Perioperative Steroid Dosing on the APR in AIS

NCT ID: NCT05561725

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

The objective of this study is 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.

The acute phase response (APR) is the body's response to induced tissue injury to facilitate, survive, and activate tissue repair. Posterior spinal fusion (PSF) is one source of tissue injury that has the potential to evoke an exuberant APR which can lead to a hyper-inflammatory state that can be associated with increased pain and patient morbidity. Perioperative steroid use has emerged as one potential method to minimize the activation of the APR as well as decrease postoperative pain and also narcotic utilization. However, the extent of the steroid usage on abating the activation of the APR in PSF for adolescent idiopathic scoliosis (AIS) has not been previously investigated.

The APR plays significant roles not only in the activation of inflammation postoperatively, but also for hemostasis as it helps trigger the initial fibrin clot to seal bleeding vessels.1 The inflammatory response is a later effect, that again plays a role in coagulation but also guides the transition from the survival phase response following tissue injury to the reparative phase. However, when a hyper-inflammatory state is present due to an exuberant APR activation, this transition to the reparative phase is unable to progress, resulting in a perpetuation of inflammation activation resulting in increased pain, nausea, respiratory distress, venous thromboembolism, infection, and even death.2 The ability to minimize or prevent the development of this hyper-inflammatory state holds significant implications not only for improved post-operative pain and nausea, but also for decreased postoperative complications, decreased length of stay, and resultant decreases in hospital costs.

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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care: Control

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

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.

All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Dexamethasone

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 Type: EXPERIMENTAL

Dexamethasone postoperative

Intervention Type: DRUG

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.

All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Interventions

Dexamethasone postoperative

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.

All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Intervention Type: DRUG

Standard of Care

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.

All patients will undergo a standardized post-operative pathway in the hospital following surgery that has been utilized for all AIS patients at our center since 2014.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients ages 10-18 with AIS who are undergoing a PSF performed by Dr. Nicholas Fletcher at Children's Healthcare of Atlanta Egleston will be considered eligible for the study

Exclusion Criteria

• Patients outside the inclusion parameters or with congenital or syndromic scoliosis
• Adults > 18 years old
• Pregnant women
• Prisoners
• Patients with systemic fungal infections

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Fletcher

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Fletcher, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Children Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicholas Fletcher, MD

Role: CONTACT

nicholas.d.fletcher@emory.edu

404-255-1933

Facility Contacts

Nicholas Fletcher, MD

Role: primary

nicholas.d.fletcher@emory.edu

404-255-1933

Other Identifiers

STUDY00003378

Identifier Type: -

Identifier Source: org_study_id