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

Trial Summary

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 suggests that using dexamethasone after spinal surgery can help patients recover faster and manage pain better, as seen in other orthopedic surgeries, without increasing wound-healing problems. ^{1 2 3 4 5}

Is dexamethasone safe for use after scoliosis surgery?

The use of dexamethasone after scoliosis surgery is considered based on its benefits in other orthopedic surgeries, such as faster recovery and better pain control, without increasing wound-healing problems. ^{2 4 5 6 7}

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

Dexamethasone is unique in scoliosis surgery because it is used postoperatively to potentially reduce opioid use and improve recovery without increasing wound-healing problems, unlike standard treatments that may not include steroids due to concerns about wound complications. ^{2 8 9 10 11}

What is the purpose of this trial?

The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.

Research Team

Nicholas Fletcher, MD

Principal Investigator

Associate Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

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

Reducing Postoperative Length of Stay for Idiopathic Scoliosis Patients using Quality Improvement Methodology. [2023]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

Inpatient complications, mortality, and discharge disposition after surgical correction of idiopathic scoliosis: a national perspective. [2008]

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

Trends and Outcomes in Pediatric Patients Undergoing Scoliosis Repair: A Population-Based Study. [2021]

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

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Complications following surgery for adolescent idiopathic scoliosis over a 13-year period. [2020]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of Intraoperative Dexamethasone Administration in Adult Diabetic Burn Patients. [2020]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

Adverse side-effects of dexamethasone in surgical patients - an abridged Cochrane systematic review. [2019]