NCT04568837

Steroids After Spine Fusion Surgery

Postoperative Steroids and Recovery After Spine Fusion

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spine Fusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-10-06
• Completion: 2026-10-06
• First posted: 2020-09-29
• Last updated: 2024-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study