Steroids After Spine Fusion Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisone 20 Mg.
- Who it may be relevant to
- Registry conditions: Spine Fusion. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Postoperative Steroids and Recovery After Spine Fusion
Overview
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
- 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
Primary outcome measures
- Morphine equivalent pain medication use over the length of hospitalization [Time frame: From postoperative admission to discharge, up to 4 weeks]
- Length of hospital stay after surgery [Time frame: From postoperative admission to discharge, up to 4 weeks]
- Time to first bowel movement in hospital after surgery [Time frame: From postoperative admission to discharge, up to 4 weeks]
- Number of major complications reported during hospital stay after surgery [Time frame: From postoperative admission to discharge, up to 4 weeks]
- Morphine equivalent pain medication use over the first 48 hours of hospitalization [Time frame: From postoperative admission to 48 hours after]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health and Science University — Portland
Identifiers
NCT: NCT04568837 · STUDY00021169