Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

NCT ID: NCT06023043

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Neuromuscular Scoliosis; Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

No Steroid (NS)

No Dexamethasone (NS)

Group Type: NO_INTERVENTION

No interventions assigned to this group

With Steroid (WS)

With Dexamethasone (WS)

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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)

Interventions

Dexamethasone

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Andras

Associate Division Chief and Director of the Spine Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay Andras, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

Central Contacts

Lindsay M Andras, MD

Role: CONTACT

landras@chla.usc.edu

323-361-2142

Tiffany Phan, BA

Role: CONTACT

tphan@chla.usc.edu

Facility Contacts

Tiffany Phan

Role: primary

tphan@chla.usc.edu

3108488377

References

Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.

Reference Type: BACKGROUND

PMID: 24770995 (View on PubMed)

Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.

Reference Type: BACKGROUND

PMID: 27927519 (View on PubMed)

Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.

Reference Type: BACKGROUND

PMID: 33093753 (View on PubMed)

Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.

Reference Type: BACKGROUND

PMID: 33086348 (View on PubMed)

Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.

Reference Type: BACKGROUND

PMID: 24809068 (View on PubMed)

Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.

Reference Type: BACKGROUND

PMID: 25554755 (View on PubMed)

Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.

Reference Type: BACKGROUND

PMID: 34400573 (View on PubMed)

Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.

Reference Type: BACKGROUND

PMID: 30889145 (View on PubMed)

Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.

Reference Type: BACKGROUND

PMID: 28263228 (View on PubMed)

Other Identifiers

CHLA-23-00124

Identifier Type: -

Identifier Source: org_study_id