Steroids After Spine Fusion Surgery

Study Overview
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Brief Summary
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This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.

Detailed Description
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PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group. OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.

Official Title
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Postoperative Steroids and Recovery After Spine Fusion

Conditions
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Spine Fusion

Intervention / Treatment
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* Drug: Prednisone 20 Mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included Exclusion Criteria: Patient is already taking chronic steroids Patient is pregnant Patient is decisionally impaired Patient is a prisoner

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Participants are randomized into one of two groups: treatment group vs control (no treatment) group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid<br>Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery | Drug: Prednisone 20 Mg<br>* 20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group<br>* Other names: Dexamethasone Sodium Phosphate 1 mL 4 mg/mL;|
| No Intervention: Control<br>Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalent pain medication use over the length of hospitalization | This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine. | From postoperative admission to discharge, up to 4 weeks | 
| Length of hospital stay after surgery | This will be measured by taking the total minutes the patient stays in the hospital after surgery from time of admission to time of discharge. | From postoperative admission to discharge, up to 4 weeks | 
| Time to first bowel movement in hospital after surgery | This will be measured in the total number of minutes from admission after surgery that it takes for the patient to have their first bowel movement recorded. | From postoperative admission to discharge, up to 4 weeks | 
| Number of major complications reported during hospital stay after surgery | This will be measured in the total number of major complications (any) that occur during the hospital stay after surgery. These include, infection, neurological deficit, myocardial infarction, stroke, pneumonia, pulmonary embolism, and bleeding. | From postoperative admission to discharge, up to 4 weeks | 
| Morphine equivalent pain medication use over the first 48 hours of hospitalization | This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine. | From postoperative admission to 48 hours after |