Postoperative Steroids and Recovery After Spine Fusion
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Morphine equivalent pain medication use over the length of hospitalization
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Corticosteroid
Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery
Intervention: Prednisone 20 Mg (Drug)
Outcomes
Primary Outcomes
Morphine equivalent pain medication use over the length of hospitalization
Time Frame: From postoperative admission to discharge, up to 4 weeks
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Number of major complications reported during hospital stay after surgery
Time Frame: From postoperative admission to discharge, up to 4 weeks
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.
Length of hospital stay after surgery
Time Frame: From postoperative admission to discharge, up to 4 weeks
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.
Time to first bowel movement in hospital after surgery
Time Frame: From postoperative admission to discharge, up to 4 weeks
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.
Morphine equivalent pain medication use over the first 48 hours of hospitalization
Time Frame: From postoperative admission to 48 hours after
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jung Yoo
Principal Investigator
Oregon Health and Science University