Perioperative Steroid Dosing on the APR in AIS

Adolescent Idiopathic Scoliosis (AIS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561725
• Other study ID #: STUDY00003378
• Status: Recruiting
• Phase: Phase 4
• Start date: January 3, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: Nicholas Fletcher, MD
• Phone: 404-255-1933
• Email: nicholas.d.fletcher[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis (AIS)
• Scoliosis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in C-Reactive Protein	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.	Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
Primary	Changes in Interleukin-6	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.	Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
Secondary	Changes in Total morphine usage	Changes in total morphine dosage (measured in morphine equivalents) during the hospital stay will be assessed and compared between the two groups.	Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery