorten hospital stays. Participants will be randomly assigned to receive either one dose during surgery or multiple doses after surgery. This study suits those aged 10-18 with adolescent idiopathic scoliosis planning to undergo spinal fusion surgery at Children's Healthcare of Atlanta Egleston. 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 is generally safe for use in scoliosis surgery. Studies have found that patients tolerate it well during these procedures. Importantly, dexamethasone has been safely used in children, which is crucial for scoliosis surgery.

When administered around a nerve, dexamethasone has shown safety, with no major side effects reported. This is particularly important for those considering surgery for adolescent idiopathic scoliosis, where dexamethasone is already part of some recovery plans.

Overall, the research supports the safe use of dexamethasone in similar surgeries, providing strong evidence for its safety in this clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using dexamethasone for scoliosis surgery because it might improve recovery in a novel way. Typically, scoliosis surgery patients receive a single dose of dexamethasone during the operation as part of standard anesthesia protocols. What makes this approach different is that patients in the study receive additional doses of dexamethasone post-surgery, with three more 8 mg doses administered every eight hours, totaling four doses. This extended dosing could potentially reduce inflammation more effectively, speed up recovery, and improve overall surgical outcomes.

What evidence suggests that dexamethasone might be an effective treatment for scoliosis?

Research has shown that dexamethasone can reduce the need for opioids, which are strong painkillers, after spinal surgery. One study found that using dexamethasone after posterior spinal fusion led to a 40% reduction in opioid use. This is significant because it helps manage pain without over-relying on strong painkillers. In this trial, participants in the dexamethasone arm will receive multiple doses postoperatively to evaluate its effectiveness in reducing pain and potentially shortening hospital stays. The control group will receive a single intraoperative dose as per standard care. Previous studies indicated that using dexamethasone did not increase wound problems, suggesting it can aid recovery after scoliosis surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Nicholas Fletcher, MD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for young people aged 10-18 with a type of scoliosis called AIS, who are having spine surgery (PSF) by Dr. Fletcher at Children's Healthcare of Atlanta Egleston. It's not for those with other types of scoliosis, pregnant women, adults over 18, prisoners, or anyone with systemic fungal infections.

Inclusion Criteria

I am 10-18 years old, have AIS, and am getting a PSF by Dr. Fletcher at Egleston.

Exclusion Criteria

Prisoners

I have a fungal infection in my body.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo posterior spinal fusion surgery and receive dexamethasone or standard care

Inpatient stay (up to 48 hours)

In-hospital stay

Follow-up

Participants are monitored for changes in interleukin-6, C-reactive protein, and total morphine usage

48 hours post-surgery

Daily monitoring during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Standard of Care

Trial Overview The study compares standard care to an enhanced dexamethasone treatment after spine surgery in adolescents. The control group gets one dose during surgery; the test group receives additional doses every 8 hours post-surgery to see if it helps reduce pain and nausea and shortens hospital stays.

How Is the Trial Designed?

Group I: Dexamethasone Experimental Treatment 1 Intervention

Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional (8mg doses) administered at 8-hour intervals following surgery for a total of 4 doses.

Group II: Standard of Care: Control Active Control 1 Intervention

Patients will be screened for participation following indication for surgery by the treating surgeon and/or research assistant. Patients who elect to participate will then be randomized into either the dexamethasone or control groups. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. No sham medication will be utilized for control subjects.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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]

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]

A meta-analysis of 37 studies involving 4603 surgical patients found that dexamethasone does not increase the risk of postoperative wound infections, indicating its safety for use in preventing nausea and vomiting during surgery.

Dexamethasone caused a mild increase in blood glucose levels in non-diabetic patients within the first 12 hours post-surgery, but its effect on wound healing remains unclear due to insufficient evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse side-effects of dexamethasone in surgical patients - an abridged Cochrane systematic review. Polderman, JAW., Farhang-Razi, V., van Dieren, S., et al.[2019]

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 single intravenous dose of dexamethasone administered for postoperative nausea and vomiting (PONV) prophylaxis in diabetic patients significantly increased blood glucose levels, with peak increases of about 2.014 mmol/L (36.252 mg/dL) within 24 hours after surgery.

Despite the increase in blood glucose, dexamethasone did not negatively impact wound healing or infection rates, indicating it can be safely used in diabetic surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of perioperative dexamethasone with antiemetic dosage in surgical patients with diabetes mellitus: a systematic review and meta-analysis. Pang, QY., Wang, JY., Liang, XL., et al.[2023]

A Quality Improvement initiative successfully reduced the length of stay (LOS) after posterior spinal fusion for idiopathic scoliosis patients from 4.93 days to 2.59 days, achieving a discharge rate of 93.48% within 4 days.

The implementation of a new pain management protocol and a daily checklist for postoperative care significantly improved patient outcomes without increasing readmissions or emergency department visits for pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Postoperative Length of Stay for Idiopathic Scoliosis Patients using Quality Improvement Methodology. Seilhamer, C., Miller, K., Holstine, J.[2023]

In a study of 84,320 adolescents with idiopathic scoliosis, the overall complication rate following surgery was found to be low at 1.5%, with a significant decrease from 4.95% in 2004-2007 to 0.98% in 2013-2016, indicating improved surgical outcomes over time.

The most common complications included surgical site infections, new neurological deficits, and implant-related issues, with weak correlations found between complications and factors like curve magnitude and age at surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications following surgery for adolescent idiopathic scoliosis over a 13-year period. Kwan, KYH., Koh, HY., Blanke, KM., et al.[2020]

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

A national study of 51,911 patients undergoing spinal fusion for idiopathic scoliosis revealed that adult patients had a higher in-hospital complication rate (25.1%) compared to pediatric patients (14.9%), highlighting the increased risk associated with adult surgeries.

The in-hospital mortality rates were low at 0.17% for pediatric and 0.40% for adult patients, but complications significantly impacted outcomes, with preoperative comorbidities increasing the likelihood of complications by 1.53 times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient complications, mortality, and discharge disposition after surgical correction of idiopathic scoliosis: a national perspective. Patil, CG., Santarelli, J., Lad, SP., et al.[2008]

In a study of 9,351 pediatric patients undergoing scoliosis surgery, 17% experienced complications, with 12% being cardiopulmonary, highlighting the need for careful monitoring during and after surgery.

Over the study period from 2006 to 2016, the incidence of complications, blood transfusions, length of hospital stay, and costs significantly decreased, suggesting improvements in surgical practices and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and Outcomes in Pediatric Patients Undergoing Scoliosis Repair: A Population-Based Study. DelPizzo, K., Wilson, LA., Fiasconaro, M., et al.[2021]

In a study of 74 diabetic acute burn patients undergoing surgery, those who received intraoperative dexamethasone experienced a significant increase in postoperative blood glucose levels and insulin requirements compared to those who did not receive the steroid.

The complication rate was notably higher in the steroid group (52.9%) compared to controls (20.1%), suggesting that the use of intraoperative steroids may lead to increased risks in diabetic burn patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Intraoperative Dexamethasone Administration in Adult Diabetic Burn Patients. Egan, KG., Allen, A., Hendren, G., et al.[2020]

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/PMC11163225/

Posterior spinal fusion for adolescent idiopathic scoliosis ... Posterior spinal fusion for adolescent idiopathic scoliosis and the impact of postoperative intravenous dexamethasone supplementation.

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

Effects of Perineural Dexamethasone ... Effects of Perineural Dexamethasone and Dexmedetomidine on Neuromonitoring and Analgesia in Pediatric Scoliosis Surgery. A Randomized Controlled Trial.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06789029

The Effect of Dexamethasone Administration Route and Local ... This study aims to compare the effects of different dexamethasone administration routes and local anesthetic concentrations on postoperative pain, inflammation ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772529424005824

Enhanced recovery after adolescent idiopathic scoliosis ... The purpose of this article is to expose our actual ERAS protocol for AIS surgery and compare it with the earlier non ERAS management in our institution.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12369505/

Effects of Perineural Dexamethasone and Dexmedetomidine ... ... DEX are safe when administered perineurally in the context of ESPB for scoliosis surgery. This is particularly important in pediatric populations, where the ...

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

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 ...