Spine Fusion
Conditions
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.
Interventions
DRUGPrednisone 20 Mg
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
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized into one of two groups: treatment group vs control (no treatment) group
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine equivalent pain medication use over the length of hospitalization | 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. |
| Length of hospital stay after surgery | 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 | 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. |
| Number of major complications reported during hospital stay after surgery | 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. |
| Morphine equivalent pain medication use over the first 48 hours of hospitalization | 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. |
Countries
United States
Contacts
Primary ContactSpencer J Smith, BS
Outcome results
None listed