Spinal Fusions Steroid Study

Study Overview
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Brief Summary
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Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.

Official Title
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Perioperative IV Steroid Administration Lowers Post-operative Pain Levels and Opioid Use in Pediatric Patients After Posterior Spinal Fusion and Instrumentation for Spine Deformity.

Conditions
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Spinal Fusion

Intervention / Treatment
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* Drug: Dexamethasone injection
* Other: Saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets operative criteria for posterior spinal instrumented fusion for AIS Parental consent Exclusion Criteria: Revision procedure Other associated conditions which may alter the postoperative course

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a double blinded (patient, surgeon) prospective randomized controlled trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid injection<br>Dexamethasone will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs | Drug: Dexamethasone injection<br>* Dexamethasone will be injected at the dosage recommended by the FDA.<br>|
| Placebo Comparator: Saline solution<br>Saline will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs | Other: Saline injection<br>* Saline will be injected for the placebo arm of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial ambulation post-operatively and distance ambulated in first physical therapy session. | The investigators will assess the time to initial ambulation in reference to the surgical stop time recorded in the chart. This time will be calculated in minutes. The total minutes until first ambulation for both arms of the study will be compared. The investigators will assess measure, in feet, the distance patients ambulate during the initial session with physical therapy postoperatively. The distance, in feet, ambulated by patient in each arm of the study will be directly compared. | 1 week | 
| Length of stay in hospital | The investigators will measure the number of days in the hospital from the date of surgery | 1 week | 
| Morphine equivalents use | The investigators will record the amount of morphine equivalents utilized by patients in the post-operative in-hospital period to compare the use of intravenous narcotics in a quantifiable fashion between the two study groups. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to emergency department | The investigators will track rates of return to the Emergency Department and/or return for hospital admission after discharge from the hospital. Rates of return to the Emergency Department and/or need for hospital admission will be stratified across 30 day, 90 day, and 365 day intervals after discharge from the hospital. Additionally, data will be collected by the investigators on the cause of return to the Emergency Department and/or return for hospital admission. Examples of cause for return will include: insufficient pain control at home, concerning neurologic findings, inability to tolerate per os nutrition, inability to urinate or defecate, wound dehiscence or drainage, and all other causes. We will keep track of patients that need to return to the emergency department for any reason. | 12 months | 
| Return to school | The investigators will determine the length of time it takes a patient to return to school after surgery. | 3 months | 
| Pain score at discharge | The investigators will record the patient's pain score at regular intervals during hospital admission (typically assessed every 4 hours by the nursing staff) as well as recording pain score at time of discharge from the hospital. Pain scores will be recorded in two fashions. Primarily, a pain score of 0 to 10 will be recorded whereby a patient-reported score of 0 indicates no perceived pain and a score of 10 would indicate severe and intractable pain. Secondarily, as this study involves pediatric patients, the investigators will record pain using the Wong-Baker FACES Pain Rating Scale that similarly uses a scoring system of 0 to 10, but additionally includes illustrations of faces to guide pediatric patients in relating their pain to a numeric score. The Wong-Baker FACES Pain Rating Scale is a validated tool for recording pain levels in pediatric patients and is widely used within the investigators hospital system. | 1 week |