Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04568837
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2020-09-21
Brief Title:
Steroids After Spine Fusion Surgery
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Postoperative Steroids and Recovery After Spine Fusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 mgmL of IV dexamethasone sodium phosphate and a control group
OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic andor 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 mgmL dexamethasone sodium phosphate if unable to tolerate oral administration on postoperative days one and two
OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic andor 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 mgmL dexamethasone sodium phosphate if unable to tolerate oral administration on postoperative days one and two
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None