Clinical trial NCT05561725: Perioperative Steroid Dosing on the APR in AIS
Official title: The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Adolescent Idiopathic Scoliosis (AIS)
Keywords: Steroid
Perioperative
Posterior Spinal Fusion (PSF)
Dexamethasone
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in C-Reactive Protein
timeFrame: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
measure: Changes in Interleukin-6
timeFrame: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
Secondary outcomes:
measure: Changes in Total morphine usage
timeFrame: Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Associate Professor
name: Nicholas Fletcher, MD
role: PRINCIPAL_INVESTIGATOR
References: