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NCT Number: NCT05561725

Perioperative Steroid Dosing on the APR in AIS

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone postoperative

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.

Standard of care

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.

Primary outcomes

  1. Changes in C-Reactive Protein

    Time frame: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery

    Laboratory studies to be collected will include c-reactive protein (CRP). Laboratory studies will be performed prior to surgery, post-operatively in the post-anesthesia care unit, and every morning during the in-hospital stay up to 48 hours. Studies will be analyzed in the hospital laboratory using standard sample analysis. No more than 10cc will be collected at each lab draw.

  2. Changes in Interleukin-6

    Time frame: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery

    Laboratory studies to be collected will include IL-6. Laboratory studies will be performed prior to surgery, post-operatively in the post-anesthesia care unit, and every morning during the in-hospital stay up to 48 hours. Studies will be analyzed in the hospital laboratory using standard sample analysis. No more than 10cc will be collected at each lab draw.

Secondary outcomes

  1. Changes in Total morphine usage

    Time frame: Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery

    Changes in total morphine dosage (measured in morphine equivalents) during the hospital stay will be assessed and compared between the two groups.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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