Adolescent Idiopathic Scoliosis (AIS)Phase 4NCT05561725
Perioperative Steroid Dosing on the APR in AIS
A Phase 4 study testing Dexamethasone postoperative in people with Adolescent Idiopathic Scoliosis (AIS), run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Dexamethasone postoperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients outside the inclusion parameters or with congenital or syndromic scoliosis
- Adults > 18 years old
- Pregnant women
- Prisoners
- Patients with systemic fungal infections
Trial locations and contacts
1 site in 1 country.
United States1 site
Children Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis
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.
Read the 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)
- Being tested
- Dexamethasone postoperative, Standard of Care
- Keywords
- Steroid, Perioperative, Posterior Spinal Fusion (PSF), Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone postoperativeDrug
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 CareDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care: Control | Active comparator | 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. Receives: Drug: Standard of Care |
| Dexamethasone | Experimental | 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. Receives: Drug: Dexamethasone postoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
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.
Measured: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery
Secondary outcomes (1)
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.
Measured: Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start3 Jan 2023
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Fletcher, Emory University
- Investigators
- Nicholas Fletcher, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561725
- Sponsor's protocol ID
- STUDY00003378
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Steroid Dosing on the Acute Phase Response in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05561725
- Acronym / sponsor ID
- STUDY00003378
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Steroid, Perioperative, Posterior Spinal Fusion (PSF), Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care: Control | Active comparator | Drug: Standard of CarePatients 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. |
| Dexamethasone | Experimental | Drug: Dexamethasone postoperativePatients 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Patients outside the inclusion parameters or with congenital or syndromic scoliosis
- Adults > 18 years old
- Pregnant women
- Prisoners
- Patients with systemic fungal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone postoperativePatients 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. | Drug | Dexamethasone |
| Standard of CarePatients 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. | Drug | Standard of Care: Control |
Primary outcome
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.
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.
1 secondary outcome
Changes in Total morphine usage
Time frame: Immediately post surgery, 24 hours post-surgery and 48 hours post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Fletcher, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone postoperative in people with Adolescent Idiopathic Scoliosis (AIS), run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in C-Reactive Protein (time frame: Immediately pre-surgery, immediately post-surgery, 24 hours post-surgery, 48 hours post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.