Steroids After Spine Fusion Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Corticosteroid 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
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
Other Names:
|
| No Intervention: Control Participants in this group will receive no steroids on postoperative day one and two after spine fusion surgery. |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
- Principal Investigator: Jung U Yoo, MD, Department of Orthopaedics and Rehabilitation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00021169