Steroids After Spine Fusion Surgery

Phase 4

Not yet recruiting

• Conditions: Spine Fusion
• Interventions: Drug: Prednisone 20 Mg

• Registration Number: NCT04568837
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Study Start: 2025-03-01
• Primary Completion: 2026-10-06
• Study Completion: 2026-10-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Prednisone 20 Mg	Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States